In BriefBioquark is about to begin a trial that will attempt to bringbrain-dead patients back to life using stem cells. However, thetrial is raising numerous scientific and ethical questions forother experts in the field. Back From The Dead

Researchers seem to be setting their sights on increasinglylofty goals when it comes to the human body from the worlds first human head transplant, to fighting aging, and now reversing death altogether. Yes, you read that right. A company called Bioquarkhopes to bring people who have been declared clinically brain-dead back to life. The Philadelphia-based biotech company is expected to start on the project later this year.

This trial was originally intended to go forward in 2016 in India, but regulators shut it down. Assuming this plan will be substantially similar, it will enroll 20 patients who will undergo various treatments. The stem cell injection will come first, with the stem cells isolated from that patients own blood or fat. Next, the protein blend gets injected directly into the spinal cord, which is intended to foster growth of new neurons. The laser therapy and nerve stimulation follow for 15 days, with the aim of prompting the neurons to make connections. Meanwhile, the researchers will monitor both behavior and EEGs for any signs of the treatment causing any changes.

While there is some basis in science for each step in the process, the entire regimen is under major scrutiny. The electrical stimulation of the median nerve has been tested, but most evidence exists in the form of case studies. Dr. Ed Cooper has described dozens of these cases, and indicates that the technique can have some limited success in some patients in comas. However, comas and brain death are very different, and Bioquarks process raises more questions for most researchers than it answers.

One issue researchers are raising about this study is informed consent. How can participants in the trial consent, and how should researchers complete their trial paperwork given that the participants are legally dead and how can brain death be conclusively confirmed, anyway? What would happen if any brain activity did return, and what would the patients mental state be? Could anything beyond extreme brain damage even be possible?

As reported by Stat News, In 2016, neurologist Dr. Ariane Lewis and bioethicist Arthur Caplan wrote in Critical Care that the trial is dubious, has no scientific foundation, and suffers from an at best, ethically questionable, and at worst, outright unethical nature. According to Stat News, despite his earlier work with electrical stimulation of the median nerve, Dr. Cooper also doubts Bioquarks method, and feels there is no way this technique could work on someone who is brain-dead. The technique, he said, relies on there being a functional brain stem one of the structures that most motor neurons go through before connecting with the cortex proper. If theres no functional brain stem, then it cant work.

Pediatric surgeon Charles Cox, who is not involved in Bioquarks work, agrees with Cooper, commenting to Stat News on Bioquarks full protocol, its not the absolute craziest thing Ive ever heard, but I think the probability of that working is next to zero. I think [someone reviving] would technically be a miracle.

Pastor remains optimistic about Bioquarks protocol. I give us a pretty good chance, he said. I just think its a matter of putting it all together and getting the right people and the right minds on it.

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Scientists Hope to Use Stem Cells to Reverse Death in ... - Futurism - Futurism

Spinal Cord Stem Cells Comments Off on Scientists Hope to Use Stem Cells to Reverse Death in … – Futurism – Futurism | June 2nd, 2017

These are indeed exciting times for spinal cord injury (SCI) clinical trials. There are trials ongoing around the world targeting different repair strategies. In this article we want to take the opportunity to explain some of the high profile clinical trials ongoing in the United States utilizing cells as a therapeutic intervention.

Miami Project Schwann Cells

As many of our readers know, The Miami Projects 1st Phase I clinical trial testing Schwann cells began in November 2012 and we are happy to announce that the final participant was transplanted in August 2015. Schwann cells come from your own body and they are a type of cell found throughout the entire peripheral nervous system (PNS). The PNS includes all nerves going out to muscles as well as sensory nerves coming from the muscles back to the spinal cord. Schwann cells are a type of support cell in the PNS and some important points about Schwann cells are that they 1) insulate (myelinate) individual nerve fibers (axons), which is necessary for sending appropriate electrical signals throughout the nervous system, 2) are not stem cells, they are adult cells and can only be Schwann cells, and 3) can be obtained from each persons own body thereby eliminating the need for immunosuppression medicine.

This trial is specifically targeting people with new SCI, less than 30 days after injury, having sustained a trauma-induced lesion between thoracic levels T3-T11 and whom were neurologically complete. This is a dose escalation treatment trial, meaning that we will test 3 different doses: 5 million, 10 million, and 15 million Schwann cells. There were a total of 39 people screened for eligibility, 9 were enrolled, and 6 participants were transplanted. The first two participants received the 5 million cell dose, the second two received the 10 million cell dose, and the final two received the 15 million cell dose. Thus far, there have been no treatment-related adverse effects in any of the transplanted subjects, which is excellent news. Remember, safety is the determinate of success for this phase I trial. We are not releasing any other information about the participants or results because the trial is still ongoing and we cannot compromise the data. After the final participant is 12 months post-transplant we will prepare the results for publication in a peer-reviewed scientific journal.

Our 2nd Phase I clinical trial began in February 2015 for chronic SCI and will also be primarily focused on safety, but in addition it will involve a preliminary evaluation of the efficacy of combining Schwann cells with exercise and rehabilitation. For humans with chronic SCI, we hypothesize that axons might show improved function if myelin repair is induced with the implantation of autologous Schwann cells. In addition, spinal cord cavitation may be reduced and neural sprouting and plasticity may be enhanced via neurotrophic effects. In this trial, participants will receive three months of fitness conditioning and locomotor rehabilitation prior to transplantation in order to validate the stability of their neurological baseline as well as to enhance their fitness level thereby reducing any deconditioning effects. They will also receive fitness conditioning and rehabilitation for six months post-transplantation to maintain health and promote neuronal activity and potential neuroplasticity. We believe that this combination of cell therapy with intense rehabilitation prior to and following cell transplantation will enhance our chances of seeing improved recovery in the chronic setting https://clinicaltrials.gov/ct2/show/NCT02354625 .

