June 27, 2020

Following promising phase 1 testing, Mayo Clinic is launching phase 2 of a randomized clinical trial of stem cell treatment for patients with severe spinal cord injury. The clinical trial, known as CELLTOP, involves intrathecal injections of autologous adipose-derived stem cells.

"The field of spinal cord injury has seen advances in recent years, but nothing in the way of a significant paradigm shift. We currently rely on supportive care. Our hope is to alter the course of care for these patients in ways that improve their lives," says Mohamad Bydon, M.D., a neurosurgeon at Mayo Clinic in Rochester, Minnesota.

The first participant in the phase 1 trial was a superresponder who, after stem cell therapy, saw significant improvements in the function of his upper and lower extremities.

"Not every patient who receives stem cell treatment is going to be a superresponder. Among the 10 participants in our phase 1 study, we had some nonresponders and moderate responders," Dr. Bydon says. "One objective in our future studies is to delineate the optimal treatment protocols and understand why patients respond differently."

In CELLTOP phase 2, 40 patients will be randomized to receive stem cell treatment or best medical management. Patients randomized to the medical management arm will eventually cross over to the stem cell arm.

Study participants must be age 18 or older and have experienced traumatic spinal cord injury within the past year. The spinal cord injuries must be American Spinal Injury Association (ASIA) grade A or B.

The initial participant in CELLTOP phase 1 sustained a C3-4 ASIA grade A spinal cord injury. As described in the February 2020 issue of Mayo Clinic Proceedings, the neurological examination at the time of the injury revealed complete loss of motor and sensory function below the level of injury.

After undergoing urgent posterior cervical decompression and fusion, as well as physical and occupational therapy, the patient demonstrated improvement in motor and sensory function. But that progress plateaued six months after the injury.

Stem cells were injected nearly a year after his injury and several months after his improvement had plateaued. Clinical signs of efficacy in both motor and sensory function were observed at three, six, 12 and 18 months following the stem cell injection.

"Our patient also reported a strong improvement with his grip and pinch strength, as well as range of motion for shoulder flexion and abduction," Dr. Bydon says.

Spinal cord injury has a complex pathophysiology. After the primary injury, microenvironmental changes inhibit axonal regeneration. Stem cells can potentially provide trophic support to the injured spinal cord microenvironment by modulating the inflammatory response, increasing vascularization and suppressing cystic change.

"In the phase 2 study, we will begin to learn the characteristics of individuals who respond to the therapy in terms of their age, severity of injury and time since injury," says Anthony J. Windebank, M.D., a neurologist at Mayo's campus in Minnesota and director of the Regenerative Neurobiology Laboratory. "We will also use biomarker studies to learn about the characteristics of responders' cells. The next phase would be studying how we can modify everyone's cells to make them more like the cells of responders."

CELLTOP illustrates Mayo Clinic's commitment to regenerative medicine therapies for neurological care. "Our findings to date will be encouraging to patients with spinal cord injuries," Dr. Bydon says. "We are hopeful about the potential of stem cell therapy to become part of treatment algorithms that improve physical function for patients with these devastating injuries."

Bydon M, et al. CELLTOP clinical trial: First report from a phase I trial of autologous adipose tissue-derived mesenchymal stem cells in the treatment of paralysis due to traumatic spinal cord injury. Mayo Clinic Proceedings. 2020;95:406.

Regenerative Neurobiology Laboratory: Anthony J. Windebank. Mayo Clinic.

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Stem cell treatment after spinal cord injury: The next ...

Spinal Cord Stem Cells Comments Off on Stem cell treatment after spinal cord injury: The next … | October 27th, 2020

Stem Cell Assay Market: Snapshot

Stem cell assay refers to the procedure of measuring the potency of antineoplastic drugs, on the basis of their capability of retarding the growth of human tumor cells. The assay consists of qualitative or quantitative analysis or testing of affected tissues andtumors, wherein their toxicity, impurity, and other aspects are studied.

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With the growing number of successfulstem cell therapytreatment cases, the global market for stem cell assays will gain substantial momentum. A number of research and development projects are lending a hand to the growth of the market. For instance, the University of Washingtons Institute for Stem Cell and Regenerative Medicine (ISCRM) has attempted to manipulate stem cells to heal eye, kidney, and heart injuries. A number of diseases such as Alzheimers, spinal cord injury, Parkinsons, diabetes, stroke, retinal disease, cancer, rheumatoid arthritis, and neurological diseases can be successfully treated via stem cell therapy. Therefore, stem cell assays will exhibit growing demand.

Another key development in the stem cell assay market is the development of innovative stem cell therapies. In April 2017, for instance, the first participant in an innovative clinical trial at the University of Wisconsin School of Medicine and Public Health was successfully treated with stem cell therapy. CardiAMP, the investigational therapy, has been designed to direct a large dose of the patients own bone-marrow cells to the point of cardiac injury, stimulating the natural healing response of the body.

Newer areas of application in medicine are being explored constantly. Consequently, stem cell assays are likely to play a key role in the formulation of treatments of a number of diseases.

Global Stem Cell Assay Market: Overview

The increasing investment in research and development of novel therapeutics owing to the rising incidence of chronic diseases has led to immense growth in the global stem cell assay market. In the next couple of years, the market is expected to spawn into a multi-billion dollar industry as healthcare sector and governments around the world increase their research spending.

The report analyzes the prevalent opportunities for the markets growth and those that companies should capitalize in the near future to strengthen their position in the market. It presents insights into the growth drivers and lists down the major restraints. Additionally, the report gauges the effect of Porters five forces on the overall stem cell assay market.

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Global Stem Cell Assay Market: Key Market Segments

For the purpose of the study, the report segments the global stem cell assay market based on various parameters. For instance, in terms of assay type, the market can be segmented into isolation and purification, viability, cell identification, differentiation, proliferation, apoptosis, and function. By kit, the market can be bifurcated into human embryonic stem cell kits and adult stem cell kits. Based on instruments, flow cytometer, cell imaging systems, automated cell counter, and micro electrode arrays could be the key market segments.

In terms of application, the market can be segmented into drug discovery and development, clinical research, and regenerative medicine and therapy. The growth witnessed across the aforementioned application segments will be influenced by the increasing incidence of chronic ailments which will translate into the rising demand for regenerative medicines. Finally, based on end users, research institutes and industry research constitute the key market segments.

The report includes a detailed assessment of the various factors influencing the markets expansion across its key segments. The ones holding the most lucrative prospects are analyzed, and the factors restraining its trajectory across key segments are also discussed at length.

Global Stem Cell Assay Market: Regional Analysis

Regionally, the market is expected to witness heightened demand in the developed countries across Europe and North America. The increasing incidence of chronic ailments and the subsequently expanding patient population are the chief drivers of the stem cell assay market in North America. Besides this, the market is also expected to witness lucrative opportunities in Asia Pacific and Rest of the World.

Global Stem Cell Assay Market: Vendor Landscape

A major inclusion in the report is the detailed assessment of the markets vendor landscape. For the purpose of the study the report therefore profiles some of the leading players having influence on the overall market dynamics. It also conducts SWOT analysis to study the strengths and weaknesses of the companies profiled and identify threats and opportunities that these enterprises are forecast to witness over the course of the reports forecast period.

Some of the most prominent enterprises operating in the global stem cell assay market are Bio-Rad Laboratories, Inc (U.S.), Thermo Fisher Scientific Inc. (U.S.), GE Healthcare (U.K.), Hemogenix Inc. (U.S.), Promega Corporation (U.S.), Bio-Techne Corporation (U.S.), Merck KGaA (Germany), STEMCELL Technologies Inc. (CA), Cell Biolabs, Inc. (U.S.), and Cellular Dynamics International, Inc. (U.S.).

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Stem Cell Assay Market expected to Witness a Sustainable Growth over 2025 - TechnoWeekly

Spinal Cord Stem Cells Comments Off on Stem Cell Assay Market expected to Witness a Sustainable Growth over 2025 – TechnoWeekly | October 23rd, 2020

Many of the symptoms experienced by people infected with SARS-CoV-2 involve the nervous system. Patients complain of headaches, muscle and joint pain, fatigue and brain fog, or loss of taste and smellall of which can last from weeks to months after infection. In severe cases, COVID-19 can also lead to encephalitis or stroke. The virus has undeniable neurological effects. But the way it actually affects nerve cells still remains a bit of a mystery. Can immune system activation alone produce symptoms? Or does the novel coronavirus directly attack the nervous system?

Some studiesincluding a recent preprint paper examining mouse and human brain tissueshow evidence that SARS-CoV-2 can get into nerve cells and the brain. The question remains as to whether it does so routinely or only in the most severe cases. Once the immune system kicks into overdrive, the effects can be far-ranging, even leading immune cells to invade the brain, where they can wreak havoc.

Some neurological symptoms are far less serious yet seem, if anything, more perplexing. One symptomor set of symptomsthat illustrates this puzzle and has gained increasing attention is an imprecise diagnosis called brain fog. Even after their main symptoms have abated, it is not uncommon for COVID-19 patients to experience memory loss, confusion and other mental fuzziness. What underlies these experiences is still unclear, although they may also stem from the body-wide inflammation that can go along with COVID-19. Many people, however, develop fatigue and brain fog that lasts for months even after a mild case that does not spur the immune system to rage out of control.

Another widespread symptom called anosmia, or loss of smell, might also originate from changes that happen without nerves themselves getting infected. Olfactory neurons, the cells that transmit odors to the brain, lack the primary docking site, or receptor, for SARS-CoV-2, and they do not seem to get infected. Researchers are still investigating how loss of smell might result from an interaction between the virus and another receptor on the olfactory neurons or from its contact with nonnerve cells that line the nose.

Experts say the virus need not make it inside neurons to cause some of the mysterious neurological symptoms now emerging from the disease. Many pain-related effects could arise from an attack on sensory neurons, the nerves that extend from the spinal cord throughout the body to gather information from the external environment or internal bodily processes. Researchers are now making headway in understanding how SARS-CoV-2 could hijack pain-sensing neurons, called nociceptors, to produce some of COVID-19s hallmark symptoms.

Neuroscientist Theodore Price, who studies pain at the University of Texas at Dallas, took note of the symptoms reported in the early literature and cited by patients of his wife, a nurse practitioner who sees people with COVID remotely. Those symptoms include sore throat, headaches, body-wide muscle pain and severe cough. (The cough is triggered in part by sensory nerve cells in the lungs.)

Curiously, some patients report a loss of a particular sensation called chemethesis, which leaves them unable to detect hot chilies or cool peppermintsperceptions conveyed by nociceptors, not taste cells. While many of these effects are typical of viral infections, the prevalence and persistence of these pain-related symptomsand their presence in even mild cases of COVID-19suggest that sensory neurons might be affected beyond normal inflammatory responses to infection. That means the effects may be directly tied to the virus itself. Its just striking, Price says. The affected patients all have headaches, and some of them seem to have pain problems that sound like neuropathies, chronic pain that arises from nerve damage. That observation led him to investigate whether the novel coronavirus could infect nociceptors.

The main criteria scientists use to determine whether SARS-CoV-2 can infect cells throughout the body is the presence of angiotensin-converting enzyme 2 (ACE2), a protein embedded in the surface of cells. ACE2 acts as a receptor that sends signals into the cell to regulate blood pressure and is also an entry point for SARS-CoV-2. So Price went looking for it in human neurons in a study now published in the journal PAIN.

Nociceptorsand other sensory neuronslive in discreet clusters, found just outside the spinal cord, called dorsal root ganglia (DRG). Price and his team procured nerve cells donated after death or cancer surgeries. The researchers performed RNA sequencing, a technique to determine which proteins a cell is about to produce, and they used antibodies to target ACE2 itself. They found that a subset of DRG neurons did contain ACE2, providing the virus a portal into the cells.

Sensory neurons send out long tendrils called axons, whose endings sense specific stimuli in the body and then transmit them to the brain in the form of electrochemical signals. The particular DRG neurons that contained ACE2 also had the genetic instructions, the mRNA, for a sensory protein called MRGPRD. That protein marks the cells as a subset of neurons whose endings are concentrated at the bodys surfacesthe skin and inner organs, including the lungswhere they would be poised to pick up the virus.

Price says nerve infection could contribute to acute, as well as lasting, symptoms of COVID. The most likely scenario would be that the autonomic and sensory nerves are affected by the virus, he says. We know that if sensory neurons get infected with a virus, it can have long-term consequences, even if the virus does not stay in cells.

But, Price adds, it does not need to be that the neurons get infected. In another recent study, he compared genetic sequencing data from lung cells of COVID patients and healthy controls and looked for interactions with healthy human DRG neurons. Price says his team found a lot of immune-system-signaling molecules called cytokines from the infected patients that could interact with receptors on neurons. Its basically a bunch of stuff we know is involved in neuropathic pain. That observation suggests that nerves could be undergoing lasting damage from the immune molecules without being directly infected by the virus.

Anne Louise Oaklander, a neurologist at Massachusetts General Hospital, who wrote a commentary accompanying Prices paper in PAIN, says that the study was exceptionally good, in part because it used human cells. But, she adds, we dont have evidence that direct entry of the virus into [nerve] cells is the major mechanism of cellular [nerve] damage, though the new findings do not discount that possibility. It is absolutely possible that inflammatory conditions outside nerve cells could alter their activity or even cause permanent damage, Oaklander says. Another prospect is that viral particles interacting with neurons could lead to an autoimmune attack on nerves.

ACE2 is widely thought to be the novel coronaviruss primary entry point. But Rajesh Khanna, a neuroscientist and pain researcher at the University of Arizona, observes that ACE2 is not the only game in town for SARS-CoV-2 to come into cells. Another protein, called neuropilin-1 (NRP1), could be an alternate doorway for viral entry, he adds. NRP1 plays an important role in angiogenesis (the formation of new blood vessels) and in growing neurons long axons.

That idea came from studies in cells and in mice. It was found that NRP1 interacts with the viruss infamous spike protein, which it uses to gain entry into cells. We proved that it binds neuropilin and that the receptor has infectious potential, says virologist Giuseppe Balistreri of the University of Helsinki, who co-authored the mouse study, which was published in Sciencealong with a separate study in cells. It appears more likely that NRP1 acts as a co-factor with ACE2 than that the protein alone affords the virus entry to cells. What we know is that when we have the two receptors, we get more infection. Together, its much more powerful, Balistreri adds.

Those findings piqued the interest of Khanna, who was studying vascular endothelial growth factor (VEGF), a molecule with a long-recognized role in pain signaling that also binds to NRP1. He wondered whether the virus would affect pain signaling through NRP1, so he tested it in rats in a study that was also published in PAIN. We put VEGF in the animal [in the paw], and lo and behold, we saw robust pain over the course of 24 hours, Khanna says. Then came the really cool experiment: We put in VEGF and spike at the same time, and guess what? The pain is gone.

The study showed what happens to the neurons signaling when the virus tickles the NRP1 receptor, Balistreri says. The results are strong, demonstrating that neurons activity was altered by the touch of the spike of the virus through NRP1.

In an experiment in rats with a nerve injury to model chronic pain, administering the spike protein alone attenuated the animals pain behaviors. That finding hints that a spike-like drug that binds NRP1 might have potential as a new pain reliever. Such molecules are already in development for use in cancer.

In a more provocative and untested hypothesis, Khanna speculates that the spike protein might act at NRP1 to silence nociceptors in people, perhaps masking pain-related symptoms very early in an infection. The idea is that the protein could provide an anesthetic effect as SARS-CoV-2 begins to infect a person, which might allow the virus to spread more easily. I cannot exclude it, says Balistreri. Its not impossible. Viruses have an arsenal of tools to go unseen. This is the best thing they know: to silence our defenses.

It still remains to be determined whether a SARS-CoV-2 infection could produce analgesia in people. They used a high dose of a piece of the virus in a lab system and a rat, not a human, Balistreri says. The magnitude of the effects theyre seeing [may be due to] the large amount of viral protein they used. The question will be to see if the virus itself can [blunt pain] in people.

The experience of one patientRave Pretorius, a 49-year-old South African mansuggests that continuing this line of research is probably worthwhile. A motor accident in 2011 left Pretorius with several fractured vertebrae in his neck and extensive nerve damage. He says he lives with constant burning pain in his legs that wakes him up nightly at 3 or 4 A.M. It feels like somebody is continuously pouring hot water over my legs, Pretorius says. But that changed dramatically when he contracted COVID-19 in July at his job at a manufacturing company. I found it very strange: When I was sick with COVID, the pain was bearable. At some points, it felt like the pain was gone. I just couldnt believe it, he says. Pretorius was able to sleep through the night for the first time since his accident. I lived a better life when I was sick because the pain was gone, despite having fatigue and debilitating headaches, he says. Now that Pretorius has recovered from COVID, his neuropathic pain has returned.

For better or worse, COVID-19 seems to have effects on the nervous system. Whether they include infection of nerves is still unknown like so much about SARS-CoV-2. The bottom line is that while the virus apparently can, in principle, infect some neurons, it doesnt need to. It can cause plenty of havoc from the outside these cells.

Read more about the coronavirus outbreak from Scientific American here. And read coverage from our international network of magazines here.

