GABRIELLA FIORINO

We trust our doctors with our lives. However, what is the reaction when some medical professionals allow unsanitary measures and diseases to break out into the population? Four institutions in the U.S. came under fire recently by the FDA for improperly handling microbiological organisms and exposing the public to smallpox after conducting unapproved techniques, endangering hundreds of lives.

The FDA identified four medical centers in California and Florida as utilizing unapproved stem cell therapies for those with cancer and other serious illnesses. One of the institutes, California Stem Cell Treatment Centers, applied a method developed by StemImmune Inc., which consisted of injecting clients with a mixture of the smallpox vaccine and stem cells. Dr. Mark Berman, co-founder of the California center, described their methods as cutting edge therapy for stage-4 cancer patients, as reported by the Los Angeles Times.

The consequences of such methods are worrisome; as the FDA claims exposure to the smallpox vaccine significantly increases the risk of life-threatening complications, including heart inflammation. Perhaps even more troubling is the fact that individuals in contact with those receiving the vaccine may develop similar symptoms, possibly infecting hundreds of others. The FDA is currently investigating how StemImmune Inc. received shipments of the vaccine, as the product is unavailable on the market.

The Stem Cell Clinic of Sunrise, Florida is another facility under investigation by the FDA for taking improper sanitary measures to prevent contamination during their therapies. According to the agency, the clinic refused to permit entry of an FDA inspector without an appointment, which is a violation of federal law. This refusal would not be the first time the Florida institution came under fire. According to the New England Journal of Medicine, three clients suffering from macular degeneration sustained blindness following treatment at the facility.

A variety of sources derive stem cells, including bone marrow, blood, umbilical cords, and controversially, human embryos. These products aid in the development and restoration of healthy human tissue, and help battle cancer, heart disease, and Parkinsons disease, as noted by the University of Utah. These products are also employed for spinal cord injuries, indicating critical applications, as the central nervous system does not naturally permit neuro-regeneration following damage. Excitingly, organs growth for those requiring life-saving transplants is another possible advancement.

These innovations are not without consequences, however. According to the Mayo Clinic, some may develop graft-versus-host disease, a condition in which a donors stem cells attack the patients tissues and organs, possibly leading to death. Risks of brain tumor development are also an increased possibility for those receiving injections in the spinal cord, as abnormal tissue growth may result.

As the FDA investigates unsound practices by the four institutes endangering the lives of hundreds, Americans should not be misled regarding stem cell therapies. Through proper sanitary measures, their uses are a huge medical development, comprising a myriad of medical advantages. Liberty Nation will keep readers up to date regarding the actions of the FDA against the four clinics.

Gabi is a Biomedical Sciences major and manages a Cognitive Neuroscience Research Lab at the University of Central Florida. A Libertarian, Gabi says shes surrounded on by whiny, wannabe anti-capitalists, posting about their victimhood on Facebook.Although leftists often confuse her with privileged white girls, Gabi is Puerto Rican and Italian.Make sense of that, liberals!

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Stem Cells and "Mishandling" Smallpox - Liberty Nation - Liberty Nation (registration) (blog)

Spinal Cord Stem Cells Comments Off on Stem Cells and "Mishandling" Smallpox – Liberty Nation – Liberty Nation (registration) (blog) | September 3rd, 2017

01 Sep 2017

A paper in the September 1 Nature claims a cadre of rogue microglia are all it takes to orchestrate neurodegeneration. Researchers led by Frederic Geissmann and Omar Abdel-Wahab of Memorial Sloan Kettering Cancer Center in New York, and Marco Prinz of the University of Freiburg in Germany, induced a somatic mutation in about 10 percent of microglia that switched on ERK kinase signaling. The mice later developed a severe neurodegenerative disease that paralyzed them. The researchers determined that damaging inflammation caused by the mutated microglia was likely to blame. The findings raise the possibility that similar somatic mutations in people are responsible for a rare neurodegenerative disease that occurs inchildren.

This is a great paper for many reasons, commented Bart De Strooper of the Dementia Research Institute in the U.K. I am particularly excited about the concept of acquired genetic mosaicism as a cause of neurodegenerative disorder. The paper also shows that microglia mutations can be directly causative inneurodegeneration.