StemCells Inc

Drs. Allan Levi and Kim Anderson, along with several other University of Miami faculty members, are also participating in a clinical trial testing a different cell therapy neural stem cells. That trial, referred to as the Pathway Study, is sponsored by a company called StemCells, Inc.

The Pathway Study is testing the safety and potential benefit of a very specific stem cell type known as a neural stem cell; these are not Schwann cells. The neural stem cells being used in the Pathway Study were derived from fetal brain tissue and have the ability to self-renew and become the main types of mature cells found both in the brain and spinal cord. These cells do not come from your own body, therefore anyone who receives them into their body has to be on immunosuppression medicine. Studies of SCI in animals have shown that these human neural stem cells can survive and lead to recovery of function through remyelination and possibly neuronal cell replacement.

Prior to the Pathway Study, the company conducted a Phase I/II safety & preliminary efficacy clinical trial in humans with thoracic SCI. Twelve participants were transplanted within 3 to 12 months of injury. The results they have disclosed at scientific meetings indicate that neural stem cell transplantation appears to be safe; several participants have regained some sensation.

The Pathway Study is a larger Phase II efficacy clinical trial designed to determine if neural stem cells can help people with cervical SCI recover spinal cord function and gain strength and sensation. They will enroll up to 52 participants. Individuals may be able to join the study if they are 18 to 60 years old, have a cervical SCI that is classified as ASIA Impairment Scale grade A, B, or C, are less than two years post-injury, and are generally in good health. Individuals that are eligible for the study will participate for approximately 12 months. There are several sites around the country that are enrolling https://clinicaltrials.gov/ct2/show/NCT02163876 .

Asterias Biotherapeutics

Many of you have probably heard of the Geron clinical trial that was prematurely halted a few years ago for financial reasons. In 2013, a new company called Asterias Biotherapeutics took over the rights for everything related to the prior trial. The first trial was a Phase I safety trial using a human embryonic stem cell line pre-differentiated into oligodendrocyte progenitor cells. The oligodendrocyte progenitor cells are targeting reduction of the size of the injury cavity as well as remyelination of demyelinated axons to restore conduction. These cells also cannot be obtained from your own body, hence require immunosuppression medicine as well when administered to anyone. In that trial, 5 individuals with complete thoracic injury received the cells within 14 days after their injury. The results they have disclosed at scientific meetings indicate that the cell transplantation appears to be safe and that four of the five participants appear to have a smaller cavity when evaluated by MRI.

In 2015, they began a Phase I/IIa dose escalation trial, the SCI-Star study. This trial is enrolling individuals with cervical injury between levels C5-C7 whom are neurologically complete. The cells have to be injected between 14 to 30 days post-injury; up to 13 participants will receive the cells. There are at least 3 centers enrolling https://clinicaltrials.gov/ct2/show/NCT02302157 .

Neuralstem

The final cell therapy of high profile is being conducted by a company called Neuralstem. This is a Phase I safety trial using human fetal spinal cord neural precursor cells. These stem cells are targeting growth factor replacement and possibly neuronal cell replacement. Again, because these cells do not come from ones own body, they require immunosuppression medicine. The company previously completed a Phase I safety trial using the same cells in individuals with Lou Gehrigs disease. They transplanted 18 participants in mid- to late stages of the disease and demonstrated safety. The company then obtained approval for the SCI Phase I trial. A total of 4 participants with complete thoracic injury, between one and two years post-injury, will be transplanted. The study procedures are all performed in California https://clinicaltrials.gov/ct2/show/NCT01772810 .

To find out more information about the trials being conducted at The Miami Project, contact The Miami Project Education Department at 305-243-7108 or MPinfo@med.miami.edu . More information about all of our clinical trials and studies is available at http://www.themiamiproject.org/trials .

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A postdoctoral fellow will examine the protein's effects in human cells.

By Lawrence GoodmanJune 1, 2017

In ALS, also known as Lou Gehrigs disease, the bodys motor neurons degenerate and eventually die. As a result, muscles waste away, leading to an inability tospeak, move and, eventually, breathe. Patients typically die within five years of symptom onset.

One possible target for a drug treatment for ALS is the protein TDP-43. Mutations in the gene encoding TDP-43 cause some cases of inherited ALS and almost all sufferers of sporadic ALS to develop clumps of TDP-43 protein intheir neurons.

In recent years, postdoctoral fellow Mugdha Deshpande has been working withassociate professors of biology Avital Rodal and Suzanne Paradis to uncover how the TDP-43 protein damages neurons in model organisms such as the fruit fly Drosophila melanogaster. Now, they want to take the next step and see whether the same effects occur in human cells.

Deshpande is the Blazeman Postdoctoral Fellow for ALS Research, a position funded by the Rhode Island-based Blazeman Foundation for ALS. Based on her discoveries of how TDP-43 affects neurons in model organisms, she recently received a Brandeis Provost Research award to further her research on TDP-43 in human cells.

Deshpandes research focuses on motor neurons, whose nuclei are located in thespinal cord and whose nerve fibers, or axons, stretch throughout the body. In flies, defective TDP-43 has been shown to cause damage in the area where axonsconnect to muscles.

To test whether the same defects occur in humans, Deshpande will utilize a line of induced pluripotent stem cells isolated from an ALS patients skin cells and developed at the University of Massachusetts Medical School. In collaboration with the Human Neuron Core at Boston Children's Hospital, she will transform the stem cells into neurons.