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What We Know So Far about How COVID Affects the Nervous System - Scientific American

Spinal Cord Stem Cells Comments Off on What We Know So Far about How COVID Affects the Nervous System – Scientific American | October 23rd, 2020

If you've suffered a spinal cord injury, it is only natural for you to search out the latest breakthroughs in medicine and technology to find a treatment that can get you back to the way things used to be. And one promising branch of current medical research is in the direction of stem cell therapy. But it's important to understand the scope of this relatively new science and to have realistic expectations about the outcomes.

We often get this question, in various forms, from people who suffer from spinal cord injuries:

Is stem cell therapy a cure?

Well, as of today, the sad answer is no. There is no evidence, so far, that stem cell therapy can cure a spinal cord injury. But I'd suggest that the real question they should be asking is this:

Does stem cell therapy have the ability to help after a spinal cord injury?

The answer to this question isn't that firm, but it is a lot more hopeful than the other question. The answer is maybe, sometimes, and we don't know. The reason for this ambiguity is that stem cell therapy for spinal cord injuries is in its infancy as a treatment. In fact, as of January of 2020, the FDA hasn't approved any stem cell therapies for this purpose. So, these treatments are not available in the mainstream medical market. The U.S. Food and Drug Administration has even expressed concerns that patients seeking cures and remedies are vulnerable to stem cell treatments that are currently illegal and potentially harmful.

So, the good news is that there have been some newsworthy and amazing stories of recoveries after stem cell treatments. The unfortunate news is that you won't be able to get stem cell treatment for your SCI through traditional hospital care.

While commercially available stem cell therapies are not available, there are plenty of existing clinical trials out there for which you might qualify. And, a lot of progress is being made in this area. These ongoing trials are being held at various locations around the United States.

Some of these trials focus on individuals who are in the acute stage of their SCI. That generally means they are patients still within 72 hours of the initial injury. Given the short time range on these tests, it is not generally possible to volunteer for them. Rather, the doctors administering the clinical trials will generally seek out patients in the hospital as participants.

There are other trials, however, that are researching the effects of stem cell therapy on patients months or even years after an injury. These are the kinds of trials that patients can apply for and have any real hope of participating.

So, the main point is that, when you're researching trials, it's very important to consider the qualifications. If you don't meet the criterea, you're wasting your time.

With that in mind, if you've decided to pursue clinical trials as a source of treatment, there are a couple of really great resources that can help you to find the right study for you. There are two websites that you can use. They are scitrials.org and clinicaltrials.gov.

This website can really help you to narrow down the search when you're looking for different experimental therapies that could be helpful for your treatment. On the site, you can search for trials based on geographic location, the level of injury, the age of the injury, and you can even use a keyword search.

This is a much larger website, and a much larger resource. And, it's run by the government. It is definitely worth reviewing, especially if you couldn't find what you were looking for at scitrials.org. On the downside, the sheer breadth of information can be overwhelming. Clinicaltrials.gov lists virtually every clinical trial that's going on in the United States. So, that's an enormous amount of information to sift through. But, you can never have too much information, and you're often better off starting with a large amount of information and narrowing it down.

When applying for clinical trials, you will probably be submitting more than one application. Be sure to keep a spreadsheet or some kind of list to keep track of the trials you've already researched, the ones you've applied for, and the responses that you get. Understanding the responses, especially, helps you to improve the quality of future applications. And, it can help you to avoid wasting precious time effort applying for trials that you're not even qualified for.

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Stem Cell Therapies for Spinal Cord Injuries

Spinal Cord Stem Cells Comments Off on Stem Cell Therapies for Spinal Cord Injuries | October 17th, 2020

Immuno-oncology and CAR T cells energized the field of regenerative medicine, but for cell and gene to deliver on their promises, new, disruptive technologies and new modes of operation are needed. Specifically, that entails improving manufacturing to control variables and thus ensure product consistency, and maturing the regulatory environment to improve predictability.

Manufacturing cells is not like manufacturing small molecules, Brian Culley, CEO of Lineage Cell Therapeutics, told BioSpace. For cell therapy products to mature into real products that deliver on the promises of 10 years ago, they must be scalable which drives affordability and they must solve their purity issues.

On the clinical side, cell and gene therapies must find places where small molecules, antibodies or other traditional approaches may not be the best option.

For example, The era of transplant medicine is unfolding before us, Culley said. Because of the transplant component, cell therapy may enable changes the body never could do alone.

Lineage is addressing dry AMD and spinal cord injuries with two of its therapeutics.

Our approach is fundamentally different from traditional approaches. We replace the entire cell rather than modulate a pathway. There is a rational hypothesis where cell therapy can win, but first we need to fix the operational hurdles, Culley said.

To address the manufacturing challenges, Culley said, We work only with allogeneic approaches. For us, not being patient-specific is a huge advantage.

Not long ago, the industry was focused on 3D manufacturing in bioreactors.

Were beyond that, Culley said. For our dry AMD product, we can manufacture 5 billion retinal cells in a three liter bioreactor. The advantage is that the cells exist in a very homogenous space and are 99% pure.

As a result, they are more affordable and can be harvested with little manipulation.

Manual manipulation affects gene expression, he pointed out, so minimizing that, as well as the vast quantities of plastics typically required, results in a more controlled process and a more consistent product.

Additionally, Lineage introduced a thaw and inject formulation, so the cell therapy can be thawed in a water bath, loaded into a chamber and injected, all within a few minutes. Traditional dose administration requires washing, plating and reconstituting the cells the before they are administered to a patient.

Getting rid of the prior day dose prep is one example of the maturation of the field, which we are deploying today to help usher in a new branch of medicine, Culley said.

At Lineage, were tackling problems that largely were intractable. For dry AMD, theres nothing approved by the FDA. No one know why the retinal cells die off, so we manufacture brand new retinal cells (OpRegen) and implant them, Culley said. Were seeing very encouraging clinical signs, including the first-ever case of retinal restoration.

Retinal cells compose a thin layer in the back of the eye, Culley explained.

They start to die off in one spot, and that area grows outward. When we inject our manufactured cells where the old ones died, weve seen the damaged area shrink and the architecture in previously damage areas completely restored, Culley said. Weve treated 20 patients for dry AMD in, ostensibly, safety trials, but you cant help but notice efficacy when a patient reads five more lines on an eye chart. Its hard to imagine our intervention wasnt responsible for that, especially when humans cant regenerate retinal tissue.

The spinal injury program (OPC1) may represent an even greater breakthrough. As with dry AMD, there is no FDA-approved therapy.

We manufacture oligodendrocytes and transport them into the spinal cord, to help produce the myelin coating for axons, he told BioSpace. Because of the oligodendrocytes, the axons grow, become myelinated, and begin to function. Small molecule and antibody therapies havent been able to do that.

So far, 25 people have been treated in a Phase I/II trial. Culley reported cases in which a quadriplegic man, after OPC1 therapy, is now typing 30 to 40 words per minute, and another who now can throw a baseball. Its not unusual for patients who initially were completely paralyzed to now schedule their treatments around college classes, Culley said.

Humans can have varying degrees of recovery from spinal cord injury, but these are higher than we would expect, Culley said.

Other cell and gene companies are advancing solutions, too.

Many companies with induced pluripotent stem cells (iPSCs) are trying to figure out how to get scalability, purity, and reproducibility to work for them. Its not a quick fix, he said.

One of the challenges is balancing the clinical and manufacturing aspects of development.

If you have a technology thats not yet commercially viable, but you have clinical evidence, its tempting to focus on the clinical side, Culley said.

Too many companies do that, and then find their candidate must be reworked for scale up. Therefore, consider scale up and manufacturing early.

Theres a need for balance at a more granular level, too. For example, he asked, How many release criteria do you need? Just because you know a cell expresses a certain surface marker, does that add to your process? Ive seen companies ruined by trying to be perfect, and others by rushing headlong, seeing evidence where evidence doesnt exist.

As Lineage matures its processes to support larger clinical trials, the greatest challenges have been time It takes 30 to 40 days to grow cells, Culley said and regulatory uncertainty. Often, there is no regulatory precedence so there are holes to be addressed. For example, cell and gene therapies sometimes have a delivery component such as a scaffold or delivery encapsulation technology that also must be considered. Real-time regulatory feedback isnt available, so you proceed, presuming that what youre doing will be acceptable to regulators.

The FDA recognizes that new, disruptive technologies and approaches are being used, and must be used, for cell and gene therapy to reach patients.

The FDA is responsive and is trying to push guidance out, Culley said, but it takes time.

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Disruptive Technologies and Mature Regulatory Environment Vital for Cell Therapy Maturation - BioSpace

Spinal Cord Stem Cells Comments Off on Disruptive Technologies and Mature Regulatory Environment Vital for Cell Therapy Maturation – BioSpace | October 17th, 2020

Sixteen years ago, voters were promised that $3 billion of bonds for embryonic stem-cell research would deliver cures for diseases such as diabetes, Alzheimers, Parkinsons and heart disease.

Instead, weve gotten cures or potential treatments for a very different and unexpected set of afflictions, such as a deadly immune disorder, spinal cord injury, a type of cancer and a form of blindness.

The moral of the story as Californians decide whether to continue support by approving Proposition 14s nearly doubled research budget of $5.5 billion is this: Science marches to its own beat and on its own clock, awe-inspiring but oblivious to political pledges.

We got things, but not necessarily what we expected, said Hank Greely, director of Stanfords Center for Law and the Biosciences. Its saving lives, but not in the way most people thought.

Without Proposition 71, the ambitious 2004 ballot measure that first paid for the stem-cell research, 8-year-old Evangelina Vacarro of Corona might be in a casket, rather than skateboarding, horseback riding and playing in the dirt with her pet terrier Daisy.

The engaging hazel-eyed child was born with a rare disease that left her unable to fight off infections. In a clinical trial funded by the state initiative, scientists corrected the deadly genetic flaw that disabled her immune system and restored her to health.

Jake Javier, a biomedical engineering student at Cal Poly, might be unable to live independently. Paralyzed in a diving accident, the 22-year-old gained some function in his arms and hands after the introduction of specialized neural cells in a clinical trial funded by Proposition 71.

It completely changed the trajectory of my life, said Javier, of San Ramon.

Sandra Dillon, a San Diego graphic designer diagnosed at age 28 with a rare form of blood cancer called myelofibrosis, is now in remission after treatment with an FDA-approved drug that was identified through Prop. 71 funding. No longer hospitalized, shes backpacking and surfing.

Before injection with stem cells to combat progressive blindness caused by retinitis pigmentosa, Rosie Barrero of Los Angeles could only see shadows. Now she can discern the time on her cell phone, the colors of kitchen cups and the faces of her family.

In addition to these and more than 60 other clinical trials, the California Institute for Regenerative Medicine (CIRM) created under Proposition 71 has led to about 3,000 peer-reviewed research papers and 974 patents or patent applications.

It has helped bankroll 12 elegant research facilities, donating $43 million to Stanford for the Lorry I. Lokey Stem Cell Research Building, $20 million to the Buck Institutes Regenerative Medicine Research Center in Novato, $20 million to UC Berkeleys Li Ka Shing Center and $35 million to UCSFs Regeneration Medicine Building. It funded five stem cell-focused clinics at hospitals to accelerate the delivery of therapies.

It has generated $293.6 million in direct income and taxes on corporate profits and sales of equipment and supplies, according to an estimate by research professors Dan Wei and Adam Rose of the University of Southern California.

And it has vaulted California to a leadership role in the nations stem-cell science.

CIRM has supported some really superb research and researchers and built a powerful infrastructure, said Robert Cook-Deegan of the School for the Future of Innovation in Society at Arizona State University. In a field where there arent as many other sources of funding, thats almost certainly, in the long run, a good thing.

This is stunning progress for an effort that faced bleak prospects after then-President George W. Bushs federal funding restrictions on embryo research.

Still, it falls far short of Proposition 71s breathless rhetoric from the 2004 campaign.

Stem Cell Research: Breakthrough cures for diseases that affect millions of people, asserted the campaign literature. In a 30-second commercial, actor Michael J. Fox, diagnosed with Parkinsons disease, urged voters to please support the effort to find cures, to save the life of someone you love. Other A-list celebrities, as well as more than 20 Nobel Prize-winning scientists, also promoted it.

Prop 71 will help reduce skyrocketing health care costs, the campaign promised.

The measure was tied up by litigation and the effort got off to a late start. Now, one-third of the way through the bonds 35-year payback period, its nowhere near yielding the $2.2 to $4.4 billion in projected state revenues or $1.1 billion in royalty revenues. To date, only $517,989 in royalties has been paid to the state general fund.

And with only two products FDA-approved and no therapies yet in widespread use, theres so far no evidence that Proposition 71 has delivered the anticipated $3.4 to $6.9 billion state health care savings and $9.2 to $18.4 billion in savings for other payers.

Initial CIRM funding created fewer California jobs than expected: 27,208 jobs per year, according to the USC report, rather than the estimated 47,000 jobs per year.

There have been clinical challenges. A cure for diabeteshas been tougher than expected: A promising approach has lagged because the bodys immune system rejects the pouch that holds implanted, insulin-producing cells. A leukemia cure, seemingly around the corner, has been stymied because blood-forming stem cells are stubbornly reluctant to multiply.

If it all worked, it wouldnt be research, said Stanfords Greely. Politics has a corrupting influence on everything it pushes toward exaggeration.

There have also been business failures. More than $5 million was invested in a promising brain cancer treatment called ICT-107, but efforts were abandoned when company ImmunoCellular Therapeutics ran out of money. Another $3 million was for naught when company Neostem couldnt find funding and swapped CEOs, dropping its melanoma treatment CLBS20.

Even some home runs, such as Gileads recent $4.9 billion deal for the CIRM-supported immuno-oncology biotech Forty Seven, offer taxpayers relatively little payoff. While CIRM expects royalties from Gileads future cancer cure, it didnt benefit from an explosive jump in share prices because the state Constitution bars state agencies from holding stock in private companies.

I think the big downside of CIRM has been the overpromising of how fast things would happen and the form that the return would take, said Cook-Deegan. The commercial potential may be real in the long runbut it was oversold with shorter time horizons than are actually practical.

Proposition 14 will cost far more: $7.8 billion $5.5 billion in principal and $2.3 billion in interest by the time the bonds are repaid. The total cost of Proposition 71 is $3.54 billion, or more than $4 billion when adjusted for inflation. The increase is necessary due to the soaring cost of clinical trials, said Robert Klein, the author of both measures

As voters consider whether to support the new proposition, its unfair to measure it against the prior propositions current trajectory, because medicine reaps its greatest rewards many years after the initial investment, said Klein. It takes 12 to 15 years, on average, to go from discovery to therapy.

It would be similar to judging the Apollo 11 mission when the capsule was a little past a third of the way to the moon and find it coming up short because not one of the three astronauts had set foot on the lunar surface, said Klein.

But critics say Proposition 14 commits California to spending money it does not have. It adds future debt, while education, health care and housing are underfunded.

While I think CIRM has done good work, and I support stem-cell research, the state is facing a huge budget deficit, said Jeff Sheehy, a CIRM board member. And the new measure fails to ensure that the state gets a return on its investment. Instead, it is a giveaway to pharma and biotech.

Theres no longer a compelling rationale for California to support the research because the federal ban has been lifted, with NIH spending about $300 million a year on embryonic stem-cell research, he said.

If the new proposition is rejected by voters, CIRM will begin closing its doors this winter and ongoing research may crash, said Dr. Larry Goldstein, director of the UC San Diego Stem Cell Program.

If these trials get killed because of lack of funding, there is no guarantee that we will get them back up and running again, even if they look really promising, Goldstein said. It will be hard to find financing for them.

Proposition 71 launched the beginning of embryonic stem-cell research and Proposition 14, despite the steep price tag, should continue that momentum, say proponents.

There is no dollar amount you can put on having a healthy child, said Alysia Vaccaro, Evangelinas mother. There is no price for that.

Prop 71, by the numbers:

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President Trump has benefitted from decades of medical research using human fetal tissue, and so have you.

When he got sick with the coronavirus in September, Trump's Regeneron antibody treatment had been developed with the use of HEK 293T cells, which have been a workhorse material on biomedical lab benches around the world, since they were first cultured from an embryonic kidney cell in the Netherlands in the early 1970s.

Even so, Trump and his administration have cracked down on new fetal tissue research being done today in the US dampening hopes the same kinds of cells that helped create his treatment may continue being used in new research, to pave the way toward future treatments and cures for millions of people.

The ban could have a crippling effect on the hunt for treatments for neurodegenerative diseases, and new drug therapies for cancers and HIV. It's also affecting the way scientists study viruses that cause disease in humans, a critical impairment during the coronavirus pandemic.

The truth is, there is no great alternative (yet) for human fetal tissue in medical research. (Humans, and their development, are kind of complicated.) So, for now, we're missing out on an unknown number of medical advances, as the raw materials for this research get discarded after miscarriages and abortions.

"Scientists, such as myself, think that it's better for all of that tissue to go to research, than to just destroy it," Professor Lawrence Goldstein, a neuroscientist at UC San Diego, who has used fetal tissue to study Alzheimer's in the past, said.