Most famous for their role in causing cancer, somatic mutations can spontaneously arise in any cell, sometimes giving it a proliferative edge. Mutations in the RAS-MEK-ERK signaling pathway, for example, can cause diseases called histiocytoses if they arise in the myeloid cell lineage, which gives rise to blood and immune cells, including macrophages and microglia. Histiocytoses manifest in different ways, including leukemias, other tumors, and malfunctions in multiple organs. Mysteriously, a small fraction of carriers also get a neurodegenerative disease that manifests between childhood and middle age, with symptoms such as cerebellar ataxia and tremor (Lachenal et al., 2006; Wnorowski et al., 2008). The reason for the neurodegeneration has been amystery.

Geissmann and colleagues speculated it could be caused by microglia descended from erythro-myeloid progenitor cells (EMPs) harboring the same RAS-MEK-ERK somatic mutations. EMPs arise in the embryonic yolk sac early in development, and give rise to microglia in the brain and macrophages in other tissues (Perdiguero et al., 2014; Feb 2015 conference news).In contrast, circulating monocytes are continually replenished by hemotopoietic stem cells (HSCs) in the bonemarrow.

Doomed During Development? Histiocytoses arise from somatic mutations in hematopoietic stem cells (HSCs, left) or in erythro-myeloid progenitor (EMP) cells (right), which give rise to macrophages and microglia. The mutant microglia may cause inflammation, leading to neurodegeneration. [Courtesy of Tarnawsky and Yoder, Nature, News & Views,2017.]

To find out if somatic mutations in EMPs could beget microglia that trigger neurodegeneration, first author Elvira Mass and colleagues induced a somatic mutation that causes histiocytoses into mice. They chose the V600E variant of the BRAF gene, a substitution that switches on ERK signaling. The researchers generated transgenic mice carrying an inducible copy of the mutated BRAF gene, which could only be switched on via tamoxifen-induced Cre recombination in EMPs. This also turned on yellow fluorescent protein so the researchers could identify the cells. At embryonic day 8.5, they injected pregnant mice with a teeny dose of the drug to ensure that only a fraction of the embryos EMPs would express the mutation. About 10 percent of tissue resident macrophages, including microglia, in the resulting offspring expressed V600E BRAF at one month ofage.

The mutant microglia took up their positions in the brain, but were different from their normal counterparts from the get-go. Those carrying the V600E BRAF expressed elevated markers of proliferation, ERK signaling, and inflammation. In one-month-old mice, these feisty microglia had yet to cause trouble, but by four months of age, the researchers noticed neurological symptoms in the mice, including loss of hind limb reflexes and shortened stride. At seven months, 90 percent of the animals were affected and by nine months 60 percent of the mice had full hind limb paralysis. These symptoms, similar to cerebellar ataxia, are common in people with cerebral histiocytoses. Feeding the mice a BRAF inhibitor starting at one month of age drastically delayed onset and slowedprogression.

Compared to wild-type mice (left), animals with induced BRAF mutations in their EMPs had an expansion of mutant microglia expressing YFP in their spinal cord (middle). Microglia also expressed the activation marker CD68 (top) and phosphorylated ERK (bottom). [Courtesy of Mass et al., Nature2017.]

The researchers next searched for pathological changes that could have triggered the disorder. In month-old mice, the researchers found signs of elevated microglial and astrocyte activation, but not neuronal death. Oddly, by immunohistochemistry using the 22C11 antibody, the researchers noticed deposits of amyloid precursor protein (APP) in the inflamed areas, a phenomenon that Geissmann attributed to release of the membrane protein from newly damaged axons. In six-month-old animals, large clusters of activated, phagocytic microglia carrying the BRAF mutation crowded in the thalamus, brain stem, cerebellum, and spinal cord. These same regions were rife with synaptic and neuronal loss, demyelination, and astrogliosis. The mutant microglia had a small proliferative advantage compared with their wild-type counterparts, but Geissmann attributed the bulk of the neuronal damage to the activation of the cells, rather than their expansion. Treatment with a BRAF inhibitor mitigated theseresponses.

Gene expression analysis of mutant microglia taken from paralyzed mice revealed the differential expression of around 8,000 genes, 80 percent of which were upregulated compared to microglia from control mice. These genes included a bevy of pro-inflammatory mediators, including cytokines, phagocytosis boosters, matrix proteins, and growthfactors.