Deshpande plans to study the defects that arise when human neurons develop whileharboring a genetic mutation in the TDP-43 gene. We need to gain an understanding of whats going on, she says. Without that, we are not going to get a therapy for ALS.

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Looking at the role of the protein TDP-43 in ALS - Brandeis University

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F

or any given medical problem, it seems, theres a research team trying to use stem cells to find a solution. In clinical trials to treat everything from diabetes to macular degeneration to ALS, researchers are injecting the cells in efforts to curepatients.

But in one study expectedto launch later this year, scientists hope to use stem cells in a new, highly controversial way to reverse death.

The idea ofthe trial, run by Philadelphia-based Bioquark, isto inject stem cells into the spinal cords of people who have been declared clinically brain-dead. The subjects will also receive an injected protein blend, electrical nerve stimulation, and laser therapy directed at the brain.

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The ultimate goal: to grow new neurons and spur them to connect to each other, and thereby bring the brain back to life.

Its our contention that theres no single magic bullet for this, so to start with a single magic bullet makes no sense. Hence why we have to take a different approach, said Ira Pastor, CEO of Bioquark.

A dogged quest to fix broken spinal cords pays off with new hope for the paralyzed

But the scientific literature scarce as it is seems to show that even several magic bullets are unlikely to accomplish what Bioquark hopes itwill.

This isnt the first start for the trial. The study launched in Rudrapur, India, in April 2016 but it never enrolled any patients. Regulators shut the study down in November2016 because, according to Science, IndiasDrug Controller General hadnt cleared it.

Now, Pastor said, the company is in the final stages of finding a new location to host trials. The company willannounce a trial in Latin America in coming months, Pastor told STAT.

If that trial mirrors the protocol for the halted Indian one, itll aim to enroll 20 patients wholl receive a barrage of treatments. First theres the injection of stem cells isolatedfrom the individuals own fat or blood. Second, theres a peptide formula injected into the spinal cord, purported to help nurture new neurons growth. (The company has tested the same concoction, called BQ-A, in animalmodels of melanoma, traumatic brain injuries, and skin wrinkling.) Third, theres a regimen of nerve stimulation and laser therapyover 15 days to spur the neurons to form connections. Researcherswilllook to behavior and EEG for signs that the treatment is working.

But the process is fraught with questions. How do researchers complete trial paperwork when the person participating is, legally, dead? (In the United States, state laws most often define death as the irreversible loss of heart and lung or brain function.) If the person did regain brain activity, what kind of functional abilities would he or she have? Are families getting their hopes up for an incredibly long-shot cure?

Answers to most of those questions are still far off. Of course, many folks are asking the what comes next? question, Pastor acknowledged. While full recovery in such patients is indeed a long term vision of ours, and a possibility that we foresee with continued work along this path, it is not the core focus or primary endpoint of this first protocol.

No real template exists to know whether this approach might work and its gotten some prominent backlash. Neurologist Dr. Ariane Lewis and bioethicist Arthur Caplan wrote in a 2016 editorial that the trial borders on quackery, has no scientific foundation, and gave families a cruel, false hope for recovery. (Exploratory research programs of this nature are not false hope. They are a glimmer of hope, Pastor responded.)

The company hasnt tested the full, four-pronged treatment, even in animal models. Studies have evaluated the treatments singly for other conditions stroke, coma but brain death is a quite different proposition.

Stem cell injections to the brain or spinal cord have shown some positive results for children with brain injuries; trials using similar procedures to treat cerebral palsy and ALS have also been completed. One small, uncontrolled studyof 21 stroke patients found that they recoveredmore mobility after they received an injection of donor stem cells into their brains.

On transcranial laserdevices, the evidence is mixed. The approach has been shown to stimulate neuron growth in some animal studies. However, a high-profile Phase 3 study of one such device in humans was halted in 2014 after it showed no effect on 600 patients physical capabilities as they recovered from a stroke. Othertrialsto revive people from comasusing laser therapy are underway.

The literature around electrical stimulation of the median nerve whichbranches from the spinal cord downthe arm and to the fingers primarily consists of case studies.Dr. EdCooper wrote some of those papers, one of which described dozens of patients treated in his home state of North Carolina, including 12 who had a Glasgow Coma Score of 4 an extremely low score on the scale. With time (and with the nerve stimulation), four of those 12people made a good recovery, the paper described; others were left with minor or major disabilities after their coma.

Mini-me brains-in-a-dish mimic disease, raise hope for eventual therapies

But Cooper, an orthopedic surgeon by training who worked with neurosurgeons on the paper, said unequivocally that there is no way this technique could work on someone who is brain-dead. The technique, he said, relies on there being a functional brain stem one of the structuresthat mostmotor neurons go through before connecting with the cortex proper. If theres no functional brain stem, then it cant work.

Pastor agreed but heclaimed the technique would work because there are a small nestofcells that still function in patients who are brain-dead.

Complicating such trials, there is noclear-cut confirmatory test for brain death meaning a recovery in the trial might not be entirely due to the treatment. Some poisons and drugs, for instance, can make people look brain-dead.Bioquark plans to rely on local physicians in the trials host country to make the declaration. Were not doing the confirmatory work ourselves, Pastor said, but each participant would have undergone a battery of tests considered appropriate by local authorities.

But asurvey of 38 papers published over 13 years found that, if the American Academy of Neurology guidelines for brain death had been met, no brain-dead people have ever regained brain function.

Of Bioquarks full protocol, its not the absolute craziest thing Ive ever heard, but I think the probability of that working is next to zero, said Dr. Charles Cox, a pediatric surgeon who has doneresearch with mesenchymal stem cells the type used in the trial at the University of Texas Health Science Center at Houston. Cox is not involved in Bioquarks work.