Here's why.

Dr. Scott Kitchen, associate professor of medicine and Director, UCLA CFAR/JCCC Humanized Mouse Core Laboratory, in the vivarium mice room at the UCLA campus in Los Angeles, California on November 15, 2019. Philip Cheung for The Washington Post via Getty Images

"Most drugs and most vaccines have, at some point in their movement towards the clinic, passed through a stage in which they've been either developed or tested using cell lines that came from human fetal tissue," said Dr. Mike McCune, an HIV researcher who, in the 1980s, developed the first mice engineered to study human diseases using fetal tissue.

In McCune's lab, fetal tissue has been used to test out drug treatments that have turned HIV from a death sentence into a livable, chronic disease. Today, many branches of medical research, treating everything from cancer, to spinal cord injuries, Alzheimer's, and organ transplants have all, in some way, benefitted from fetal tissue research.

One of the most basic ways that fetal tissue has been used is in the creation of prolific cell lines (like the ones Regeneron's used in its labs) which can be dispatched indefinitely to test out how well treatments or vaccines might work, before they go inside people.

Such cell lines are also sometimes used not just to test, but to create treatments. Take the advent of the polio vaccine, which has prevented millions of cases of paralysis, and saved hundreds of thousands of lives. That was once grown inside fetal cells, as were many other vaccines.

Fetal tissue is also used as a gold standard comparison tool. For example, in organ development, it's used to make sure that stem cells being developed into artificial organs are mimicking real, human, cells in the proper way.

Studying human fetal tissue also helps researchers better understand the reasons why birth defects arise, and glean insights into how these congenital issues may be better prevented in the future.

During the coronavirus pandemic, fetal tissue could be used to develop precise human immune system models which could then be used to quickly try out drugs, determining within weeks which might work, and which are duds.

Today, there is no reliably good alternative material to use for fetal tissue, the very makings of our humanness. Fetal cells are less specialized than fully-formed human cells, and as such, they are much more flexible tools than our own cells for using in the lab, and studying all kinds of diseases that only affect us.

Donating fetal tissue is a lot like organ donation. There are strict rules in place to ensure no exchange of money or favor occurs. Instead of being incinerated, then, that fetal tissue may be used in a lab.

"You have a family, a mother, or parents, who make the decision that they want something good to come out of this tragedy of losing, or terminating, a pregnancy," virologist Alexander Ploss, who does work on fetal stem cells at Princeton University, told Insider of fetal tissue donation. "We're basically now potentially restricting this option, and taking this option away."

Dr. Lindsey Baden, right, bumps elbows with COVID-19 vaccine trial participant Anthony Shivers at Brigham and Women's Hospital in Chestnut Hill, Massachusetts on October 8, 2020. Craig Walker/The Boston Globe via Getty Images

Fetal tissue was already given the Congressional thumbs up by a bipartisan group of lawmakers in 1993.

The vote in the Senate that year was near-unanimous: 93 to 4, with anti-abortion senators Mitch McConnell and Chuck Grassley both voting "yes". They acknowledged there are clear benefits to humanity in using this tissue, just as the National Institutes of Health did, as recently as 2018.

The National Catholic Bioethics Center has for years, likewise, agreed that there are benefits to using fetal cell lines and tissues.

The NCBC said as recently as May 2020 on its website that "one is morally free to use the vaccine, despite its historical association with abortion, if there is a proportionately serious reason for doing so."

"This is especially important for parents," the NCBC added, "who have a moral obligation to protect the life and health of their children, and those around them."

But on June 5, 2019, the Department of Health and Human Services stopped funding all new human fetal tissue research, effectively shutting down the last private labs (in California and Montana) that were using federal dollars for fetal tissue work.

"Many of the researchers who may be most affected by this policy change study pathways and processes associated with disease in infants and children," professor Carolyn Coyne, who studies viruses that affect fetal and neonatal health, wrote in the Washington Post at the time. "As such, the only certain consequence of the new policy is that it will impede medical discoveries that could advance new treatments to save the lives of infants, the very lives those in favor of this policy claim they are trying to protect."

Juan Duran-Gutierrez kisses his newborn baby girl Andrea for the first time in his home after bringing her home from the hospital, August 5, 2020. Duran-Gutierrez's wife and Andrea's mother, Aurora, died from COVID-19 in July. Elizabeth Flores/Star Tribune via Getty Images

The NIH can technically still fund work on fetal tissue outside its own walls, but the agency has been hamstrung by a new fetal tissue advisory board, largely comprised of members with strong antiabortion group ties. At a recent meeting, the group approved just one of 14 fetal tissue grant proposals up for review, The Washington Post reported. It was a grant to study whether an alternative to fetal tissue works as well.

"The administration has developed a policy that the evangelical and hardcore pro-life community wants, which is a complete ban on the use of any federal funds for new fetal tissue," Goldstein, who sat on the recent NIH committee, told Insider. "You know, they're okay with the old stuff."

Antiabortion groups have largely shrugged off the fact that Trump's coronavirus treatment benefitted from medical research on fetal tissue, decades ago.

Goldstein sees this as pure hypocrisy.

"The claim they're making is that, 'well, it was done a long time ago, so it's okay now,'" he said. "Well, you know, that's not really morally very consistent. You're going to block us from developing new therapies with fetal tissue, but you're going to be okay using the ones that are already here?"

Goldstein says there are three main reasons to continue using fetal stem cells: One, there's no evidence that this research incentivizes anyone to have an abortion. Two: "it's really valuable research" which has saved and improved countless lives. And three: "The alternative is throwing it in the trash," he said. "How is that a dignified use of the material?"

"I don't know if that's going to persuade anybody, but those are the factors I'd cite," he added.

Dr. Mustafa Gerek is vaccinated in volunteer in trials of a COVID-19 vaccine from China at Ankara City Hospital in Ankara, Turkey on October 13, 2020. Aytac Unal/Anadolu Agency via Getty Images

The coronavirus isn't the only area where scientists now have a blind spot.

"There's a whole bunch of genetic diseases that we don't understand very well, neuro-developmental disorders that we don't understand very well, for which actually having access to, let's say, human neuronal tissue, or whatever it may be, is absolutely critical," Ploss said.

"I'm not particularly optimistic that it's possible right now to obtain any serious funding, federal funding, for this kind of research," he said. "It's pretty much impossible right now to get any kind of funding for research that involves human fetal tissue."

But, he says, the stakes are so high that he'll still try, in the coming months. He, and all the other scientists Insider spoke to for this story are already worried about the US losing some of its competitive edge in biotech.

"The reason we are a world leader is because we have been innovative, we have rewarded innovation, and for the most part, the government has stayed out of the way, except funding high-quality research, that's been competitively reviewed," Goldstein said.

"We are always at risk of losing our advantage to an aggressive competitor, and I don't want to see that happen. I'm a loyal American, and I want to see us be the best."

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In summary

Proposition 14 asks voters to spend nearly $8 billion to continue the stem cell research program at a time when the coronavirus pandemic has decimated the state budget.

For the second time in 16 years, California voters will decide the fate of the states multi-billion dollar stem cell research program that established the state as a worldwide leader.

How the times have changed.

In November, as the pandemic drags on, Proposition 14 asks voters to spend nearly $8 billion to continue the program during a period when the research environment has significantly evolved and coronavirus has battered the states budget.

The bond measure would approve $5.5 billion in bonds to keep the states stem cell research agency running and grants flowing to California universities and companies.

At least $1.5 billion would be earmarked for brain and central nervous system diseases like Alzheimers and Parkinsons. The overall cost of the bonds and their interest totals about $7.8 billion, according to the state legislative analyst. The state would pay about $260 million annually for 30 years, or about 1 percent of Californias annual budget.

Proposition 14 is essentially a repeat with a bigger price tag and a few tweaks of Proposition 71, which California voters approved in 2004 after then-President George W. Bush prohibited, on religious grounds, all federal funding of any stem cell research using human embryos.

The bond measure would approve $5.5 billion in bonds to keep the states stem cell research agency running and grants flowing to California universities and companies.

That groundbreaking measure authorized $3 billion in state bonds to create the states stem cell research agency, the California Institute for Regenerative Medicine, and fund grants for research into treatments for Alzheimers disease, cancer, spinal cord injuries and other diseases.

The institute has nearly used up its original funding, so Prop. 71s author, real estate investor and attorney Robert N. Klein II, led a new effort to get Prop. 14 on the November ballot.

This time, embryonic stem cell research is in a much different place, with federal funding no longer blocked and more funding from the biotech industry.

Voters will want to consider what Californias previous investment in stem cell research has accomplished. Its a nuanced track record.

While many scientific experts agree that Prop 71 was a bold social innovation that successfully bolstered emerging stem cell research, some critics argue that the institutes grantmaking was plagued by conflicts of interest and did not live up to the promises of miracle cures that Prop. 71s supporters made years ago. Although the agency is funded with state money, its overseen by its own board and not by the California governor or lawmakers.

The agency had done a very good job of setting priorities for stem cell research, including research using human embryos, and doling out $300 million annually to build up California as a regenerative medicine powerhouse, according to a 2013 evaluation by the National Academies of Science, Engineering and Medicine.

But the report also found that because the institutes board is made up of scientists from universities and biotech firms likely to apply for grants, board members had almost unavoidable conflicts of interest.

Because human stem cells can develop into many types of cells, including blood, brain, nerve and muscle cells, scientists have long looked to them for potential treatments for currently incurable diseases and injuries. Researchers use two types of stem cells: embryonic stem cells, derived from unused human embryos created through in vitro fertilization, and adult stem cells, which are harder to work with but in some cases can be coaxed in a lab into behaving more like embryonic stem cells.

From the start, stem cell research has been ethically charged and politically controversial because human embryos are destroyed in some types of studies. Federal restrictions on the research have waxed and waned, depending on which political party holds power. While former President Bush restricted federal money for embryonic stem cell research, former President Obama removed those restrictions.

The Trump administration has restricted government research involving fetal tissue but not embryonic stem cells. However, anti-abortion lawmakers have called on the President to once again end federal funding for embryonic stem cell research.

California-funded research has led to one stem cell treatment for a form of Severe Combined Immunodeficiency known as the bubble baby disease. Children with the rare disease dont make enough of a key enzyme needed for a normal immune system. Without treatment, they can die from the disease if not kept in a protective environment. The U.S. Food and Drug Administration is now reviewing the treatment but has not yet approved it for widespread use.

Although many of the agencys early grants were for basic science, the institute also has supported 64 clinical trials of treatments for many types of cancer, sickle cell disease, spinal cord injuries, diabetes, kidney disease and amyotrophic lateral sclerosis, commonlyknown as Lou Gehrigs disease.

A June 2020 analysis by University of Southern California health policy researchers estimated that taxpayers initial $3 billion investment in the research institute helped create more than 50,000 jobs and generated $10 billion for the states economy.

Gov. Gavin Newsom has endorsed Proposition 14, and other supporters include the Regents of the University of California, the California Democratic Party, the Juvenile Diabetes Research Foundation, patient advocacy groups like the March of Dimes, and some local politicians and chambers of commerce.

Supporters have raised more than $8.5 million, including about $2 million from billionaire Dagmar Dolby, to pass the measure, according to California Secretary of State campaign finance reports.

The passage of Proposition 71 helped save my life, Sandra Dillon, a blood cancer patient, wrote in a San Diego Union-Tribune commentary supporting Proposition 14. She wrote that she had benefited from a drug developed with Institute-funded research that has been designated by the FDA as a breakthrough therapy.

It is unimaginable to think that Californians would vote to discontinue this amazing effort I dont know where I would be or what condition I would be in if it wasnt for the investment Californians made nearly two decades ago.

I think the agencys done good work, but this was never planned to be funded forever with debt.

Lawrence Goldstein, a UC San Diego professor of cellular and molecular medicine and stem cell researcher, said the grants were instrumental in furthering his research on treatments for Alzheimers disease and that Prop. 14 will help create new jobs. The agency has funded a great deal of very important stem cell medical research thats already produced terrific results and has the prospect of saving many more lives in the decade to come, he said.

Opponents include one member of the institutes board and a nonprofit that advocates for privacy in genetic research. They contend that the proposition seeks too much money and does not sufficiently address the conflicts of interest that cropped up after Prop. 71 was passed. They also note that private funding, including venture capital, for stem cell research has grown in recent years. Opponents had raised only $250 by late September, from a single contribution by the California Pro Life Council.

The editorial boards of some of Californias biggest newspapers also have opposed the measure, including the Los Angeles Times, the Orange County Register, the San Francisco Chronicle and the San Jose Mercury News/East Bay Times. The Fresno Bee, Modesto Bee, and San Luis Obispo Tribune newspaper editorial boards support Prop 14.

Jeff Sheehy, the only institute board member not to support Proposition 14, told CalMatters that the research environment has changed since voters initially approved state funding for stem cell research in 2004 and that California should prioritize other needs like education, health care, and housing.

I think the agencys done good work, but this was never planned to be funded forever with debt, Sheehy said. At this point the state cant afford it; were looking at a huge deficit.

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Advances in the stem cell therapy sector have been phenomenal over the years. Its assistance in curing humans of various diseases and disorders has generated expansive advancements. These advancements are not just limited to humans. Stem cell therapy has also acquired a prominent place in the veterinary sector.

The influence of animal stem cell therapy for the treatment of various animals for diverse diseases and disorders is growing rapidly. Therefore, this factor may help the global animal stem cell therapy market to generate exponential growth across the forecast period of 2019-2029. Stem cells help in the replacement of neurons affected by stroke, Parkinsons disease, spinal cord injury, Alzheimers disease, and others.

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This animal stem cell therapy market report has extensive information on various aspects associated with bringing growth. Important factors such as emerging trends, mergers and acquisitions, and the regional scenario of the animal stem cell therapy market have been analyzed and included in the report. The stakeholders can derive a treasure of information from this report. This report also includes a scrutinized take on the COVID-19 impact on the animal stem cell therapy market.

Animal Stem Cell Therapy Market: Competitive Prospects

The competitive landscape of the animal stem cell therapy market can be described as mildly fragmented. With a considerable chunk of players, the animal stem cell therapy market is surrounded by substantial competition. Research and development activities form an important part of the growth landscape because they help gain novel insights.

Activities such as mergers, acquisitions, joint ventures, collaborations, and partnerships form the foundation of the growth of the animal stem cell therapy market. These activities help manufacturers to gain influence and eventually help in increasing the growth rate of the animal stem cell therapy market. Prominent participants in the animal stem cell therapy market are Magellan Stem Cells, Medivet Biologics LLC, Kintaro Cells Power, U.S. Stem Cell, Inc., Celavet Inc., VETSTEM BIOPHARMA, and VetCell Therapeutics.

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Animal Stem Cell Therapy Market: Key Trends

Infections are scaling up among animals at a rapid rate. The alarming increase is proving fatal for many animals. Therefore, to avoid such incidences and treat existing diseases and disorders, animal stem cell therapy is being applied seamlessly. Hence, this aspect may bring great growth opportunities for the animal stem cell therapy market.

Developments have been observed across the animal stem cell therapy market for long. Autologous adipose-derived mesenchymal stem cells are gaining traction for successfully resolving a range of issues in animals. These stem cells help in treating ligament and tendon injuries to a certain extent. The strengthening influence of this stem cell type in companion animals is also proving to be a prominent growth prospect for the animal stem cell therapy market.

Recent research has also found that stem cell-derived CC exosomes showed improved recovery from myocardial infarction (MI) among pigs. Such developments assure promising growth for the animal stem cell therapy market.

Animal Stem Cell Therapy Market: Regional Analysis

The animal stem cell therapy market is spread across North America, Latin America, the Middle East and Africa, Europe, and Asia Pacific. The animal stem cell therapy market may derive significant growth from North America. The escalating awareness regarding animal stem cell therapy may attract profound growth. Strengthening research and development activities in the region regarding animal stem cell therapy is further expanding the growth prospects.

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Engineers at the University of California, Davis, will lead a consortium of universities, biomedical startups and nonprofit organizations to develop interventions for spinal cord injuries that can be applied within days of injury to improve long-term outcomes.

Karen Moxon, professor of biomedical engineering at UC Davis, will lead the five-year, $36 million contract as part of the Defense Advanced Research Project Agency, or DARPA, Bridging the Gap Plus Program. A primary goal is to develop technologies to stabilize a patients hemodynamic response, which includes blood flow and blood pressure, within days of injury.

Because large swings in blood pressure are common following spinal cord injuries, stabilizing hemodynamics within days of injury will improve functional recovery. The team will take advantage of stabilized hemodynamics to optimize delivery of neural stem cells using personalized 3D printed scaffolds within two weeks of injury to regenerate lost connections within the injured spinal cord.

Spinal cord injury is a complex condition that causes partial or complete loss of function below the location of injury, Moxon said. We will develop systems for real-time biomarker monitoring and intervention to stabilize and rebuild neural communications pathways between the brain and spinal cord. As a result of our efforts, clinicians will be able to collect previously unavailable diagnostic information for automated or clinician-directed interventions. Our goal is to translate these technologies to humans within the five-year award period.