For some reason, the thalamus, brain stem, cerebellum, and spinal cord were uniquely vulnerable to the presence of the V600E BRAF mutant cells. Tissue macrophages carrying the mutation also expanded in the liver, spleen, kidney, and lung, even more so than in the brain, but did not cause damage in those regions. Geissmann speculated that differences in the tissue microenvironment could play a role in this selective vulnerability. For example, normal liver macrophages are in a near constant state of activation, Geissmann said, so the organ is equipped to deal with them. Perhaps the posterior part of the brain is unaccustomed to constant microglial activation, he said. Indeed, chronic microglial activation occurs during AD as well, and appears to ultimately inflict damage, rather than helpfulresponses.

Finally, the researchers investigated whether patients with histiocytoses also had abnormal microglia. They analyzed postmortem brain tissue from three patients with Erdheim-Chester disease (ECD), and conducted gene expression analysis on brain biopsies from one person with Langerhans cell histiocytosis (LCH), and another with juvenile xanthogranuloma (JXG). All of these patients had neurodegenerative disease associated with their histiocytoses, which were all caused by BRAF V600E mutations. In the ECD samples, the researchers spotted abundant activated microglia gathered at sites of neuronal loss, astrogliosis, and demyelination. Compared with data from five control samples, gene expression analysis on the JXG and LCH samples revealed an upregulation of genes in the MAPK pathway, including multiple pro-inflammatorycytokines.

The findings support the idea that activated microglia wreak havoc in the brain and cause neurodegeneration in people withhistiocytoses.

For a somatic mutation to have an effect, affected cells must propagate sufficiently. EMPs proliferate during early development, making it a prime time for mutant clones to multiply, Geissmann said. Perhaps the number of mutant clones born during the EMP stage would suffice to harm neurons, he said. However, if microglia are also bestowed with a proliferative edge, this would likely exacerbate the damage, he added. Either way, Geissmann proposed that inhibitors of ERK signaling might thwart neurodegeneration when mutant microglia areinvolved.

In an accompanying editorial, Stefan Tarnawsky and Mervin Yoder at Indiana University in Indianapolis noted opportunities for better diagnosis in this scenario. When somatic mutations occur in EMPs during early development, macrophages in many regions of the body will likely carry the mutations, not just microglia in the brain. This suggests that it might be possible to collect macrophage samples from more easily accessible, non-CNS tissues to look for biomarkers when diagnosing microglia-related disease, theywrote.

What about somatic mutations that might arise later in life, when tissue resident macrophages or microglia are already nestled into their permanent residences? Though recent studies reported that microglia are relatively long-lived cells, they proliferate in response to threats (Aug 2017 news),perhaps setting the stage for expansion of mutant cells, Geissmann speculated. That said, beyond people with histiocytoses, the contribution of somatic mutations in microglia to neurodegenerative disease is unclear. De Strooper and others have reported that genetic mosaicism in neurons could cause neurodegeneration (Jul 2015 news). A major impediment to studying this phenomenon is that somatic mutations that arise in the brain go undetected in standard genomic sequencing.JessicaShugart

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Somatic SNAFUCan a Few Mutant Microglia Cause Neurodegenerative Disease? - Alzforum

Spinal Cord Stem Cells Comments Off on Somatic SNAFUCan a Few Mutant Microglia Cause Neurodegenerative Disease? – Alzforum | September 3rd, 2017

You might feel a bit down if you watch the news. Who wouldnt?

Angry people might be grabbing headlines and making you wonder about the future, but the antidote is all around you.

Talk to some of your neighbours. Chances are, no matter what they look like or where theyre originally from, youll find theyre actually pretty decent people just like you.

The little improvements we all try to make may not register much, but the accumulation of them all eventually does.

And if theres one tangible piece of proof that the world is changing for the better, its Lucas Lindner.

2016 was not a kind year for 22-year-old Lucas.

Last May he lost control of his pickup truck when a deer ran out on the road. The front passenger tire blew out. The truck rolled, throwing him out of the window.

When he woke up in the hospital, he was paralysed from the neck down. He was just heading to the grocery store on a Wisconsin Sunday morning.

It was an accident that could happen to anyone, to a friend or relative.

Normally, people like Lucas have no hope of restoring motor control of their bodies ever again.

In the United States, this awful story plays out 17,000 times every year. There are a quarter of a million people in the country with paralysis.

But Lucas story is working out a little bit differently.

Lucas was airlifted to Froedtert Hospital, a teaching hospital of the Medical College of Wisconsin.

There, Dr. Shekar N. Kurpad, professor of neurosurgery, applied 15 years of research into cell transplantation for spinal cord injury.

The procedure revolutionary and so were the cells Dr. Kurpad used.

The new procedure used cells that were developed over many years by researchers at a two companies leading the way in regenerative medicine.