Some studies have found that cells from a part of thebrain called the subventricular zone can grow in culture even after a person is declared dead, Cox said. However, its unlikely that the trials intended outcome to havea stem cell treatment result in new neurons or connections would actually happen. Neurons would likely struggle tosurvive, because blood flow to the brain isalmost always lostin people whohave been declared brain-dead, Cox said.

But Pastor thinksBioquarks protocol will work. I give us a pretty good chance, he said. I just think its a matter of putting it all together and getting the right people and the right minds on it.

Cox is less optimistic. I think [someone reviving] would technically be a miracle, he said. I think the pope would technically call that a miracle.

Kate Sheridan can be reached at kate.sheridan@statnews.com Follow Kate on Twitter @sheridan_kate

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Resurrected: A controversial trial to bring the dead back to life plans a restart - STAT

Spinal Cord Stem Cells Comments Off on Resurrected: A controversial trial to bring the dead back to life plans a restart – STAT | June 2nd, 2017

Genetically and immune-mediated disease, Multiple Sclerosis symptoms and progression are unpredictable at the time of diagnosis.

Multiple Sclerosis is an inflammatory disease that affects the brain and spinal cord of an individual. It occurs due to the combination of genetic susceptibility and can also occur due to low vitamin levels, virus, and environmental factors. The Multiple Sclerosis Foundation estimates that more than 400,000 people in the United States and about 2.5 million people around the world have Multiple Sclerosis. No large epidemiological studies have been reported from India but calculations based on hospital data in the 1970s suggested an approximate prevalence rate of only 0.17 to 1.33 per 100,000 in different parts of India. Increased awareness and the rise in the number of neurologists and availability of MRI has led the current estimates to about 7 to 10 per 100,000. As there are many Indians who still do not have access to adequate medical facilities especially in the rural sector, there can be a rise in the figures mentioned too. As per hospital-based studies within India, an increase in the incidence of Multiple Sclerosis from 1.58% to 2.54% has been noted in the last decade.

This immune-mediated disease affects the protective covering (myelin sheath) around the nerves which result in neurological defects. With the help cellular therapy, utilising the various properties of stem cells, Multiple Sclerosis can be treated. In autologous cell-based therapy, stem cells from the patients own body are transplanted, which resets the immune system. A patient suffering from Multiple Sclerosis is often treated with immune-suppressive drugs and monoclonal antibodies. But, these agents are associated with side effects with long-term use and are not entirely effective in managing symptoms. Autologous stem cells are neuroprotective and also have other paracrine properties by which patients of Multiple Sclerosis can benefit. The immunomodulatory properties of the stem cells help reduce damage in the central nervous system of patients with Multiple Sclerosis. It also helps in regeneration of the injured nerves, said Dr Pradeep Mahajan, Regenerative Medicine researcher at StemRx Bioscience Solutions Pvt. Ltd.

The time taken to heal varies from patient to patient and can go from 2 months to 1 year. There are various ways to administer the stem cells back into the body, the route depending on the condition and requirement of the patient. In neurological conditions, the appropriate route of administration would be the one which facilitates cell delivery into the brain.

Published: May 30, 2017 4:09 pm | Updated:May 30, 2017 4:10 pm

Disclaimer: TheHealthSite.com does not guarantee any specific results as a result of the procedures mentioned here and the results may vary from person to person. The topics in these pages including text, graphics, videos and other material contained on this website are for informational purposes only and not to be substituted for professional medical advice.

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World Multiple Sclerosis Day 2017: Cellular Therapy helps induce long-term remission of Multiple Sclerosis - TheHealthSite

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TROY, Mich., May 30, 2017 /PRNewswire/ --Jay Jagannathan, M.D., known as one of the United States' top neurosurgeons, was featured on WJR AM-760 radio show Anything is Possible! hosted by Jack Krasula on May 27, 2017. During the one-hour show, Dr. Jagannathan discussed the importance of patient-centric care in spine surgery. "It is important that patients know the full spectrum of surgical and non-surgical options," he said, adding that "a full understanding of their options puts patients in a position to make the best decision for themselves."

When asked by Jack Krasula show about the future of spine surgery, Dr. Jagannathan specifically pointed to motion-sparing techniques. Motion-sparing techniques aim to preserve motion in the spine, and are increasingly relevant given the recent FDA approval of 2-level cervical artificial disks. "The idea of preserving motion will permit many patients who were not previously candidates for spine surgery to have procedures that can help with pain while still maintaining normal spinal motion and hopefully reducing the future need for re-operation," he said. Dr. Jagannathan also discussed the importance of stem cells, which are undifferentiated, primitive cells that have the capability of maturing into specific tissue types. According to Dr. Jagannathan, "stem cells not only have the ability to possibly enhance spinal fusion outcomes, but also to serve as a vector to induce healing following spinal cord injury or stroke." Dr. Jagannathan also pointed to the advances in imaging modalities and technology, which has allowed surgeons to provide minimally invasive treatment for pathology which previously were untreatable. "What MIS has taught us is that using image-guided targeting while decreasing tissue manipulation can greatly reduce post-operative pain, hospital stays and post-operative drug use."

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Neurosurgeon Dr. Jay Jagannathan discussed the future of spine surgery, motion-sparing techniques and minimally ... - PR Newswire (press release)

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New York Times

A New Drug for ALS, but the Diagnosis Remains Dire New York Times A.L.S. attacks the nerve cells in the brain and spinal cord that control voluntary muscle movements, like chewing, walking, breathing, swallowing and talking. It is invariably progressive. Lacking nervous system stimulation, the muscles soon begin to ...

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Uproxx knows that science, technology, engineering, and math (STEM) disciplines are driving the future of this planet forward. Every day, we see new ideas, fresh innovations, and bold trailblazers in these fields. Follow us this month as we highlight how STEM is shaping the culture of NOW.