The international team includes 12 institutions: UC Davis, UC San Diego, UC San Francisco, the University of British Columbia, the University of Calgary and the cole Polytechnique Fdrale de Lausanne (EPFL, Switzerland); biotech startups Pathonix Innovation Inc. of Vancouver, GTX Medical (Lausanne, Switzerland), and Teliatry (Richardson, Texas); nonprofit institutions the Wyss Center for Bio and Neuroengineering (Geneva, Switzerland) and Battelle Memorial Institute (Columbus, Ohio); and a regulatory consultant firm, NetValue BioConsulting Inc., Toronto.

Moxon and her team at UC Davis including Zhaodan Kong, associate professor in the Department of Mechanical and Aerospace Engineering, and Professor Kiarash Shahlaie and Assistant Professor Julius Ebinu, neurosurgeons in the UC Davis School of Medicine will take the lead on assessing the impact of these interventions on the brain to maximize the restoration of both motor and sensory functions. This part of the project will be conducted at the California National Primate Research Center.

We are extremely pleased that the California National Primate Research Center will host the nonhuman primate research arm of this extraordinary effort to restore function following spinal cord injury, said center director John Morrison, professor of neurology at UC Davis.

Part of the effort will also aim to improve functional recovery, using neural stem cell and bioengineering scaffold technology developed by professors Mark Tuszynski, Paul Lu, Ephron Rosenzweig and Jacob Koffler, all faculty in the Department of Neurosciences at UCSD. Their stem cell and scaffold technology will be combined with neural electrical stimulation technology (neuromodulation) developed by Gregoire Courtine at EPFL. The team hopes to successfully combine this cell and engineering technology to promote nerve regeneration that bridges the injury site.

Moxons lab at UC Davis, in collaboration with a teamat the Wyss Center for Bio and Neuroengineering led by Tracy Laabs, will develop cortical stimulation protocols to enhance sensory feedback to the brain and aid in motor control. The team will take advantage of Wysss ABILITYsystem that wirelessly records signals from individual neurons in the brain and will further develop it to include closed-loop cortical stimulation, which employs a sensor to record signals, for improved motor function.

The multi-institution team will focus on advancing three main technologies:

Together, these technologies will integrate into a system-of-systems that monitors the information from sensors and stimulators to allow clinicians to monitor patients progress. At the same time, the team will be able to identify the optimal time to transplant the neural stem cells and 3D scaffold in this critical time period after injury.

It is exciting to lead this talented team of international scientists and to be in a position to effect real change for people who sustain a spinal cord injury, Moxon said. Its this type of team science between academia and industry that makes clinical breakthroughs possible in short time periods.

Development of the proposal for the award was facilitated by the UC Davis Office of Researchs Interdisciplinary Research Support team and Gabriela Lee, project manager. This project is part of a larger effort at UC Davis led by Moxon, Professor Sanjay Joshi in the Department of Mechanical and Aerospace Engineering, and Professor Carolynn Patten in the School of Medicine and College of Biological Sciences to develop a neuroengineering program that aims to restore, augment and extend human capacity to benefit society.

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Olivia Allen-Price [00:01:55] OK, so what exactly does this bond fund?

Danielle Venton [00:01:59] This would fund $5.5 billion in stem cell research and treatments in California. Some of the diseases that stem cell research is seeking to cure or treat include cancer, Alzheimer's disease, diabetes, spinal cord injuries, blindness, and even COVID-19. I spoke recently with a guy named Jake Javier. He supports this bond initiative because he knows firsthand how life changing stem cell research can be.

Jake Javier [00:02:25] I am in my last year at Cal Poly.

Danielle Venton [00:02:28] So, Jake grew up locally in Danville and was just graduating high school when he suffered a life altering injury.

Jake Javier [00:02:35] On the last day of high school, I drove in to a pool and hit my head on the bottom and broke my neck and was immediately paralyzed.

Danielle Venton [00:02:47] He says his injury was complete, with very little hope of recovery. But a doctor at Stanford reached out to Jake and his family and said, you can be part of this clinical trial where we, with a one time surgery, will inject stem cells into the damaged area and you may possibly see some benefits.

Danielle Venton [00:03:07] Now, Jake is still injured.

Jake Javier [00:03:09] I'm a quadriplegic. I use a wheelchair.

Danielle Venton [00:03:11] But he says after the surgery, he noticed more movement in his arms, in his hands.

Jake Javier [00:03:17] So, I mean, with my injury, I'm at a level where I would normally not have any function at all in my hands and very, very little function like in my triceps and things like that. Muscles that are really important for functionality and, you know, being able to get through day to day activities that could help me push myself around more, help me transfer in and out of my chair independently. And then also, I notice, you know, I got some some finger movement. It doesn't seem like much, but even that little movement has helped me so much with picking things up and things like that. So it was really, I was really blessed to see that happen.

Danielle Venton [00:03:51] So he doesn't know how much of his recovery is due to the stem cells. How much is natural, or how much is due to physical therapy. But today he's able to live independently, to go to college and he wants to pursue a career in medicine. And he is a big believer in stem cell research, regenerative medicine, and is really hoping that California voters will support this proposition.

Olivia Allen-Price [00:04:20] Now, what exactly are stem cells and how do they work, I guess?

Danielle Venton [00:04:25] Yeah, stem cells are types of cells that can be turned into any type of specialized cell. Scientists have known about them since the eighteen hundreds, but it wasn't until the late 90s that researchers developed a method to derive them from human embryos and grow them in a laboratory. And then people really began to get excited about their potential for medicine. Now these cells came from unused embryos created for in vitro fertilization, and they were donated with informed consent. But many anti-abortion groups felt that using the cells were tantamount to taking a human life. So in 2001, then President George W. Bush banned federal funding for any research using newly created stem cell lines.

Olivia Allen-Price [00:05:09] OK. And how does that get us now to bonds in California?

Danielle Venton [00:05:13] Well, Californians wanted to circumvent these federal restrictions, and in 2004 voted for a bond that gave the state $3 billion to create a research agency called the California Institute of Regenerative Medicine, or CIRM. There was a lot of public support for it. And it just felt like these wonderful cures could be right around the corner. Celebrities like Michael J. Fox appeared in TV commercials.

Michael J. Fox TV commercial [00:05:36] My most important role lately is as an advocate for patients, and for finding new cures for diseases. That's why I'm asking you to vote yes on Proposition 71, Stem Cell Research Initiative.

Danielle Venton [00:05:48] And the money for that research, that $3 billion, has now run out. And to continue their work, the stem cell advocacy group, Americans for Cures, is asking voters for more money.

Olivia Allen-Price [00:06:00] So we're basically voting on whether we want to refill the stem cell research piggy bank here.

Danielle Venton [00:06:05] Yeah, exactly. Some question if the state can afford this at this time when budgets are going to be so tight. Others have been disappointed by the slow pace of cures coming out of the field. Now, there are people who credit this research, such as Jake, with improving or restoring their health or the health of their loved ones. Or maybe they hope that one day it will, and they would balk at the idea that this is not worthy research. They point to achievements that the agency has funded. That includes effectively a cure for bubble baby disease. This is when someone is born without a functioning immune system. That mutation can now be corrected with genetically modified stem cells. And recently, just within the last year or so, the FDA approved two new treatments for blood cancer, developed with CIRM support. These achievements are what the agency points to when they're criticized for not having accomplished more. And they say the process of scientific discovery is long and unpredictable.

Olivia Allen-Price [00:07:04] Now, wasn't that Bush-era ban on stem cell research that you were talking about earlier wasn't that overturned?

Danielle Venton [00:07:11] Yes, that was overturned by President Obama. However, there are current members of Congress who are lobbying President Trump to ban the research again. And if that happens, then California would be the only major player in stemcell research once again in the United States.

Olivia Allen-Price [00:07:30] All right, so who is supporting Prop 14?

Danielle Venton [00:07:32] Governor Gavin Newsom, for one. Many patient advocacy organizations and medical and research institutions, including the California Board of Regents. These people don't want to see the pace of this research slow. They want it to accelerate. The political action committee supporting this proposition is reporting more than six million dollars in contributions.

Olivia Allen-Price [00:07:53] All right. And what about the opposition? Who's against it?

Danielle Venton [00:07:55] Well, so far, there's no organized, funded opposition. There have been several newspaper editorials coming out against it, including locally, the Mercury News and the Santa Rosa Press Democrat. They basically say state bonds aren't the way to fund research and the situation isn't like it was in 2004 and that the institute should now seek other sources of funding and move forward as a nonprofit.

Olivia Allen-Price [00:08:19] All right, Danielle. Well, thanks, as always for your help.

Danielle Venton [00:08:21] My pleasure. Thanks.

Olivia Allen-Price [00:08:28] In a nutshell, a vote yes on Proposition 14 says you think Californians should give $5.5 billion to the state's stem cell research institute. That money will be raised by selling bonds, which the state would pay back, with interest, out ofthe general fund over the next 30 years. A vote no means you think we shouldn't spend public money on this research.

Olivia Allen-Price [00:08:54] That's it on Proposition 14. We'll be back tomorrow with an episode on Prop 15. And oh, it is a doozy. Commercial property tax! A partial rollback of one of California's most controversial propositions! It's going to be fire. In the meantime, you can find more of KQED election coverage at KQED.org/elections. Two reminders on the way out: October 19th is the last day to register to vote and mail in ballots must be postmarked on or before November 3rd.

Olivia Allen-Price [00:09:28] Bay Curious is made in San Francisco at member supported KQED. I'm Olivia Allen-Price. See you tomorrow.

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What You Need to Know About Prop 14, The Stem Cell Research Bond (Transcript) - KQED

Spinal Cord Stem Cells Comments Off on What You Need to Know About Prop 14, The Stem Cell Research Bond (Transcript) – KQED | October 2nd, 2020

Researchers from Critical Analytics for Manufacturing Personalized-Medicine (CAMP), an interdisciplinary research group at Singapore-MIT Alliance for Research and Technology (SMART), MITs research enterprise in Singapore, have been awarded Intra-CREATE grants from the National Research Foundation (NRF) Singapore to help support research on retinal biometrics for glaucoma progression and neural cell implantation therapy for spinal cord injuries. The grants are part of the NRFs initiative to bring together researchers from Campus for Research Excellence And Technological Enterprise (CREATE) partner institutions, in order to achieve greater impact from collaborative research efforts.

SMART CAMP was formed in 2019 to focus on ways to produce living cells as medicine delivered to humans to treat a range of illnesses and medical conditions, including tissue degenerative diseases, cancer, and autoimmune disorders.

Singapores well-established biopharmaceutical ecosystem brings with it a thriving research ecosystem that is supported by skilled talents and strong manufacturing capabilities. We are excited to collaborate with our partners in Singapore, bringing together an interdisciplinary group of experts from MIT and Singapore, for new research areas at SMART. In addition to our existing research on our three flagship projects, we hope to develop breakthroughs in manufacturing other cell therapy platforms that will enable better medical treatments and outcomes for society, says Krystyn Van Vliet, co-lead principal investigator at SMART CAMP, professor of materials science and engineering, and associate provost at MIT.

Understanding glaucoma progression for better-targeted treatments

Hosted by SMART CAMP, the first research project, Retinal Analytics via Machine learning aiding Physics (RAMP), brings together an interdisciplinary group of ophthalmologists, data scientists, and optical scientists from SMART, Singapore Eye Research Institute (SERI), Agency for Science, Technology and Research (A*STAR), Duke-NUS Medical School, MIT, and National University of Singapore (NUS). The team will seek to establish first principles-founded and statistically confident models of glaucoma progression in patients. Through retinal biomechanics, the models will enable rapid and reliable forecast of the rate and trajectory of glaucoma progression, leading to better-targeted treatments.

Glaucoma, an eye condition often caused by stress-induced damage over time at the optic nerve head, accounts for 5.1 million of the estimated 38 million blind in the world and 40 percent of blindness in Singapore. Currently, health practitioners face challenges forecasting glaucoma progression and its treatment strategies due to the lack of research and technology that accurately establish the relationship between its properties, such as the elasticity of the retina and optic nerve heads, blood flow, intraocular pressure and, ultimately, damage to the optic nerve head.

The research is co-led by George Barbastathis, principal investigator at SMART CAMP and professor of mechanical engineering at MIT, and Aung Tin, executive director at SERI and professor at the Department of Ophthalmology at NUS. The team includes CAMP principal investigators Nicholas Fang, also a professor of mechanical engineering at MIT; Lisa Tucker-Kellogg, assistant professor with the Cancer and Stem Biology program at Duke-NUS; and Hanry Yu, professor of physiology with the Yong Loo Lin School of Medicine, NUS and CAMPs co-lead principal investigator.

We look forward to leveraging the ideas fostered in SMART CAMP to build data analytics and optical imaging capabilities for this pressing medical challenge of glaucoma prediction, says Barbastathis.

Cell transplantation to treat irreparable spinal cord injury

Engineering Scaffold-Mediated Neural Cell Therapy for Spinal Cord Injury Treatment (ScaNCellS), the second research project, gathers an interdisciplinary group of engineers, cell biologists, and clinician scientists from SMART, Nanyang Technological University (NTU), NUS, IMCB A*STAR, A*STAR, French National Centre for Scientific Research (CNRS), the University of Cambridge, and MIT. The team will seek to design a combined scaffold and neural cell implantation therapy for spinal cord injury treatment that is safe, efficacious, and reproducible, paving the way forward for similar neural cell therapies for other neurological disorders. The project, an intersection of engineering and health, will achieve its goals through an enhanced biological understanding of the regeneration process of nerve tissue and optimized engineering methods to prepare cells and biomaterials for treatment.

Spinal cord injury (SCI), affecting between 250,000 and 500,000 people yearly, is expected to incur higher societal costs as compared to other common conditions such as dementia, multiple sclerosis, and cerebral palsy. SCI can lead to temporary or permanent changes in spinal cord function, including numbness or paralysis. Currently, even with the best possible treatment, the injury generally results in some incurable impairment.

The research is co-led by Chew Sing Yian, principal investigator at SMART CAMP and associate professor of the School of Chemical and Biomedical Engineering and Lee Kong Chian School of Medicine at NTU, and Laurent David, professor at University of Lyon (France) and leader of the Polymers for Life Sciences group at CNRS Polymer Engineering Laboratory. The team includes CAMP principal investigators Ai Ye from Singapore University of Technology and Design; Jongyoon Han and Zhao Xuanhe, both professors at MIT; as well as Shi-Yan Ng and Jonathan Loh from Institute of Molecular and Cell Biology, A*STAR.

Chew says, Our earlier SMART and NTU scientific collaborations on progenitor cells in the central nervous system are now being extended to cell therapy translation. This helps us address SCI in a new way, and connect to the methods of quality analysis for cells developed in SMART CAMP.

Cell therapy, one of the fastest-growing areas of research, will provide patients with access to more options that will prevent and treat illnesses, some of which are currently incurable. Glaucoma and spinal cord injuries affect many. Our research will seek to plug current gaps and deliver valuable impact to cell therapy research and medical treatments for both conditions. With a good foundation to work on, we will be able to pave the way for future exciting research for further breakthroughs that will benefit the health-care industry and society, says Hanry Yu, co-lead principal investigator at SMART CAMP, professor of physiology with the Yong Loo Lin School of Medicine, NUS, and group leader of the Institute of Bioengineering and Nanotechnology at A*STAR.

The grants for both projects will commence on Oct. 1, with RAMP expected to run until Sept. 30, 2022, and ScaNCellS expected to run until Sept. 30, 2023.

SMART was. established by the MIT in partnership with the NRF in 2007. SMART is the first entity in the CREATE developed by NRF. SMART serves as an intellectual and innovation hub for research interactions between MIT and Singapore, undertaking cutting-edge research projects in areas of interest to both Singapore and MIT. SMART currently comprises an Innovation Centre and five interdisciplinary research groups (IRGs): Antimicrobial Resistance, CAMP, Disruptive and Sustainable Technologies for Agricultural Precision, Future Urban Mobility, and Low Energy Electronic Systems.

CAMP is a SMART IRG launched in June 2019. It focuses on better ways to produce living cells as medicine, or cellular therapies, to provide more patients access to promising and approved therapies. The investigators at CAMP address two key bottlenecks facing the production of a range of potential cell therapies: critical quality attributes (CQA) and process analytic technologies (PAT). Leveraging deep collaborations within Singapore and MIT in the United States, CAMP invents and demonstrates CQA/PAT capabilities from stem to immune cells. Its work addresses ailments ranging from cancer to tissue degeneration, targeting adherent and suspended cells, with and without genetic engineering.

CAMP is the R&D core of a comprehensive national effort on cell therapy manufacturing in Singapore.

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SMART researchers receive Intra-CREATE grant for personalized medicine and cell therapy - MIT News

Spinal Cord Stem Cells Comments Off on SMART researchers receive Intra-CREATE grant for personalized medicine and cell therapy – MIT News | October 2nd, 2020

New York, Sept. 29, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Global Nerve Repair and Regeneration Devices Industry" - https://www.reportlinker.com/p05957490/?utm_source=GNW Nerves constitute the most significant cable systems in the human body, performing the crucial job of carrying messages and information to brain and also to other parts of body. Whenever such critical nerves are injured, problems arise in muscles leading to sensation loss. Major types of nerve injuries include Neuropraxia, the physiologic blocking of nerve; Axonotmesis, the anatomic disruption of axon with slight disruption of connective tissue; and Neurotmesis, the anatomic disruption of connective tissue and nerve fibers.These injuries could result in trauma or more serious neurodegenerative diseases such as Parkinson`s disease, Alzheimer`s disease, multiple system atrophy, multiple sclerosis, and amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig`s disease).Alzheimer`s, Parkinson`s, Amyotrophic Lateral Sclerosis and multiple sclerosis are diseases that cause injury to the complex, delicate structures of the nervous system.Till date spinal cord injury and peripheral nerve damage are often permanent and incapacitating.

Innovative strategies are required for a shift in the paradigm and advanced treatment of these neurological injuries.But the question as to whether adult neurogenesis isrealstill remains unanswered with several contentious research studies still underway with no definitive answer to this century-long debate. Regrowth or repair of nervous tissues and cells involves generation of new neurons, glia, axons, myelin, or synapses.Gene Therapy is attracting immense research investments for its promise in promoting nerve regeneration and intraneural revascularization is being studied for its role in peripheral nerve regeneration.Newer studies are however dampening hopes by stating that adults produce no new cells in the hippocampus. Nevertheless, hopes of regeneration arecreating lucrative commercial opportunities as the pressure builds for newer and more effective treatment for neurological diseases.As the world awaits for a paradigm-shift in the treatment of neurological injury, neurostimulation and neuromodulation devices and biomaterials remains a massive multibilliondollar market worldwide. Neurostimulation and neuromodulation devices are currently available solutions to treat a variety of nerve injuries including peripheral nerve injuries. Neurostimulation and neuromodulation methods involve use of specially designed devices to transmit electrical impulses for controlling activity of the central nervous system and the brain.Internal neurostimulation and neuromodulation devices are growing in popularity for their significantly lower risk for post-surgical complications and shorter hospital stays. These include deep brain stimulation (DBS)for Parkinson`s, epilepsy and depression; spinal cord stimulation (SCS) for pain management and spasticity; gastric electrical stimulation (GES) for obesity and gastroparesis; vagus nerve stimulation (VNS) for depression and epilepsy; and sacral nerve stimulation (SNS) for constipation and urinary incontinence disorders.External neurostimulation devices, on the other hand, comprise transcutaneous vagus nerve stimulation (TVNS) for autism, depression, anxiety and age related disorders; transcutaneous electrical nerve stimulation (TENS)for chronic neuropathic pain and fibromyalgia disorders; transcranial magnetic stimulation (TMS)for depression and ADHD; and respiratory electrical stimulation (RES) for improving the respiratory function after spinal cord injury.

Read the full report: https://www.reportlinker.com/p05957490/?utm_source=GNW

I. INTRODUCTION, METHODOLOGY & REPORT SCOPE

II. EXECUTIVE SUMMARY

1. GLOBAL MARKET OVERVIEW Nerve Repair and Regeneration Market Set for a Rapid Growth Neurostimulation and Neuromodulation Devices: Largest Product Segment Biomaterials to Exhibit Rapid Growth Nerve Repair and Regeneration Market by Application US and Europe Dominate the Market, Asia-Pacific to Register the Fastest Growth

2. FOCUS ON SELECT PLAYERS Abbott Laboratories, Inc. (USA) AxoGen, Inc. (USA) Boston Scientific Corporation (USA) Integra LifeSciences Corporation (USA) LivaNova, PLC (UK) Medtronic plc (USA) NeuroPace, Inc. (USA) Nevro Corporation.(USA) Orthomed S.A.S. (France) Polyganics B.V. (The Netherlands) Stryker Corporation (U.S.) Synapse Biomedical Inc. (U.S.)

3. MARKET TRENDS & DRIVERS High Incidence of Brain Disorders and Nerve Injuries: Primary Market Driver Annual Incidence of Adult-Onset Neurologic Disorders in the US Symptomatic Epilepsy Incidence by Type (2019): Percentage Share Breakdown of Congenital, Degenerative, Infective, Neoplastic, Trauma, and Vascular Epilepsy Global Alzheimers Prevalence by Age Group Diagnosed Prevalence Cases of Parkinson?s Disease Across Select Countries Classification of Nerve Injuries Recent Developments in Spinal Cord Injury Treatment Rising Geriatric Population and Subsequent Growth in Prevalence Of Neurological Disorders Global Population Statistics for the 65+ Age Group in Million by Geographic Region for the Years 2019, 2025, 2035 and 2050 Intensified Research Activity Across Various Neural Disciplines Induces Additional Optimism Stem Cell Therapy: A Promising Avenue for Nerve Repair and Regeneration New Biomaterials Pave the Way for Innovative Neurodegeneration Therapies Role of Nerve Conduits in the Treatment of Peripheral Nerve Injury Innovative Nerve Conduits from Stryker Technological Advancements and Product Innovations - A Key Growth Driver Neurostimulation Allows Paralyzed People to Regain Leg Movement Neurostimulator to Treat Neurological Conditions Micro-Implantable Solution for Neurostimulation Parasym? Device for Neurostimulation Boston Scientific?s Spinal Cord Stimulation Improves Quality of Life Intellis? Platform Presents Smallest Implantable Neurostimulator Innovation in Deep Brain Stimulation for Parkinson?s Disease Innovations in Spinal Cord Stimulation for Pain Smart Neuromodulation: The Combination of AI and Neuromodulation Technologies New Dynamic Lead Interface Design for Neurostimulator Devices Wireless SCS Neuromodulation Therapy: An Alternative to Traditional SCS System Select Recent Approvals of Neuro-stimulation and Neuromodulation Devices Select Launches in Spinal Cord Stimulation (SCS) Market Select Launches in Deep Brain Stimulation (DBS) Market Select Neurostimulation Devices in Clinical Trials Select Neuromodulation Devices in Clinical Trials

4. GLOBAL MARKET PERSPECTIVE Table 1: World Current & Future Analysis for Nerve Repair and Regeneration Devices by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2020 through 2027

Table 2: World Historic Review for Nerve Repair and Regeneration Devices by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2012 through 2019

Table 3: World 15-Year Perspective for Nerve Repair and Regeneration Devices by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets for Years 2012, 2020 & 2027

Table 4: World Current & Future Analysis for Neurostimulation & Neuromodulation Devices by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2020 through 2027

Table 5: World Historic Review for Neurostimulation & Neuromodulation Devices by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2012 through 2019

Table 6: World 15-Year Perspective for Neurostimulation & Neuromodulation Devices by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2012, 2020 & 2027

Table 7: World Current & Future Analysis for Biomaterials by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2020 through 2027

Table 8: World Historic Review for Biomaterials by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2012 through 2019

Table 9: World 15-Year Perspective for Biomaterials by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2012, 2020 & 2027

Table 10: World Current & Future Analysis for Neurostimulation & Neuromodulation Surgeries by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2020 through 2027

Table 11: World Historic Review for Neurostimulation & Neuromodulation Surgeries by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2012 through 2019

Table 12: World 15-Year Perspective for Neurostimulation & Neuromodulation Surgeries by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2012, 2020 & 2027

Table 13: World Current & Future Analysis for Neurorrhaphy by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2020 through 2027

Table 14: World Historic Review for Neurorrhaphy by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2012 through 2019

Table 15: World 15-Year Perspective for Neurorrhaphy by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2012, 2020 & 2027

Table 16: World Current & Future Analysis for Nerve Grafting by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2020 through 2027

Table 17: World Historic Review for Nerve Grafting by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2012 through 2019

Table 18: World 15-Year Perspective for Nerve Grafting by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2012, 2020 & 2027

Table 19: World Current & Future Analysis for Stem Cell Therapy by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2020 through 2027

Table 20: World Historic Review for Stem Cell Therapy by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2012 through 2019

Table 21: World 15-Year Perspective for Stem Cell Therapy by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2012, 2020 & 2027

Table 22: World Current & Future Analysis for Hospitals & Clinics by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2020 through 2027

Table 23: World Historic Review for Hospitals & Clinics by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2012 through 2019

Table 24: World 15-Year Perspective for Hospitals & Clinics by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2012, 2020 & 2027

Table 25: World Current & Future Analysis for Ambulatory Surgery Centers by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2020 through 2027

Table 26: World Historic Review for Ambulatory Surgery Centers by Geographic Region - USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2012 through 2019

Table 27: World 15-Year Perspective for Ambulatory Surgery Centers by Geographic Region - Percentage Breakdown of Value Sales for USA, Canada, Japan, China, Europe, Asia-Pacific, Latin America, Middle East and Africa for Years 2012, 2020 & 2027

III. MARKET ANALYSIS

GEOGRAPHIC MARKET ANALYSIS

UNITED STATES Table 28: USA Current & Future Analysis for Nerve Repair and Regeneration Devices by Product - Neurostimulation & Neuromodulation Devices and Biomaterials - Independent Analysis of Annual Sales in US$ Billion for the Years 2020 through 2027

Table 29: USA Historic Review for Nerve Repair and Regeneration Devices by Product - Neurostimulation & Neuromodulation Devices and Biomaterials Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2012 through 2019

Table 30: USA 15-Year Perspective for Nerve Repair and Regeneration Devices by Product - Percentage Breakdown of Value Sales for Neurostimulation & Neuromodulation Devices and Biomaterials for the Years 2012, 2020 & 2027

Table 31: USA Current & Future Analysis for Nerve Repair and Regeneration Devices by Application - Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy - Independent Analysis of Annual Sales in US$ Billion for the Years 2020 through 2027

Table 32: USA Historic Review for Nerve Repair and Regeneration Devices by Application - Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2012 through 2019

Table 33: USA 15-Year Perspective for Nerve Repair and Regeneration Devices by Application - Percentage Breakdown of Value Sales for Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy for the Years 2012, 2020 & 2027

Table 34: USA Current & Future Analysis for Nerve Repair and Regeneration Devices by End-Use - Hospitals & Clinics and Ambulatory Surgery Centers - Independent Analysis of Annual Sales in US$ Billion for the Years 2020 through 2027

Table 35: USA Historic Review for Nerve Repair and Regeneration Devices by End-Use - Hospitals & Clinics and Ambulatory Surgery Centers Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2012 through 2019

Table 36: USA 15-Year Perspective for Nerve Repair and Regeneration Devices by End-Use - Percentage Breakdown of Value Sales for Hospitals & Clinics and Ambulatory Surgery Centers for the Years 2012, 2020 & 2027

CANADA Table 37: Canada Current & Future Analysis for Nerve Repair and Regeneration Devices by Product - Neurostimulation & Neuromodulation Devices and Biomaterials - Independent Analysis of Annual Sales in US$ Billion for the Years 2020 through 2027

Table 38: Canada Historic Review for Nerve Repair and Regeneration Devices by Product - Neurostimulation & Neuromodulation Devices and Biomaterials Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2012 through 2019

Table 39: Canada 15-Year Perspective for Nerve Repair and Regeneration Devices by Product - Percentage Breakdown of Value Sales for Neurostimulation & Neuromodulation Devices and Biomaterials for the Years 2012, 2020 & 2027

Table 40: Canada Current & Future Analysis for Nerve Repair and Regeneration Devices by Application - Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy - Independent Analysis of Annual Sales in US$ Billion for the Years 2020 through 2027

Table 41: Canada Historic Review for Nerve Repair and Regeneration Devices by Application - Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2012 through 2019

Table 42: Canada 15-Year Perspective for Nerve Repair and Regeneration Devices by Application - Percentage Breakdown of Value Sales for Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy for the Years 2012, 2020 & 2027

Table 43: Canada Current & Future Analysis for Nerve Repair and Regeneration Devices by End-Use - Hospitals & Clinics and Ambulatory Surgery Centers - Independent Analysis of Annual Sales in US$ Billion for the Years 2020 through 2027

Table 44: Canada Historic Review for Nerve Repair and Regeneration Devices by End-Use - Hospitals & Clinics and Ambulatory Surgery Centers Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2012 through 2019

Table 45: Canada 15-Year Perspective for Nerve Repair and Regeneration Devices by End-Use - Percentage Breakdown of Value Sales for Hospitals & Clinics and Ambulatory Surgery Centers for the Years 2012, 2020 & 2027

JAPAN Table 46: Japan Current & Future Analysis for Nerve Repair and Regeneration Devices by Product - Neurostimulation & Neuromodulation Devices and Biomaterials - Independent Analysis of Annual Sales in US$ Billion for the Years 2020 through 2027

Table 47: Japan Historic Review for Nerve Repair and Regeneration Devices by Product - Neurostimulation & Neuromodulation Devices and Biomaterials Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2012 through 2019

Table 48: Japan 15-Year Perspective for Nerve Repair and Regeneration Devices by Product - Percentage Breakdown of Value Sales for Neurostimulation & Neuromodulation Devices and Biomaterials for the Years 2012, 2020 & 2027

Table 49: Japan Current & Future Analysis for Nerve Repair and Regeneration Devices by Application - Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy - Independent Analysis of Annual Sales in US$ Billion for the Years 2020 through 2027

Table 50: Japan Historic Review for Nerve Repair and Regeneration Devices by Application - Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2012 through 2019

Table 51: Japan 15-Year Perspective for Nerve Repair and Regeneration Devices by Application - Percentage Breakdown of Value Sales for Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy for the Years 2012, 2020 & 2027

Table 52: Japan Current & Future Analysis for Nerve Repair and Regeneration Devices by End-Use - Hospitals & Clinics and Ambulatory Surgery Centers - Independent Analysis of Annual Sales in US$ Billion for the Years 2020 through 2027

Table 53: Japan Historic Review for Nerve Repair and Regeneration Devices by End-Use - Hospitals & Clinics and Ambulatory Surgery Centers Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2012 through 2019

Table 54: Japan 15-Year Perspective for Nerve Repair and Regeneration Devices by End-Use - Percentage Breakdown of Value Sales for Hospitals & Clinics and Ambulatory Surgery Centers for the Years 2012, 2020 & 2027

CHINA Table 55: China Current & Future Analysis for Nerve Repair and Regeneration Devices by Product - Neurostimulation & Neuromodulation Devices and Biomaterials - Independent Analysis of Annual Sales in US$ Billion for the Years 2020 through 2027

Table 56: China Historic Review for Nerve Repair and Regeneration Devices by Product - Neurostimulation & Neuromodulation Devices and Biomaterials Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2012 through 2019

Table 57: China 15-Year Perspective for Nerve Repair and Regeneration Devices by Product - Percentage Breakdown of Value Sales for Neurostimulation & Neuromodulation Devices and Biomaterials for the Years 2012, 2020 & 2027

Table 58: China Current & Future Analysis for Nerve Repair and Regeneration Devices by Application - Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy - Independent Analysis of Annual Sales in US$ Billion for the Years 2020 through 2027

Table 59: China Historic Review for Nerve Repair and Regeneration Devices by Application - Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2012 through 2019

Table 60: China 15-Year Perspective for Nerve Repair and Regeneration Devices by Application - Percentage Breakdown of Value Sales for Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy for the Years 2012, 2020 & 2027

Table 61: China Current & Future Analysis for Nerve Repair and Regeneration Devices by End-Use - Hospitals & Clinics and Ambulatory Surgery Centers - Independent Analysis of Annual Sales in US$ Billion for the Years 2020 through 2027

Table 62: China Historic Review for Nerve Repair and Regeneration Devices by End-Use - Hospitals & Clinics and Ambulatory Surgery Centers Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2012 through 2019

Table 63: China 15-Year Perspective for Nerve Repair and Regeneration Devices by End-Use - Percentage Breakdown of Value Sales for Hospitals & Clinics and Ambulatory Surgery Centers for the Years 2012, 2020 & 2027

EUROPE Table 64: Europe Current & Future Analysis for Nerve Repair and Regeneration Devices by Geographic Region - France, Germany, Italy, UK, Spain, Russia and Rest of Europe Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2020 through 2027

Table 65: Europe Historic Review for Nerve Repair and Regeneration Devices by Geographic Region - France, Germany, Italy, UK, Spain, Russia and Rest of Europe Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2012 through 2019

Table 66: Europe 15-Year Perspective for Nerve Repair and Regeneration Devices by Geographic Region - Percentage Breakdown of Value Sales for France, Germany, Italy, UK, Spain, Russia and Rest of Europe Markets for Years 2012, 2020 & 2027

Table 67: Europe Current & Future Analysis for Nerve Repair and Regeneration Devices by Product - Neurostimulation & Neuromodulation Devices and Biomaterials - Independent Analysis of Annual Sales in US$ Billion for the Years 2020 through 2027

Table 68: Europe Historic Review for Nerve Repair and Regeneration Devices by Product - Neurostimulation & Neuromodulation Devices and Biomaterials Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2012 through 2019

Table 69: Europe 15-Year Perspective for Nerve Repair and Regeneration Devices by Product - Percentage Breakdown of Value Sales for Neurostimulation & Neuromodulation Devices and Biomaterials for the Years 2012, 2020 & 2027