Placentas, umbilical cords pretty much anything that comes out of a womans body is awesome in science speak. Stem cells are the master cells of the body, just waiting to help you out when you get sick. Theyre your own personal repair kit, but, like anything, time kind of screws them up. They become damaged or mutated thanks to environmental factors and the aging process and one day, they lose their incredible healing abilities altogether.

The good news is, science has finally tapped into the potential of stem cell research and, in doing so, scientists have found a solution for all that wasted power: babies. Yes, babies are disgusting blobs that poop, eat, and slobber their parents to an early grave, but those little devils also just happen to have a whole army of brand new stem cells still in their original packaging. The key is to get them before they sell out. (Im starting to equate body parts with consumerism and its getting creepy so Ill stop now.)

Placenta blood, placenta tissue, and cord blood are three sources of stem cells doctors are urging new parents to consider saving after the mom gives birth. They provide a range of cool benefits from treating certain forms of cancer to helping people heal from spinal cord injuries and they can be cryogenically frozen to help a body out whenever it needs some extra healing power. And yes, some people do eat them. Google it, there are recipes.

But while the placenta party has been raging for a while now, theres a new method of extracting stem cells that can be done all the way up into a persons teen years, and all it takes is a quick trip to the dentist. Tooth banking has become the latest way people are choosing to cryogenically secure their gene sequence.

In 2013, Songtao Shi, a dentist, was researching regenerative dentistry in a lab when Shi witnessed something extraordinary. He discovered that when you get a cavity, the dentin the inner, hard layer of your tooth that protects the nerve and pulp from exposure builds up. Basically, your tooth tries to protect itself by making more organic matter.

This led Shi to conclude that stem cells did, in fact, exist in teeth. A bit more study found that while stem cells in adult molars were able to create more dentin which is great if you want to re-grow lost teeth instead of paying a fortune for an implant baby teeth, or SHED cells (stem cells from human exfoliated deciduous teeth) contained a whole different set of code.

While cord blood and placenta tissue contain Hematopoietic stem cells which have been used for decades to treat over 80 different diseases, SHED cells contain mesenchymal stem cells which differentiate into nerve cells as well as bone, cartilage, muscle, and fat. Cord blood contains mesenchymal stem cells too, but according to Shis research, SHED cells were able to create something unusual, dentin osteogenic material a material thats not quite dentin, not quite bone but full of possibilities like the ability to reconstruct bone.

Extracting dental stem cells is a complicated and sensitive process. First, the soft tissue has to be extracted, then it has to be disinfected (spoiler alert: your mouth is a cesspool of germs). Scientists then drill through the enamel and dentin to get to the pulp of the tooth where all the stem cells like to hide out. They take the pulp out, digest it with an enzyme, and culture the cells.

Its a lot of work, but the payoff is huge. Even tiny bits of dental pulp can carry hundreds of millions of stem cells.

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Why Tooth Banking Might Just Be The Next Wave In Stem Cell ... - UPROXX

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26 May 2017

Could tyrosine kinase inhibitors, a standard tool of cancer treatment, help people with amyotrophic lateral sclerosis? Converging evidence suggests that this drug class may slow ALS progression, perhaps through multiple mechanisms. In the May 24 Science Translational Medicine, researchers led by Haruhisa Inoue at Kyoto University, Japan, report that numerous different inhibitors of the tyrosine kinases Src and c-Abl improve the survival of motor neurons from ALS patients. The compounds act by stimulating autophagy, which accelerates the removal of toxic proteins. One of the most potent inhibitors, bosutinib, boosted motor neuron survival by 50 percent and modestly lengthened the lives of ALS model mice, the authorsreport.

In related news, researchers recently reported positive findings from a Phase 3clinical trial of another tyrosine kinase inhibitor, masitinib, at the European Network for the Cure of ALS (ENCALS) annual meeting, held May 18 to 20 in Ljubljana, Slovenia. This inhibitor, which is approved to treat tumors in animals but not people, reportedly doused neuroinflammation in the spinal cord. Patients on the drug maintained motor abilities four months longer than did those on placebo, a statistically significant improvement. AB Science in Paris, the manufacturer, has applied to the European Medicines Agency for approval to use the drug in people, and is planning to start another Phase 3trial this year before applying for approval from the U.S. Food and DrugAdministration.

The data suggest that tyrosine kinase inhibitors might help in other neurodegenerative diseases such as Alzheimers and Parkinsons, which also accumulate toxic proteins and cause neuroinflammation, said Charbel Moussa at Georgetown University, Washington, D.C. He noted that many of these compounds are already FDA-approved for other conditions, and can be used at much lower doses for neurodegenerative disease than for cancer. These drugs represent a promising alternative to antibody and vaccination strategies, he told Alzforum. He was not involved in either of thesestudies.

ALS in a Dish. Stem cells derived from people with familial ALS differentiate into neurons in culture that express motor neuron markers HB9, ChAt, and SMI-32. Nuclei are stained blue. [Courtesy of Science TranslationalMedicine/AAAS.]

The need for new drugs for ALS is immense. In this devastating disease, spinal motor neurons wither, robbing people of motor control and killing them typically within three to five years. Approved treatments are limited to riluzoleand edaravone, which was just approved in the U.S. this month (see May 2017 news). Both modestly slow functional decline, though efficacy data for edavarone remains sparse. Researchers are still seeking betteroptions.