Table 70: Europe Current & Future Analysis for Nerve Repair and Regeneration Devices by Application - Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy - Independent Analysis of Annual Sales in US$ Billion for the Years 2020 through 2027

Table 71: Europe Historic Review for Nerve Repair and Regeneration Devices by Application - Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2012 through 2019

Table 72: Europe 15-Year Perspective for Nerve Repair and Regeneration Devices by Application - Percentage Breakdown of Value Sales for Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy for the Years 2012, 2020 & 2027

Table 73: Europe Current & Future Analysis for Nerve Repair and Regeneration Devices by End-Use - Hospitals & Clinics and Ambulatory Surgery Centers - Independent Analysis of Annual Sales in US$ Billion for the Years 2020 through 2027

Table 74: Europe Historic Review for Nerve Repair and Regeneration Devices by End-Use - Hospitals & Clinics and Ambulatory Surgery Centers Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2012 through 2019

Table 75: Europe 15-Year Perspective for Nerve Repair and Regeneration Devices by End-Use - Percentage Breakdown of Value Sales for Hospitals & Clinics and Ambulatory Surgery Centers for the Years 2012, 2020 & 2027

FRANCE Table 76: France Current & Future Analysis for Nerve Repair and Regeneration Devices by Product - Neurostimulation & Neuromodulation Devices and Biomaterials - Independent Analysis of Annual Sales in US$ Billion for the Years 2020 through 2027

Table 77: France Historic Review for Nerve Repair and Regeneration Devices by Product - Neurostimulation & Neuromodulation Devices and Biomaterials Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2012 through 2019

Table 78: France 15-Year Perspective for Nerve Repair and Regeneration Devices by Product - Percentage Breakdown of Value Sales for Neurostimulation & Neuromodulation Devices and Biomaterials for the Years 2012, 2020 & 2027

Table 79: France Current & Future Analysis for Nerve Repair and Regeneration Devices by Application - Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy - Independent Analysis of Annual Sales in US$ Billion for the Years 2020 through 2027

Table 80: France Historic Review for Nerve Repair and Regeneration Devices by Application - Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2012 through 2019

Table 81: France 15-Year Perspective for Nerve Repair and Regeneration Devices by Application - Percentage Breakdown of Value Sales for Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy for the Years 2012, 2020 & 2027

Table 82: France Current & Future Analysis for Nerve Repair and Regeneration Devices by End-Use - Hospitals & Clinics and Ambulatory Surgery Centers - Independent Analysis of Annual Sales in US$ Billion for the Years 2020 through 2027

Table 83: France Historic Review for Nerve Repair and Regeneration Devices by End-Use - Hospitals & Clinics and Ambulatory Surgery Centers Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2012 through 2019

Table 84: France 15-Year Perspective for Nerve Repair and Regeneration Devices by End-Use - Percentage Breakdown of Value Sales for Hospitals & Clinics and Ambulatory Surgery Centers for the Years 2012, 2020 & 2027

GERMANY Table 85: Germany Current & Future Analysis for Nerve Repair and Regeneration Devices by Product - Neurostimulation & Neuromodulation Devices and Biomaterials - Independent Analysis of Annual Sales in US$ Billion for the Years 2020 through 2027

Table 86: Germany Historic Review for Nerve Repair and Regeneration Devices by Product - Neurostimulation & Neuromodulation Devices and Biomaterials Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2012 through 2019

Table 87: Germany 15-Year Perspective for Nerve Repair and Regeneration Devices by Product - Percentage Breakdown of Value Sales for Neurostimulation & Neuromodulation Devices and Biomaterials for the Years 2012, 2020 & 2027

Table 88: Germany Current & Future Analysis for Nerve Repair and Regeneration Devices by Application - Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy - Independent Analysis of Annual Sales in US$ Billion for the Years 2020 through 2027

Table 89: Germany Historic Review for Nerve Repair and Regeneration Devices by Application - Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy Markets - Independent Analysis of Annual Sales in US$ Billion for Years 2012 through 2019

Table 90: Germany 15-Year Perspective for Nerve Repair and Regeneration Devices by Application - Percentage Breakdown of Value Sales for Neurostimulation & Neuromodulation Surgeries, Neurorrhaphy, Nerve Grafting and Stem Cell Therapy for the Years 2012, 2020 & 2027

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The global market for Nerve Repair and Regeneration is projected to reach US$12.7 billion by 2025 - GlobeNewswire

Spinal Cord Stem Cells Comments Off on The global market for Nerve Repair and Regeneration is projected to reach US$12.7 billion by 2025 – GlobeNewswire | September 29th, 2020

Doctors believe they are closer to a treatment for multiple sclerosis after discovering a drug that repairs the coatings around nerves that are damaged by the disease.

A clinical trial of the cancer drug bexarotene showed that it repaired the protective myelin sheaths that MS destroys. The loss of myelin causes a range of neurological problems including balance, vision and muscle disorders, and ultimately, disability.

While bexarotene cannot be used as a treatment, because the side-effects are too serious, doctors behind the trial said the results showed remyelination was possible in humans, suggesting other drugs or drug combinations will halt MS.

Its disappointing that this is not the drug well use, but its exciting that repair is achievable and it gives us great hope for another trial we hope to start this year, said Prof Alasdair Coles, who led the research at the University of Cambridge.

MS arises when the immune system mistakenly attacks the fatty myelin coating that wraps around nerves in the brain and spinal cord. Without the lipid-rich substance, signals travel more slowly along nerves, are disrupted, or fail to get through at all. About 100,000 people in the UK live with the condition.

Funded by the MS Society, bexarotene was assessed in a phase 2a trial that used brain scans to monitor changes to damaged neurons in patients with relapsing MS. This is an early stage of the condition that precedes secondary progressive disease, where neurons die off and cause permanent disability.

The drug had some serious side-effects, from thyroid disease to raised levels of fats in the blood, which can lead to dangerous inflammation of the pancreas. But brain scans revealed that neurons had regrown their myelin sheaths, a finding confirmed by tests that showed signals sent from the retina to the visual cortex at the back of the brain had quickened. That can only be achieved through remyelination, said Coles.

Details of the work were presented on Friday at MSVirtual2020, a joint meeting of the European Committee for Treatment and Research in Multiple Sclerosis and its Americas counterpart.

While bexarotene will not go into phase 3 trials for MS, the finding that the nervous system can be stimulated to resheath damaged neurons has given scientists fresh hopes for another trial they hope to launch later this year. That trial will monitor the effects of the diabetes drug metformin along with clemastine, an antihistamine, a combination that Prof Robin Franklin at the Wellcome-MRC Cambridge Stem Cell Institute showed last year could drive remyelination in animals.

Metformin seems to work by rejuvenating stem cells in the central nervous system, which then go on to become myelin-producing cells called oligodendrocytes. These churn out fresh myelin to replace that destroyed by MS. The researchers hope the drug combination will at least slow the progression of the disease, but there is a chance it will prevent further damage to neurons completely.

The results of this trial give us confidence that medicines that promote myelin regeneration will have a real impact on the treatment of MS, and we look forward to the outcome of future trials with increased optimism, said Franklin.

Dr Emma Gray, at the MS Society, said: Finding treatments to stop MS progression is our number one priority, and to do that we need ways to protect nerves from damage and repair lost myelin. This new research is a major milestone in our plan to stop MS and were incredibly excited about the potential its shown for future studies.

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MS treatment a step closer after drug shown to repair nerve coating - The Guardian

Spinal Cord Stem Cells Comments Off on MS treatment a step closer after drug shown to repair nerve coating – The Guardian | September 26th, 2020

Answers Tatyana Donskikh, head of the clinical diagnostic department, including a day hospital, neurologist of the Federal Center for Medical Sciences of the Federal Medical and Biological Agency of Russia:

Despite all the efforts of modern medicine, no remedy has yet been found that can cure dementia. But it is possible to slow down the development of the disease! And these chances must be used.

Modern treatment is carried out mainly in two directions:

1. Drug therapy.

2. Optimal care that supports mental initiative and a sense of security.

The drugs available to people with dementia today can be divided into three groups:

This group includes a drug used to treat dementia of all severity. Since the binding sites of glutamate are present only in the brain and spinal cord, the agent is well tolerated and has practically no contraindications for administration. This is very important for elderly patients who often have many concomitant diseases.

This group of drugs includes a number of drugs. They prevent the breakdown of acetylcholine already formed in the brain. They are prescribed for mild to moderate severity of the disease. Since acetylcholine is often found outside the brain, acetylcholinesterase inhibitors can cause a number of side effects.

Treatment is carried out for a long time, first as monotherapy, then in combination.

Non-drug approaches to treatment are important, in particular, psychological support for patients and their relatives, neuropsychological training, music therapy, phototherapy, art therapy, aromatherapy and other methods of additional sensory stimulation, therapeutic gymnastics, etc.

Since the prevalence of Alzheimers disease is expected to grow rapidly in the world and the existing therapeutic approaches are rather modest, the search for new forms of action and methods of treatment continues constantly. There are many of these directions. These include, for example, the development of new neuroprotective drugs, neuroreparation technologies using stem cells. Particular hopes were pinned on immunological approaches associated with the use of amyloid vaccines and immunoglobulins in attempts to remove -amyloid from the brain. Unfortunately, clinical trials of amyloid vaccines have shown an unacceptably high risk of developing encephalitis or leukoencephalopathy.

The maximum benefit from any effective remedy is possible only when applied at an early, pre-demented stage of the pathological process. Therefore, it is so important to develop approaches to the earliest possible diagnosis of Alzheimers disease.

There are contraindications, you need to consult a doctor

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What treatments can prolong the life of someone with Alzheimer's? - Pledge Times

Spinal Cord Stem Cells Comments Off on What treatments can prolong the life of someone with Alzheimer’s? – Pledge Times | September 26th, 2020

Setting the tempo for development

Many animals display similarities in their organization (body axis, organ systems, and so on). However, they can display vastly different life spans and thus must accommodate different developmental time scales. Two studies now compare human and mouse development (see the Perspective by Iwata and Vanderhaeghen). Matsuda et al. studied the mechanism by which the human segmentation clock displays an oscillation period of 5 to 6 hours, whereas the mouse period is 2 to 3 hours. They found that biochemical reactions, including protein degradation and delays in gene expression processes, were slower in human cells compared with their mouse counterparts. Rayon et al. looked at the developmental tempo of mouse and human embryonic stem cells as they differentiate to motor neurons in vitro. Neither the sensitivity of cells to signals nor the sequence of gene-regulatory elements could explain the differing pace of differentiation. Instead, a twofold increase in protein stability and cell cycle duration in human cells compared with mouse cells was correlated with the twofold slower rate of human differentiation. These studies show that global biochemical rates play a major role in setting the pace of development.

Science, this issue p. 1450, p. eaba7667; see also p. 1431

What determines the pace of embryonic development? Although the molecular and cellular mechanisms of many developmental processes are evolutionarily conserved, the pace at which these operate varies considerably between species. The tempo of embryonic development controls the rate of individual differentiation processes and determines the overall duration of development. Despite its importance, however, the mechanisms that control developmental tempo remain elusive.

Comparing highly conserved and well-characterized developmental processes in different species permits a search for mechanisms that explain differences in tempo. The specification of neuronal subtype identity in the vertebrate spinal cord is a prominent example, lasting less than a day in zebrafish, 3 to 4 days in mouse, and around 2 weeks in human. The development of the spinal cord involves a well-defined gene regulatory program comprising a series of stereotypic changes in gene expression, regulated by extrinsic signaling as cells differentiate from neural progenitors to postmitotic neurons. The regulatory program and resulting neuronal cell types are highly similar in different vertebrates, despite the difference in tempo between species. We therefore set out to characterize the pace of differentiation of one specific neuronal subtypemotor neuronsin human and mouse and to identify molecular differences that explain differences in pace. To this end, we took advantage of the in vitro recapitulation of in vivo developmental programs using the directed differentiation of human and mouse embryonic stem cells.

We found that all stages of the developmental progression from neural progenitor to motor neuron were proportionally prolonged in human compared with mouse, resulting in human motor neuron differentiation taking about 2.5 times longer than mouse. Differences in tempo were not due to differences in the sensitivity of cells to signals, nor could they be attributed to differences in the sequence of the key genes or their regulatory elements. Instead, the data revealed that changes in protein stability correlated with developmental tempo, such that slower temporal progression in human corresponded to increased protein stability. An in silico model indicated that increased protein stability could account for the slower tempo of development in human compared with mouse.

The results suggest that differences in protein turnover play a role in interspecies differences in the pace of motor neuron differentiation. The identification of a molecular mechanism that can explain differences in the pace of embryonic development between species focuses attention on the role of protein stability in tempo control. This suggests a parsimonious explanation for the substantial variation in the tempo of development between species and indicates how the overall dynamics of developmental processes can be influenced by kinetic properties of gene regulation. What determines species-specific rates of protein turnover remains to be determined, but the availability of in vitro systems that mimic in vivo developmental tempo opens up the possibility of exploring this issue.

Different animal species develop at different tempos, and equivalent developmental stages can be matched between mouse and human at different developmental time points. Neural progenitors in the spinal cord progress through the same succession of gene expression to generate motor neurons in mouse and human, and this serves as a model to study tempo differences. The in vitro directed differentiation of mouse embryonic stem cells to motor neurons advances at greater than twice the speed of human embryonic stem cell differentiation. The equivalent progression of development at different rates is shown for the transcription factors PAX6 (green), OLIG2 (red), and NKX2.2 (blue). E, embryonic day; W, embryonic week; CS, Carnegie stage. Scale bars are 50 m.

Although many molecular mechanisms controlling developmental processes are evolutionarily conserved, the speed at which the embryo develops can vary substantially between species. For example, the same genetic program, comprising sequential changes in transcriptional states, governs the differentiation of motor neurons in mouse and human, but the tempo at which it operates differs between species. Using in vitro directed differentiation of embryonic stem cells to motor neurons, we show that the program runs more than twice as fast in mouse as in human. This is not due to differences in signaling, nor the genomic sequence of genes or their regulatory elements. Instead, there is an approximately two-fold increase in protein stability and cell cycle duration in human cells compared with mouse cells. This can account for the slower pace of human development and suggests that differences in protein turnover play a role in interspecies differences in developmental tempo.

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Species-specific pace of development is associated with differences in protein stability - Science Magazine

Spinal Cord Stem Cells Comments Off on Species-specific pace of development is associated with differences in protein stability – Science Magazine | September 18th, 2020

Sept. 9, 2020 12:00 UTC

ALAMEDA, Calif. & CARLSBAD, Calif.--(BUSINESS WIRE)-- AgeX Therapeutics, Inc.(AgeX: NYSE American: AGE), a company focused on developing and commercializing innovative therapeutics for human aging, and Lineage Cell Therapeutics, Inc.. (Lineage: NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, and ES Cell International Pte Ltd. (ESI), a subsidiary of Lineage, today announced the broadening of their collaborative relationship with regard to ESI stem cell lines. ESI cell lines are current Good Manufacturing Practice (cGMP)-compatible, registered with the National Institutes of Health (NIH), and widely studied as a potential source for the industrial-scale manufacture of any cell type in the human body. Neither party made or received any cash payments in connection with this arrangement.

Both Lineage and AgeX are pioneering important aspects of regenerative medicine. Working together, we have amended our agreement regarding ESI cell lines derived under cGMP to be optimal for the business needs of each company, stated Brian M. Culley, Lineages CEO. In particular, Lineage has acquired exclusivity for the use of ESI cell lines in spinal cord injury and certain oncology indications. On the other hand, AgeX has gained greater flexibility and independence to support its efforts toward licensing certain technologies and cell lines to third parties. With this step complete, we next intend to explore additional opportunities to collaborate with AgeX on promising tissue regenerating projects.

The ESI cell lines are recognized for being the first clinical-grade human pluripotent stem cell lines created under cGMP as described in the publication Cell Stem Cell (2007;1:490-4). It may become possible to generate potentially limitless quantities of all the cell types of the human body from these master cell banks with a wide array of potential therapeutic applications. These cell lines are listed on the NIH Stem Cell Registry and are among the best characterized and documented stem cell lines available globally. Importantly, ESI cells are among only a few pluripotent stem cell lines from which a derived cell therapy product candidate has been granted FDA investigational new drug (IND) clearance to commence human studies.

Key to the creation of shareholder value is the placement of these important assets in the hands of collaborators to advance the development of a vast number of regenerative therapies, said Michael West, Ph.D., AgeXs CEO. Our collaborative relationship with Lineage led to this streamlined process that may facilitate the commercialization of these applications to the benefit of shareholders of each company. Since the beginning of the year, AgeX has entered into new research and commercial arrangements utilizing an array of its technology platforms, such as UniverCyteTM for the engineering of universally transplantable cells, PureStem for the manufacture and derivation of cells, and an ESI cell line as source material for deriving cellular therapeutics.