To cast a wider net, Inoue and colleagues screened 1,416 compounds that are either approved for human use or in clinical trials. First author Keiko Imamura generated induced pluripotent stem cells (iPSCs) from a single ALS patient who carried a SOD1 mutation. The authors differentiated these cells into spinal motor neurons and cultured them for seven days, added the compounds, and assessed survival one week later. In this screen, 27 compounds boosted survival more than three standard deviations above that of untreated cells. Half of these compounds targeted the Src/c-Abl signaling pathway. These cytosolic tyrosine kinases participate in numerous cellular processes and are implicated in cancer. To confirm these enzymes mediated the drug effect, the authors knocked down Src and c-Abl with short interfering RNAs, and again saw improved motor neuronsurvival.

Among the hits, the authors selected bosutinib for follow up. This drug is approved to treat chronic myelogenous leukemia, directly inhibits Src and c-Abl, and acts at lower doses than the other compounds in the screen. Bosutinib normalized autophagy in the diseased motor neurons. Compounds that blocked autophagy weakened the protective benefits of bosutinib, suggesting this was its mechanism of action. In keeping with this, other known autophagy boosters, such as rapamycin, also improved motor neuron survival. As might be expected, revving up autophagy cleaned up deposits of misfolded, toxic SOD1. The authors did not detail how inhibition of Src and c-Abl stimulated autophagy, but other work provides clues. Moussa and colleagues have reported that c-Abl inhibition activates the ubiquitin ligase parkin, which then interacts with autophagy proteins such as beclin-1 to stimulate degradation of proteins including A and -synuclein (see Lonskaya et al., 2013; Lonskaya et al., 2014; Wenqiang et al., 2014). A sister compound to bosutinib, nilotinib, is currently in Phase 2 trials for PDand ADthat Moussa and colleagues at Georgetown are running (see Nov 2015 conference news).

Only 2 percent of people with ALS carry SOD1 mutations. What about other forms of the disease? To expand their study, the authors generated motor neurons from three ALS patients with TDP-43 mutations, three with C9ORF72 expansions, and three with sporadic disease. Most people with ALS, regardless of their mutation status, accumulate misfolded TDP-43, and C9ORF72 is the most common familial mutation. In this study, bosutinib lowered levels of misfolded TDP-43 and poly dipeptide repeats formed from the C9ORF72 expansion; it also improved survival in all cell lines save for one from a sporadiccase.

Next, the authors tested bosutinib in the SOD1-G93A mouse model of ALS. These animals become paralyzed at four and die by six months of age. The authors injected a single dose, 5 mg/kg/day, intraperitoneally for six weeks beginning at two months of age. Src and c-Abl activity in the spinal cord was cut in half, indicating target engagement. Treated mice accumulated slightly less misfolded SOD1 and had about three times as many surviving motor neurons in their spinal cords as untreated ones. Nevertheless, treatment delayed disease onset by only 11 days and extended survival by just eightdays.

Why didnt the drug work better in mice, given the promising in vitro data? Nonneuronal cells such as astrocytes contribute to ALS pathology, but Inoues screen did not test for effects of bosutinib on these cells (e.g. Oct 2014 news; Nov 2014 news). In an email to Alzforum, Inoue also suggested that bosutinib could be optimized to better enter the brain and avoid potential off-target effects. Peter Davies at the Feinstein Institute for Medical Research in Manhasset, New York, pointed out that tyrosine kinase inhibitors such as bosutinib are typically not specific for c-Abl. I would like to see pharma make more specific compounds, because then we would learn if the key factor really is c-Abl, rather than another kinase, and there would be fewer off-target effects, Davies wrote to Alzforum. He acknowledged that making specific c-Abl inhibitors is a challenging task, and that companies have tried and abandoned some past efforts for lack ofsuccess.

The findings from bosutinib and nilotinib complement those for masitinib. This veterinary drug seems to act mostly on immune cells. Preclinical studies suggested masitinib inhibits the tyrosine kinases CSF-1R and C-kit in microglia, macrophages, and mast cells, circulating white blood cells that trigger allergic and inflammatory reactions. In animal models, masitinib prevents microgliosis and astrogliosis in the spinal cord, as well as the infiltration of mast cells and macrophages into neuromuscular junctions (see Trias et al., 2016). This provides a rational basis for the protective effects of masitinib in delaying neuromuscular junction denervation. However, more research is needed to understand the detailed mechanism of action of the drug, Luis Barbeito at the Pasteur Institute of Montevideo, Uruguay, wrote to Alzforum. Barbeito presented preclinical data on masitinib atENCALS.

In the Phase 3 trial, 394 patients from nine countries took either 4.5 mg/kg masitinib, 3 mg/kg, or placebo for nearly a year. By prespecified plan, the researchers stratified participants into fast progressors (those who declined more than 1.1 point per month on the revised ALS Functional Rating Scale) and normal progressors. About 85 percent of the participants were normal progressors. Among this group, those taking 4.5 mg/kg masitinib declined 3.4 points less on the ALSFRS-R than the placebo group over the course of the study. This translated to 27 percent less functional decline over this time period, a clinically meaningful difference, according to Jesus Mora at Hospital Carlos III in Madrid, who presented the clinical trial findings at ENCALS. Treated participants maintained greater lung capacity and reported better quality of life than the placebo group. They lasted 20 months before their disease progressed nine points or more on the ALSFRS-R, compared with 16 months for those on placebo. Participants who took the lower 3 mg/kg dose also reported better quality of life, but their trend toward slower functional decline did not reachsignificance.

Other data hinted that the drug was most effective when given at an early stage of disease. When normal and fast progressors were combined, the 4.5 mg/kg dose only slowed decline in those who had had the disease for less than two years. Fast progressors may need earlier treatment, Morasuggested.

The safety profile was acceptable, with no surprises cropping up, the researchers said. The treatment group experienced more serious adverse events than the placebo group. These were scattered across different organ systems and did not fall into any pattern. For oncology use, tyrosine kinase inhibitors are normally given at higher doses, from 6 to 12 mg/kg, with no serious safety issues, the researchers noted.Madolyn BowmanRogers

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Do Some Cancer Drugs Offer Hope for ALS Therapy? | ALZFORUM - Alzforum

Spinal Cord Stem Cells Comments Off on Do Some Cancer Drugs Offer Hope for ALS Therapy? | ALZFORUM – Alzforum | May 27th, 2017

"The practice of helping babies by providing stem cells at birth has been around for a long time; it makes sense for the sickest infants," said Anup Katheria, MD, director of the Neonatal Research Institute. "We're focused on producing evidence that shows the benefits. We think this could become the foundation for practice-changing birthing techniques, transforming outcomes for the most critical of newborns nationwide."

As a California-based public/private cord blood banking company and with a strong research focus, StemCyte stands ready to help efficiently and effectively to support the partnership with Sharp HealthCare to educate expecting parents of their options, to ensure the information is delivered accurately and consistently, and to collect the cells in cord blood and process and store them with the highest quality standards in the industry.

"We are excited to work with the Sharp Mary Birch Neonatal Research Institute, and we are looking forward to maximizing the capacity for cord-blood banking. Residents of California and people around the world will benefit from the research and increased availability of umbilical cord blood stem cell transplant units." said Jonas C. Wang, Ph.D., CEO/ Chairman of StemCyte Group.

About StemCyte StemCyte's rich history started with a mission of being dedicated to helping the world's physicians save more lives by providing high quality, safe and effective stem cell transplantation and therapy to all patients in need. Located in the US, India and Taiwan, StemCyte has supplied over 2100 cord blood products for over 40 life-threatening diseases to over 300 leading worldwide transplant centers. StemCyte is actively involved in the development of stem cell therapies. StemCyte was the first to donate umbilical cord blood units (UCB) to Dr. Jaing of Chung Gung Memorial Hospital for his clinical trial to use UCB to treat and cure Beta Thalassemia. More excitingly is the work and accomplishments of Prof Wise Young, MD, PhD. Prof. Young has completed Phase II clinical trials on patients with chronic spinal cord injury with UCB and the results are extremely encouraging. StemCyte is chosen by the US Department of Health and Human Services to help establishing a public National Cord Blood Inventory. Its headquarters are located in Baldwin Park, CA. To learn more visit http://www.StemCyte.com.

For more information call 626.646.2500

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/stemcyte-renewed-strategic-partnership-with-the-neonatal-research-institute-at-sharp-mary-birch-hospital-for-women--newborns-300464844.html

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StemCyte renewed strategic partnership with the Neonatal Research Institute at Sharp Mary Birch Hospital for Women ... - PR Newswire (press release)

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41 NBC News

Conservative Reps Urge Trump to Fire NIH Head - WMGT 41 NBC News Stem Cell Research.Experimenting with cells in petri dish by adding fluid from a pipette, used in therapeutic cloning, microbiology, genetic engineering an. and more »

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Researchers in the U.K. are set to test whether the Zika virus can fight difficult-to-treat brain cancer by attacking its cells, potentially opening up new pathways to treat the aggressive disease. Researchers will focus on glioblastoma, which is the most common form of brain cancer and has a five-year survival rate of 5 percent, Reuters reported.

QUINOA 'MILK' DIET KILLED BABY, AUTHORITIES SAY

The Zika virus causes severe birth defects in an unborn fetus when contracted during pregnancy by attacking developing stem cells in the brain. However, the disease does not have the same devastating effect on fully developed brains, suggesting that if scientists can harness the virus ability to attack the cancer cells, which are similar to developing brain stem cells, healthy brain tissue will go unharmed.

Were taking a different approach, and want to use these new insights to see if the virus can be unleashed against one of the hardest-to-treat cancers, Harry Bulstrode, a lead researcher at Cambridge University, said, in a statement to Reuters.

ITALY VOTES TO MAKE VACCINES MANDATORY

Researchers will use tumor cells in mice to test the virus, and hope that it will slow tumor growth.

If we can learn lessons from Zikas ability to cross the blood-brain barrier and target brain stem cells selectively, we could be holding the key to future treatments, Bulstrode told Reuters.

Active outbreaks of the mosquito-borne illness were reported in at least 51 countries and territories, with pregnant women advised to avoid travel to so-called virus hotbeds. In addition to birth defects, Zika has been associated with neurological disorders including brain and spinal cord infections. Long-term health consequences remain unclear.

Reuters contributed to this report.

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Researchers consider Zika virus for brain cancer treatment - Fox News

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From hopeless to a miracle: How he got his life back after a crash left him paralyzed fox6now.com "We came to know he would be a good candidate for this regenerative treatment that we offer, meaning the stem cell injection into the spinal cord. ... "He was only the second to receive the stem cells -- at least that dose he received," added Dr. Kurpad.