About AgeX Therapeutics, Inc

AgeX Therapeutics, Inc. (NYSE American: AGE) is focused on developing and commercializing innovative therapeutics for human aging. Its PureStem and UniverCyte manufacturing and immunotolerance technologies are designed to work together to generate highly defined, universal, allogeneic, off-the-shelf pluripotent stem cell-derived young cells of any type for application in a variety of diseases with a high unmet medical need. AgeX has two preclinical cell therapy programs: AGEX-VASC1 (vascular progenitor cells) for tissue ischemia and AGEX-BAT1 (brown fat cells) for Type II diabetes. AgeXs revolutionary longevity platform induced Tissue Regeneration (iTR) aims to unlock cellular immortality and regenerative capacity to reverse age-related changes within tissues. AGEX-iTR1547 is an iTR-based formulation in preclinical development. HyStem is AgeXs delivery technology to stably engraft PureStem cell therapies in the body. AgeXs core product pipeline is intended to extend human healthspan. AgeX is seeking opportunities to establish licensing and collaboration arrangements around its broad IP estate and proprietary technology platforms and therapy product candidates. For more information, please visit http://www.agexinc.com or connect with the company on Twitter, LinkedIn, Facebook, and YouTube.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineages programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineages clinical programs are in markets with billion dollar opportunities and include three allogeneic (off-the-shelf) product candidates: (i) OpRegen, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer and in preclinical development for additional cancers and as a vaccine against infectious diseases, including SARS-CoV-2, the virus which causes COVID-19. For more information, please visit http://www.lineagecell.com or follow the Company on Twitter @LineageCell.

About ESI

ES Cell International Pte Ltd (ESI). Established in 2000, ESI, a wholly owned subsidiary of Lineage Cell Therapeutics, Inc., developed ESI hESC lines in compliance with the principles of current Good Manufacturing Practices and has made them available to various biopharmaceutical companies, universities and other research institutions, including AgeX. These ESI cell lines are extensively characterized and most of the lines have documented and publicly available genomic sequences.

Forward-Looking Statements for AgeX

Certain statements contained in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not historical fact including, but not limited to statements that contain words such as will, believes, plans, anticipates, expects, estimates should also be considered forward-looking statements. Forward-looking statements involve risks and uncertainties. Without limitation, such risks include those associated with the use of human pluripotent stem cell lines in the research, development, and use of therapies for the treatment of human diseases, disorders, and injuries, and risks associated with commercializing the pluripotent stem cell lines. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of AgeX Therapeutics, Inc. and its respective subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the Risk Factors section of its most recent Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commissions (copies of which may be obtained at http://www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. Undue reliance should not be placed on forward-looking statements, which speak only as of the date on which they were made. AgeX specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.

Forward-Looking Statements for Lineage

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as believe, may, will, estimate, continue, anticipate, design, intend, expect, could, plan, potential, predict, seek, should, would, contemplate, project, target, tend to, or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to the potential commercialization of ESI cell lines. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineages actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineages business and other risks in Lineages filings with the Securities and Exchange Commission (the SEC). Lineages forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading Risk Factors in Lineages periodic reports with the SEC, including Lineages Annual Report on Form 10-K filed with the SEC on March 12, 2020 and its other reports, which are available from the SECs website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200909005398/en/

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AgeX Therapeutics and Lineage Cell Therapeutics Announce Expansion of Agreement Related to ESI Clinical-grade Pluripotent Stem Cell Lines for...

Spinal Cord Stem Cells Comments Off on AgeX Therapeutics and Lineage Cell Therapeutics Announce Expansion of Agreement Related to ESI Clinical-grade Pluripotent Stem Cell Lines for… | September 9th, 2020

AgeX Therapeutics, Inc. (AgeX: NYSE American: AGE), a company focused on developing and commercializing innovative therapeutics for human aging, and Lineage Cell Therapeutics, Inc. (Lineage: NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, and ES Cell International Pte Ltd. (ESI), a subsidiary of Lineage, today announced the broadening of their collaborative relationship with regard to ESI stem cell lines. ESI cell lines are current Good Manufacturing Practice (cGMP)-compatible, registered with the National Institutes of Health (NIH), and widely studied as a potential source for the industrial-scale manufacture of any cell type in the human body. Neither party made or received any cash payments in connection with this arrangement.

Both Lineage and AgeX are pioneering important aspects of regenerative medicine. Working together, we have amended our agreement regarding ESI cell lines derived under cGMP to be optimal for the business needs of each company, stated Brian M. Culley, Lineages CEO. In particular, Lineage has acquired exclusivity for the use of ESI cell lines in spinal cord injury and certain oncology indications. On the other hand, AgeX has gained greater flexibility and independence to support its efforts toward licensing certain technologies and cell lines to third parties. With this step complete, we next intend to explore additional opportunities to collaborate with AgeX on promising tissue regenerating projects.

The ESI cell lines are recognized for being the first clinical-grade human pluripotent stem cell lines created under cGMP as described in the publication Cell Stem Cell (2007;1:490-4). It may become possible to generate potentially limitless quantities of all the cell types of the human body from these master cell banks with a wide array of potential therapeutic applications. These cell lines are listed on the NIH Stem Cell Registry and are among the best characterized and documented stem cell lines available globally. Importantly, ESI cells are among only a few pluripotent stem cell lines from which a derived cell therapy product candidate has been granted FDA investigational new drug (IND) clearance to commence human studies.

Key to the creation of shareholder value is the placement of these important assets in the hands of collaborators to advance the development of a vast number of regenerative therapies, said Michael West, Ph.D., AgeXs CEO. Our collaborative relationship with Lineage led to this streamlined process that may facilitate the commercialization of these applications to the benefit of shareholders of each company. Since the beginning of the year, AgeX has entered into new research and commercial arrangements utilizing an array of its technology platforms, such as UniverCyteTM for the engineering of universally transplantable cells, PureStem for the manufacture and derivation of cells, and an ESI cell line as source material for deriving cellular therapeutics.

About AgeX Therapeutics, Inc

AgeX Therapeutics, Inc. (NYSE American: AGE) is focused on developing and commercializing innovative therapeutics for human aging. Its PureStem and UniverCyte manufacturing and immunotolerance technologies are designed to work together to generate highly defined, universal, allogeneic, off-the-shelf pluripotent stem cell-derived young cells of any type for application in a variety of diseases with a high unmet medical need. AgeX has two preclinical cell therapy programs: AGEX-VASC1 (vascular progenitor cells) for tissue ischemia and AGEX-BAT1 (brown fat cells) for Type II diabetes. AgeXs revolutionary longevity platform induced Tissue Regeneration (iTR) aims to unlock cellular immortality and regenerative capacity to reverse age-related changes within tissues. AGEX-iTR1547 is an iTR-based formulation in preclinical development. HyStem is AgeXs delivery technology to stably engraft PureStem cell therapies in the body. AgeXs core product pipeline is intended to extend human healthspan. AgeX is seeking opportunities to establish licensing and collaboration arrangements around its broad IP estate and proprietary technology platforms and therapy product candidates. For more information, please visit http://www.agexinc.com or connect with the company on Twitter, LinkedIn, Facebook, and YouTube.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineages programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineages clinical programs are in markets with billion dollar opportunities and include three allogeneic (off-the-shelf) product candidates: (i) OpRegen, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer and in preclinical development for additional cancers and as a vaccine against infectious diseases, including SARS-CoV-2, the virus which causes COVID-19. For more information, please visit http://www.lineagecell.com or follow the Company on Twitter @LineageCell.

About ESI

ES Cell International Pte Ltd (ESI). Established in 2000, ESI, a wholly owned subsidiary of Lineage Cell Therapeutics, Inc., developed ESI hESC lines in compliance with the principles of current Good Manufacturing Practices and has made them available to various biopharmaceutical companies, universities and other research institutions, including AgeX. These ESI cell lines are extensively characterized and most of the lines have documented and publicly available genomic sequences.

Forward-Looking Statements for AgeX

Certain statements contained in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not historical fact including, but not limited to statements that contain words such as will, believes, plans, anticipates, expects, estimates should also be considered forward-looking statements. Forward-looking statements involve risks and uncertainties. Without limitation, such risks include those associated with the use of human pluripotent stem cell lines in the research, development, and use of therapies for the treatment of human diseases, disorders, and injuries, and risks associated with commercializing the pluripotent stem cell lines. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of AgeX Therapeutics, Inc. and its respective subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the Risk Factors section of its most recent Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commissions (copies of which may be obtained at http://www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. Undue reliance should not be placed on forward-looking statements, which speak only as of the date on which they were made. AgeX specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.

Forward-Looking Statements for Lineage

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as believe, may, will, estimate, continue, anticipate, design, intend, expect, could, plan, potential, predict, seek, should, would, contemplate, project, target, tend to, or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to the potential commercialization of ESI cell lines. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineages actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineages business and other risks in Lineages filings with the Securities and Exchange Commission (the SEC). Lineages forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading Risk Factors in Lineages periodic reports with the SEC, including Lineages Annual Report on Form 10-K filed with the SEC on March 12, 2020 and its other reports, which are available from the SECs website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200909005398/en/

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Lineage Cell Therapeutics : AgeX Therapeutics and Lineage Cell Therapeutics Announce Expansion of Agreement Related to ESI Clinical-grade Pluripotent...

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DUBLIN, Sept. 2, 2020 /PRNewswire/ -- The "Global Cord Blood Banking Industry Report 2020" report has been added to ResearchAndMarkets.com's offering.

This report presents the number of cord blood units stored in inventory by the largest cord blood banks worldwide and the number of cord blood units (CBUs) released by registries across the world for hematopoietic stem cell (HSC) transplantation. Although cord blood is now used to treat more than 80 different diseases, this number could substantially expand if applications related to regenerative medicine start receiving approvals in major healthcare markets worldwide.

From the early 1900s through the mid-2000s, the global cord blood banking industry expanded rapidly, with companies opening for business in all major markets worldwide. From 2005 to 2010, the market reached saturation and stabilized.

Then, from 2010 to 2020, the market began to aggressively consolidate. This has created both serious threats and unique opportunities within the industry.

Serious threats to the industry include low rates of utilization for stored cord blood, expensive cord blood transplantation procedures, difficulty educating obstetricians about cellular therapies, and an increasing trend toward industry consolidation. There are also emerging opportunities for the industry, such as accelerated regulatory pathways for cell therapies in leading healthcare markets worldwide and expanding applications for cell-based therapies. In particular, MSCs from cord tissue (and other sources) are showing intriguing promise in the treatment and management of COVID-19.

Cord Blood Industry Trends

Within recent years, new themes have been impacting the industry, including the pairing of stem cell storage services with genetic and genomic testing services, as well as reproductive health services. Cord blood banks are diversifying into new types of stem cell storage, including umbilical cord tissue storage, placental blood and tissue, amniotic fluid and tissue, and dental pulp. Cord blood banks are also investigating means of becoming integrated therapeutic companies. With hundreds of companies offering cord blood banking services worldwide, maturation of the market means that each company is fighting harder for market share.

Growing numbers of investors are also entering the marketplace, with M&A activity accelerating in the U.S. and abroad. Holding companies are emerging as a global theme, allowing for increased operational efficiency and economy of scale. Cryoholdco has established itself as the market leader within Latin America. Created in 2015, Cryoholdco is a holding company that will control nearly 270,000 stem cell units by the end of 2020. It now owns a half dozen cord blood banks, as well as a dental stem cell storage company.

Globally, networks of cord blood banks have become commonplace, with Sanpower Group establishing its dominance in Asia. Although Sanpower has been quiet about its operations, it holds 4 licenses out of only 7 issued provincial-level cord blood bank licenses in China. It has reserved over 900,000 cord blood samples in China, and its reserves amount to over 1.2 million units when Cordlife' reserves within Southeast Asian countries are included. This positions Sanpower Group and it's subsidiary Nanjing Cenbest as the world's largest cord blood banking operator not only in China and Southeast Asia but in the world.

The number of cord blood banks in Europe has dropped by more than one-third over the past ten years, from approximately 150 to under 100. The industry leaders in this market segment include FamiCord Group, who has executed a dozen M&A transactions, and Vita34, who has executed approximately a half dozen. Stemlab, the largest cord blood bank in Portugal, also executed three acquisition deals prior to being acquired by FamiCord. FamiCord is now the leading stem cell bank in Europe and one of the largest worldwide.

Cord Blood Expansion Technologies

Because cord blood utilization is largely limited to use in pediatric patients, growing investment is flowing into ex vivo cord blood expansion technologies. If successful, this technology could greatly expand the market potential for cord blood, encouraging its use within new markets, such as regenerative medicine, aging, and augmented immunity.

Key strategies being explored for this purpose include:

Currently, Gamida Cell, Nohla Therapeutics, Excellthera, and Magenta Therapeutics have ex vivo cord blood expansion products proceeding through clinical trials. Growing numbers of investors have also entered the cord blood banking marketplace, led by groups such as GI Partners, ABS Capital Partners & HLM Management, KKR & Company, Bay City Capital, GTCR, LLC, and Excalibur.

Cord Blood Banking by Region

Within the United States, most of the market share is controlled by three major players: Cord Blood Registry (CBR), Cryo-Cell, and ViaCord. CBR has been traded twice, once in 2015 to AMAG Pharmaceuticals for $700 million and again in 2018 to GI Partners for $530 million. CBR also bought Natera's Evercord Cord Blood Banking business in September 2019. In total, CBR controls over 900,000 cord blood and tissue samples, making it one of the largest cord blood banks worldwide.

In China, the government controls the industry by authorizing only one cord blood bank to operate within each province, and official government support, authorization, and permits are required. Importantly, the Chinese government announced in late 2019 that it will be issuing new licenses for the first time, expanding from the current 7 licensed regions for cord blood banking to up to 19 regions, including Beijing.

In Italy and France, it is illegal to privately store one's cord blood, which has fully eliminated the potential for a private market to exist within the region. In Ecuador, the government created the first public cord blood bank and instituted laws such that private cord blood banks cannot approach women about private cord blood banking options during the first six months of pregnancy. This created a crisis for private banks, forcing most out of business.

Recently, India's Central Drugs Standard Control Organization (CDSCO) restricted commercial banking of stem cells from most biological materials, including cord tissue, placenta, and dental pulp stem cells - leaving only umbilical cord blood banking as permitted and licensed within the country.

While market factors vary by geography, it is crucial to have a global understanding of the industry, because research advances, clinical trial findings, and technology advances do not know international boundaries. The cord blood market is global in nature and understanding dynamics within your region is not sufficient for making strategic, informed, and profitable decisions.

Overall, the report provides the reader with the following details and answers the following questions:

1. Number of cord blood units cryopreserved in public and private cord blood banks globally2. Number of hematopoietic stem cell transplants (HSCTs) globally using cord blood cells3. Utilization of cord blood cells in clinical trials for developing regenerative medicines4. The decline of the utilization of cord blood cells in HSC transplantations since 20055. Emerging technologies to influence the financial sustainability of public cord blood banks6. The future scope for companion products from cord blood7. The changing landscape of cord blood cell banking market8. Extension of services by cord blood banks9. Types of cord blood banks10. The economic model of public cord blood banks11. Cost analysis for public cord blood banks12. The economic model of private cord blood banks13. Cost analysis for private cord blood banks14. Profit margins for private cord blood banks15. Pricing for processing and storage in private banks16. Rate per cord blood unit in the U.S. and Europe17. Indications for the use of cord blood-derived HSCs for transplantations18. Diseases targeted by cord blood-derived MSCs in regenerative medicine19. Cord blood processing technologies20. Number of clinical trials, number of published scientific papers and NIH funding for cord blood research21. Transplantation data from different cord blood registries

Key questions answered in this report are:

1. What are the strategies being considered for improving the financial stability of public cord blood banks?2. What are the companion products proposed to be developed from cord blood?3. How much is being spent on processing and storing a unit of cord blood?4. How much does a unit of cryopreserved cord blood unit fetch on release?5. Why do most public cord blood banks incur a loss?6. What is the net profit margin for a private cord blood bank?7. What are the prices for processing and storage of cord blood in private cord blood banks?8. What are the rates per cord blood units in the U.S. and Europe?9. What are the revenues from cord blood sales for major cord blood banks?10. Which are the different accreditation systems for cord blood banks?11. What are the comparative merits of the various cord blood processing technologies?12. What is to be done to increase the rate of utilization of cord blood cells in transplantations?13. Which TNC counts are preferred for transplantation?14. What is the number of registered clinical trials using cord blood and cord tissue?15. How many clinical trials are involved in studying the expansion of cord blood cells in the laboratory?16. How many matching and mismatching transplantations using cord blood units are performed on an annual basis?17. What is the share of cord blood cells used for transplantation from 2000 to 2020?18. What is the likelihood of finding a matching allogeneic cord blood unit by ethnicity?19. Which are the top ten countries for donating cord blood?20. What are the diseases targeted by cord blood-derived MSCs within clinical trials?