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From hopeless to a miracle: How he got his life back after a crash left him paralyzed - fox6now.com

Spinal Cord Stem Cells Comments Off on From hopeless to a miracle: How he got his life back after a crash left him paralyzed – fox6now.com | May 19th, 2017

In 2004 California ballot measure Proposition 71 was passed, granting $3 billion ($6 billion including interest) in state funds to support politically controversial embryonic stem cell research in California at a time when the federal government was restricting this research. A public agency was established, the California Institute for Regenerative Medicine, to dole out this money across California universities, medical research institutions and biotech companies. During the election campaign, California voters were assured of breakthroughs and cures for conditions like Parkinsons and spinal cord paralysis through celebrity endorsements featuring actors, Nobel prize winners and other notables. Prop. 71 money is dwindling and there is talk about putting a $5 billion renewal initiative on the ballot. So its reasonable to ask what California taxpayers got out of this deal over the past 13 years. Sadly, CIRM hasnt generated a single approved medical treatment. Through September 2016, CIRM has funded only three stem cell research projects that have reached Phase 3 clinical trials (the final step before FDA marketing approval). One of these trials was terminated and the other two are still recruiting patients and are not expected to report out for several years. During the same time, despite embryonic stem cell research restrictions, the federal National Institutes of Health has funded 50 stem cell research projects in Phase 3 trials. The NIH cost per Phase 3 research trial has been five times lower than the state program. Nearly half of the state funding has gone to research infrastructure rather than to actual research.

There also appears to have been blatant conflicts of interest in CIRM research awards. Around 80 percent of CIRM grants have gone to institutions represented on its board of directors. One out of seven CIRM research dollars has gone to Stanford University. One awardee, StemCells Inc., was co-founded by Irving Weissman, Stanfords stem cell program director. StemCells received at least $40 million from CIRM before going belly up. The CIRM board initially turned down a $20 million funding proposal to StemCells, until Bob Klein, the Northern California real estate investor who drafted Prop. 71 and was the first chairman of CIRMs governing board, was reported to have pressured the board to reverse that decision. CIRMs President Alan Trounson abruptly resigned in October 2013, joined the board of StemCells one week later, and then received $435,000 in cash and stocks from them before the company folded last year.

Does it make sense for California taxpayers to fund biotechnology research? Perhaps. A good case can be made that public investments in basic biotechnology infrastructure can have enormous benefits to Californias economy and job growth while generating significant improvements in human health. But public funding should have broader scope and flexibility to go after all promising new technological advances, not just current scientific fads or political controversies. Public funds should be awarded with rigorous oversight and accountability. There should be a sharp line between basic research, which requires public funding and is unlikely to yield short-term tangible cures, despite what celebrity actors say, and getting new medicines to market. Promising new treatments are already well-funded through private venture capital funds and biotech companies, who are much better at picking winners and losers than California taxpayers.

By not providing adequate oversight over potential conflicts of interest and not holding CIRM funding recipients to the same rigorous standards as NIH grant recipients, CIRMs 13 year record of zero new medicines for $6 billion in taxpayer funds is not an experiment that the voters should regenerate at the ballot box.

Joel W. Hay is a professor of Health Economics and Policy at the University of Southern California.

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Regenerating medical research payouts? - OCRegister

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Neuralstem Cell Therapy:

Different regions of the brain and spinal cord house different, specialized cells. Neuralstem's technology enables the isolation and expansion of human neural stem cells from each of these regions of the developing central nervous system (CNS) in virtually unlimited numbers from a single donated tissue.

The goal of cell therapy is to replace and/or repair dead or diseased cells. Unlike other stem cell technologies, Neuralstem is growing regionally specific cells that are already suited to the task prescribed to them once transplanted into the CNS. In spinal cord indications, for instance, the company will be using human NSI-566 spinal cord stem cells only. Additionally, once inside the body, Neuralstem cells also do not become any cell other than that to which they are fated.

There are two primary ways that these cells can provide therapeutic effects. Create: The transplanted cells may help create new circuitry Express: The transplanted cells may express factors that protect existing cells

We believe that Neuralstem's cells do both.

In preclinical work conducted at major research centers across the U.S., Neuralstem cells integrated and made synaptic contact with the host. The cells also expressed one or more growth factors. These are special chemicals that the CNS uses to operate and thrive. Many of these growth factors are protective of cells. View published papers here: 1, 2, 3.

Neuralstems transplanted cells survive in patients and integrate into the host tissue, creating new circuitry and expressing growth factors. This dual function is important. In spinal cord injury, for instance, the company hopes to create circuitry that will help signals from the brain get to where they need to go. In many indications, the goal is to slow down or halt the degeneration of cells caused by disease, or by injury, by expressing neuroprotective growth factors into the system.

A vital component to the Neuralstem cell therapy platform is the delivery of the cells directly into the gray matter of the spinal cord, where they can protect and integrate with the patient's spinal cord neurons.

Neuralstem's proprietary Spinal Cord Delivery Platform and Floating Cannula were designed specifically by Neuralstem's ALS trial neurosurgeon, Nicholas M. Boulis, MD, for the world's first intraspinal delivery of stem cells. The safety of the device was first reported in data presented at the American Association of Neurologists' 2011 Annual Meeting, and its safety has since been repeatedly validated in the companys completed two ALS clinical studies, in a total of thirty patients, which met primary safety endpoints. In addition to ALS, NSI-566 is also in a Phase I trial in chronic spinal cord injury at UC San Diego School of Medicine. You can view this breakthrough medical device in surgery here.

The Spinal Cord Delivery Platform and Floating Cannula will be utilized to deliver Neuralstem cells in the spinal cord safely and effectively for myriad diseases and injuries. Expected to be the standard in the industry and research community for intraspinal procedures, Neuralstem is licensing the breakthrough cell therapy device to industry and academia.

Delivery of neural stem cells into the brain will be accomplished using well-established stereotactic injection procedures. NSI-566 is in clinical development to treat ischemic stroke utilizing one-time treatments of these intracerebral injections to safely transplant cells near the stroke lesions of ischemic stroke patients.

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Repairing and Replacing Damaged Cells - Neuralstem

Spinal Cord Stem Cells Comments Off on Repairing and Replacing Damaged Cells – Neuralstem | May 15th, 2017

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National Multiple Sclerosis Society Commits to $17 Million for 43 Research Projects - Multiple Sclerosis News Today