Key Topics Covered

1. REPORT OVERVIEW1.1 Statement of the Report1.2 Executive Summary1.3 Introduction1.3.1 Cord Blood: An Alternative Source for HPSCs1.3.2 Utilization of Cord Blood Cells in Clinical Trials1.3.3 The Struggle of Cord Blood Banks1.3.4 Emerging Technologies to Influence Financial Sustainability of Banks1.3.4.1 Other Opportunities to Improve Financial Stability1.3.4.2 Scope for Companion Products1.3.5 Changing Landscape of Cord Blood Cell Banking Market1.3.6 Extension of Services by Cord Blood Banks

2. CORD BLOOD & CORD BLOOD BANKING: AN OVERVIEW2.1 Cord Blood Banking (Stem Cell Banking)2.1.1 Public Cord Blood Banks2.1.1.1 Economic Model of Public Cord Blood Banks2.1.1.2 Cost Analysis for Public Banks2.1.1.3 Relationship between Costs and Release Rates2.1.2 Private Cord Blood Banks2.1.2.1 Cost Analysis for Private Cord Blood Banks2.1.2.2 Economic Model of Private Banks2.1.3 Hybrid Cord Blood Banks2.2 Globally Known Cord Blood Banks2.2.1 Comparing Cord Blood Banks2.2.2 Cord Blood Banks in the U.S.2.2.3 Proportion of Public, Private and Hybrid Banks2.3 Percent Share of Parents of Newborns Storing Cord Blood by Country/Region2.4 Pricing for Processing and Storage in Commercial Banks2.4.1 Rate per Cord Blood Unit in the U.S. and Europe2.5 Cord Blood Revenues for Major Cord Blood Banks

3. CORD BLOOD BANK ACCREDITATIONS3.1 American Association of Blood Banks (AABB)3.2 Foundation for the Accreditation of Cellular Therapy (FACT)3.3 FDA Registration3.4 FDA Biologics License Application (BLA) License3.5 Investigational New Drug (IND) for Cord Blood3.6 Human Tissue Authority (HTA)3.7 Therapeutic Goods Act (TGA) in Australia3.8 International NetCord Foundation3.9 AABB Accredited Cord Blood Facilities3.10 FACT Accreditation for Cord Blood Banks

4. APPLICATIONS OF CORD BLOOD CELLS4.1 Hematopoietic Stem Cell Transplantations with Cord Blood Cells4.2 Cord Cells in Regenerative Medicine

5. CORD BLOOD PROCESSING TECHNOLOGIES5.1 The Process of Separation5.1.1 PrepaCyte-CB5.1.2 Advantages of PrepaCyte-CB5.1.3 Treatment Outcomes with PrepaCyte-CB5.1.4 Hetastarch (HES)5.1.5 AutoXpress (AXP)5.1.6 SEPAX5.1.7 Plasma Depletion Method (MaxCell Process)5.1.8 Density Gradient Method5.2 Comparative Merits of Different Processing Methods5.2.1 Early Stage HSC Recovery by Technologies5.2.2 Mid Stage HSC (CD34+/CD133+) Recovery from Cord Blood5.2.3 Late Stage Recovery of HSCs from Cord Blood5.3 HSC (CD45+) Recovery5.4 Days to Neutrophil Engraftment by Technology5.5 Anticoagulants used in Cord Blood Processing5.5.1 Type of Anticoagulant and Cell Recovery Volume5.5.2 Percent Cell Recovery by Sample Size5.5.3 TNC Viability by Time Taken for Transport and Type of Anticoagulant5.6 Cryopreservation of Cord Blood Cells5.7 Bioprocessing of Umbilical Cord Tissue (UCT)5.8 A Proposal to Improve the Utilization Rate of Banked Cord Blood

6. CORD BLOOD CLINICAL TRIALS, SCIENTIFIC PUBLICATIONS & NIH FUNDING6.1 Cord Blood Cells for Research6.2 Cord Blood Cells for Clinical Trials6.2.1 Number of Clinical Trials involving Cord Blood Cells6.2.2 Number of Clinical Trials using Cord Blood Cells by Geography6.2.3 Number of Clinical Trials by Study Type6.2.4 Number of Clinical Trials by Study Phase6.2.5 Number of Clinical Trials by Funder Type6.2.6 Clinical Trials Addressing Indications in Children6.2.7 Select Three Clinical Trials Involving Children6.2.7.1 Sensorineural Hearing Loss (NCT02038972)6.2.7.2 Autism Spectrum (NCT02847182)6.2.7.3 Cerebral Palsy (NCT01147653)6.2.8 Clinical Trials for Neurological Diseases using Cord Blood and Cord Tissue6.2.9 UCB for Diabetes6.2.10 UCB in Cardiovascular Clinical Trials6.2.11 Cord Blood Cells for Auto-Immune Diseases in Clinical Trials6.2.12 Cord Tissue Cells for Orthopedic Disorders in Clinical Trials6.2.13 Cord Blood Cells for Other Indications in Clinical Trials6.3 Major Diseases Addressed by Cord Blood Cells in Clinical Trials6.4 Clinical Trials using Cord Tissue-Derived MSCs6.5 Ongoing Clinical Trials using Cord Tissue6.5.1 Cord Tissue-Based Clinical Trials by Geography6.5.2 Cord Tissue-Based Clinical Trials by Phase6.5.3 Cord Tissue-Based Clinical Trials by Sponsor Types6.5.4 Companies Sponsoring in Trials using Cord Tissue-Derived MSCs6.6 Wharton's Jelly-Derived MSCs in Clinical Trials6.6.1 Wharton's Jelly-Based Clinical Trials by Phase6.6.2 Companies Sponsoring Wharton's Jelly-Based Clinical Trials6.7 Clinical Trials Involving Cord Blood Expansion Studies6.7.1 Safe and Feasible Expansion Protocols6.7.2 List of Clinical Trials involved in the Expansion of Cord Blood HSCs6.7.3 Expansion Technologies6.8 Scientific Publications on Cord Blood6.9 Scientific Publications on Cord Tissue6.10 Scientific Publications on Wharton's Jelly-Derived MSCs6.11 Published Scientific Papers on Cord Blood Cell Expansion6.12 NIH Funding for Cord Blood Research

7. PARENT'S AWARENESS AND ATTITUDE TOWARDS CORD BLOOD BANKING7.1 Undecided Expectant Parents7.2 The Familiar Cord Blood Banks Known by the Expectant Parents7.3 Factors Influencing the Choice of a Cord Blood Bank

8. CORD BLOOD: AS A TRANSPLANTATION MEDICINE8.1 Comparisons of Cord Blood to other Allograft Sources8.1.1 Major Indications for HCTs in the U.S.8.1.2 Trend in Allogeneic HCT in the U.S. by Recipient Age8.1.3 Trends in Autologous HCT in the U.S. by Recipient Age8.2 HCTs by Cell Source in Adult Patients8.2.1 Transplants by Cell Source in Pediatric Patients8.3 Allogeneic HCTs by Cell Source8.3.1 Unrelated Donor Allogeneic HCTs in Patients &lessThan;18 Years8.4 Likelihood of Finding an Unrelated Cord Blood Unit by Ethnicity8.4.1 Likelihood of Finding an Unrelated Cord Blood Unit for Patients &lessThan;20 Years8.5 Odds of using a Baby's Cord Blood8.6 Cord Blood Utilization Trends8.7 Number of Cord Blood Donors Worldwide8.7.1 Number of CBUs Stored Worldwide8.7.2 Cord Blood Donors by Geography8.7.2.1 Cord Blood Units Stored in Different Geographies8.7.2.2 Number of Donors by HLA Typing8.7.3 Searches Made by Transplant Patients for Donors/CBUs8.7.4 Types of CBU Shipments (Single/Double/Multi)8.7.5 TNC Count of CBUs Shipped for Children and Adult Patients8.7.6 Shipment of Multiple CBUs8.7.7 Percent Supply of CBUs for National and International Patients8.7.8 Decreasing Number of CBU Utilization8.8 Top Ten Countries in Cord Blood Donation8.8.1 HLA Typed CBUs by Continent8.8.2 Percentage TNC of Banked CBUs8.8.3 Total Number of CBUs, HLA-Typed Units by Country8.9 Cord Blood Export/Import by the E.U. Member States8.9.1 Number of Donors and CBUs in Europe8.9.2 Number of Exports/Imports of CBUs in E.U.8.10 Global Exchange of Cord Blood Units

9. CORD BLOOD CELLS AS THERAPEUTIC CELL PRODUCTS IN CELL THERAPY9.1 MSCs from Cord Blood and Cord Tissue9.1.1 Potential Neurological Applications of Cord Blood-Derived Cells9.1.2 Cord Tissue-Derived MSCs for Therapeutic use9.1.2.1 Indications Targeted by UCT-MSCs in Clinical Trials9.2 Current Consumption of Cord Blood Units by Clinical Trials9.3 Select Cord Blood Stem Cell Treatments in Clinical Trials9.3.1 Acquired Hearing Loss (NCT02038972)9.3.2 Autism (NCT02847182)9.3.3 Cerebral Palsy (NCT03087110)9.3.4 Hypoplastic Left Heart Syndrome (NCT01856049)9.3.5 Type 1 Diabetes (NCT00989547)9.3.6 Psoriasis (NCT03765957)9.3.7 Parkinson's Disease (NCT03550183)9.3.8 Signs of Aging (NCT04174898)9.3.9 Stroke (NCT02433509)9.3.10 Traumatic Brain Injury (NCT01451528)

10. MARKET ANALYSIS10.1 Public vs. Private Cord Blood Banking Market10.2 Cord Blood Banking Market by Indication

11. PROFILES OF SELECT CORD BLOOD BANKS11.1 AllCells11.1.1 Whole Blood11.1.2 Leukopak11.1.3 Mobilized Leukopak11.1.4 Bone Marrow11.1.5 Cord Blood11.2 AlphaCord LLC11.2.1 NextGen Collection System11.3 Americord Registry, Inc.11.3.1 Cord Blood 2.011.3.2 Cord Tissue11.3.3 Placental Tissue 2.011.4 Be The Match11.4.1 Hub of Transplant Network11.4.2 Partners of Be The Match11.4.3 Allogeneic Cell Sources in Be The Match Registry11.4.4 Likelihood of a Matched Donor on Be The Match by Ethnic Background11.5 Biocell Center Corporation11.5.1 Chorionic villi after Delivery11.5.2 Amniotic Fluid and Chorionic Villi during Pregnancy11.6 BioEden Group, Inc.11.6.1 Differences between Tooth Cells and Umbilical Cord Cells11.7 Biovault Family11.7.1 Personalized Cord Blood Processing11.8 Cell Care11.9 Cells4Life Group, LLP11.9.1 Cells4Life's pricing11.9.2 TotiCyte Technology11.9.3 Cord Blood Releases11.10 Cell-Save11.11 Center for International Blood and Marrow Transplant Research (CIBMTR)11.11.1 Global Collaboration11.11.2 Scientific Working Committees11.11.3 Medicare Clinical Trials and Studies11.11.4 Cellular Therapy11.12 Crio-Cell International, Inc.11.12.1 Advanced Collection Kit11.12.2 Prepacyte-CB11.12.3 Crio-Cell International's Pricing11.12.4 Revenue for Crio-Cell International11.13 Cord Blood Center Group11.13.1 Cord Blood Units Released11.14 Cordlife Group, Ltd.11.14.1 Cordlife's Cord Blood Release Track Record11.15 Core23 Biobank11.16 Cord Blood Registry (CBR)11.17 CordVida11.18 Crioestaminal11.18.1 Cord Blood Transplantation in Portugal11.19 Cryo-Cell International, Inc.11.19.1 Processing Method11.19.2 Financial Results of the Company11.20 CryoHoldco11.21 Cryoviva Biotech Pvt. Ltd11.22 European Society for Blood and Bone Marrow Transplantation (EBMT)11.22.1 EBMT Transplant Activity11.23 FamiCord Group11.24 GeneCell International11.25 Global Cord Blood Corporation11.25.1 The Company's Business11.26 HealthBaby Hong Kong11.26.1 BioArchive System Service Plan11.26.2 MVE Liquid Nitrogen System11.27 HEMAFUND11.28 Insception Lifebank11.29 LifebankUSA11.29.1 Placental Banking11.30 LifeCell International Pvt. Ltd.11.31 MiracleCord, Inc.11.32 Maze Cord Blood Laboratories11.33 New England Cord Blood Bank, Inc.11.34 New York Cord Blood Center (NYBC)11.34.1 Products11.34.2 Laboratory Services11.35 PacifiCord11.35.1 FDA-Approved Sterile Collection Bags11.35.2 AXP Processing System11.35.3 BioArchive System11.36 ReeLabs Pvt. Ltd.11.37 Smart Cells International, Ltd.11.38 Stem Cell Cryobank11.39 StemCyte, Inc.11.39.1 StemCyte Sponsored Clinical Trials11.39.1.1 Spinal Cord Injury Phase II11.39.1.2 Other Trials11.40 Transcell Biolife11.40.1 ScellCare11.40.2 ToothScell11.41 ViaCord11.42 Vita 34 AG11.43 World Marrow Donor Association (WMDA)11.43.1 Search & Match Service11.44 Worldwide Network for Blood & Marrow Transplantation (WBMT)

For more information about this report visit https://www.researchandmarkets.com/r/7bm9lx

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Global Cord Blood Banking Market 2020 with Analysis of 44 Industry Players - PRNewswire

Spinal Cord Stem Cells Comments Off on Global Cord Blood Banking Market 2020 with Analysis of 44 Industry Players – PRNewswire | September 3rd, 2020

HACKENSACK, N.J., Sept. 1, 2020 /PRNewswire/ --Royal Biologics, an ortho-biologics company specializing in the research and advancement of autologous and live cellular solutions, today announced the completed acquisition of FIBRINET, from Vertical Spine LLC. The acquisition comes as part of Royal Biologics' strategic initiative to add novel technologies to its growing portfolio of autologous and live cellular solutions to support orthopedic and spinal fusion.

The FIBRINET system utilizes a patient's own autologous blood to create a platelet-rich fibrin matrix/membrane (PRFM). During this process, a patient's autologous platelets are harvested first through centrifugation and then combined with a proprietary solution to solidify into a fibrin clot/membrane. PRFM can be used to help augment spinal fusions and provide surgeons a new and novel biologic option. FIBRINET is the first commercialized system that utilizes a non-thrombin solution to create a reproducible platelet-rich fibrin matrix. The use of its proprietary solution to solidify a fibrin membrane provides the unique advantage of creating a biologic reservoir of growth factors and stem cells that can be held and used at the point of care for spinal fusion.

"We are extremely excited to add FIBRINET to our growing portfolio of autologous and live cellular therapies," says Salvatore Leo, Royal Biologics Chief Executive Officer. "FIBRINET'S technology now allows surgeons to harvest a patient's autologous cells and create a unique platelet-rich fibrin membrane-scaffold to be used at the point of care in most spinal fusion procedures. When added to our current product portfolio of autologous and live cellular therapies, we feel that providing each patient an opportunity to harvest their own unique cells for treatment is a superior option in many surgical settings."

FIBRINET has shown promising results and has been adopted into major orthopedic institutions in the United States. Hospitals such as Hospital for Special Surgery, Mount Sinai, NY Presbyterian and Connecticut's Orthopaedic Institute have all adopted FIBRINET into their spine services portfolio of approved products for use.

In a recent European Spine Journalstudy, at a one-year follow-up, FIBRINET demonstrated over a 92.4% radiographic fusion, and there was a significant improvement recorded in VAS scores for both back and leg pain. Compared to baseline figures, the number of patients using opioid analgesics at 12 months decreased by 38%. While the majority (31/50) of patients that participated in the study were retired, 68% of the employed patients were able to return to work.1

"FIBRINET presents itself as a low-cost option to obtain premium, high-quality viable cells from the patient for each fusion procedure," comments Dr. James Yue, Co-Chief and Orthopedic Spine Surgeon at Midstate Medical Center. "During this pandemic, a time when patients are having difficulty receiving operations in major hospital systems, the transition of procedures to ambulatory surgery centers has become even more desired and essential. FIBRINET's low-cost bundle provides surgeons the ability to offer a live viable cell product, point of care in a streamlined and safe environment for spinal fusion."

As part of a national re-launch plan for FIBRINET, Royal Biologics has just launched a new 3D animated moviethat demonstrates the unique features and benefits of FIBRINET's technology. "We wanted to show surgeons, distributors and our peers a new and creative take on Autologous & Live Cellular therapy," comments Leo. "With the recent pandemic and industry environment, we felt it was necessary to help create a unique viewing experience of the FIBRINET system."

FIBRINET comes after two other recent product launches from Royal Biologics in Q1 of 2020. Magnus, a live viable cellular allograft, and Cryo-Cord, a live cellular umbilical cord, were launched in the first quarter of 2020. Both products focus on providing live cellular therapies without the use of traditional toxic cyro-protectants. Both products are new, novel approaches to preserving live cells in a cryo-protected format.

Royal Biologic's FIBRINET is available for U.S. national distribution. Please contact [emailprotected] for more information.

1"Singlecenter, consecutive series study of the use of a novel plateletrich fibrin matrix (PRFM) and betatricalcium phosphate in posterolateral lumbar fusion," European Spine Journal https://doi.org/10.1007/s00586-018-5832-5, July 16, 2018.

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Royal Biologics Announces the Acquisition of FIBRINET - PRNewswire

Spinal Cord Stem Cells Comments Off on Royal Biologics Announces the Acquisition of FIBRINET – PRNewswire | September 1st, 2020