Researchers at these companies have discovered how to grow stem cells and make them reliable for transplantation use.

On doctor, in fact, who Ive researched extensively, has been called the father of regenerative medicine.

Ive had the pleasure of meeting with him on a number of occasions.

Whenever I am in the San Francisco Bay Area, I try to visit him to learn whats going on in the field.

And from what Ive seen the therapeutic potential is hard to understate.

And were starting to see the results in people like Lucas Lindner.

Hes still wheelchair-bound we have a lot more to learn but he now has fine motor skills in his upper body. Thats extraordinary in cases like his.

Lucass miraculous improvement is due to newly designed pluripotent stem cells They are called pluripotent because they have the power to transform into any other cell type in the body.

And this Bay Area doctors company has accumulated the technology to make that happen.

Over the next few months, well get more clinical data from patients being treated with the full 20 million-cell dose and potentially more great news of restored motor function.

The recent headlines may have been about a few angry people rioting and hating each other, but the real important news is this

Recently, when the Cincinnati Reds played the Milwaukee Brewers, Lucas threw out the opening pitch.

Many U.S. presidents and other famous people have thrown pitches, but no pitch has been as historic as this one. And the advances I highlighted today are the reason why.

As this therapy matures and gets closer to market, I believe it will make a big impact on shares of companies in this space.

Which means the right-timed move in the upcoming months means a huge potential windfall of cash for you.

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A year ago he was paralysed from the neck down then this happened - The Daily Reckoning

Spinal Cord Stem Cells Comments Off on A year ago he was paralysed from the neck down then this happened – The Daily Reckoning | September 1st, 2017

Spinal injuries are oftenpermanent, but new research suggests such injuries may be healed, at least in part.Researchers were able to stimulate limb function in paralyzed mice by implanting human stem cells into theirspinal cords. We're not close to repeating the test in people, but the study shows it may be possible some day with further research.

The University of California-San Diego team grafted human neural stem cells (NSCs) into the spinal cord injuries of mice who were purposely injuredto impair the use of their front legs. The stem cells grew slowly, yet steadily, over the course of 18 months, retaining their original function despite being in a strange and challenging environment for an extended period of time. Whats more, eventually the rodents were able to use their front legs again.

"The bottom line is that clinical outcome measures for future trials need to be focused on long time points after grafting," said study researcher Mark Tuszynskiin a recent statement. Relying on shorter time frames might produce misleadingly negative results considering how long it takes neural stem cells to develop, he added.

For the study, the team used H9 human NSCs, which are a type of stem cell derived from human embryonic stem cells, as commonly used in scientific research, the statement reported. They then grafted these human stem cells into the spinal injuries of mice. The researchers observed the rodents recovery over the course of 18 months, noting that significant cellgrowth did occur soon after grafting, and continued up to a year after the initial implantation.

The most important observation was that these cells were able to continue to do what they were designed to doregrow neural cellsdespite the fact that they were transplanted into an entirely different species. This suggests the cells have resilience and similar experiments mayalso work in human subjects.

Before you get too excited about these results, the researchers emphasized that there were a number of caveats. First, humans and mice are entirely different species, and though the results observed in the rodents are promising, we don't know if they could be repeated in people.

Also, the researchers observed that some astrocytes, star-shaped neural cells associated with electrical impulse transmission, did migrate from the original implantation site to other areas of the rodents. These brain cells are classified as glial cells, which are noted to lead to devastating and difficult to treat cancers when they are dysregulated, Harvard University reported. However, there were no tumors or abnormal growths observed in the mice in the study and the researchers are trying to figure out way to make sure cancer doesn't develop.

Ultimately, the team believe that these results stand as a good foundation on which to buildfurther research.

Success, it would seem, will take time," concluded Tuszynski.

Source: Lu P, Ceto S, Wang Y, et al. Prolonged human neural stem cell maturation supports recovery in injured rodent CNS. The Journal of Clinical Investigation . 2017

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Stem Cell Graft Repairs Spinal Cord Injury, Helps Paralyzed Mice ... - Medical Daily

Spinal Cord Stem Cells Comments Off on Stem Cell Graft Repairs Spinal Cord Injury, Helps Paralyzed Mice … – Medical Daily | August 31st, 2017

A brain cell replacement therapy reduced Parkinsons disease symptoms in monkeys, Japanese researchers report in a study released Wednesday. The positive result boosts prospects to test the therapy in people.

The goal is to implant neurons derived from stem cells into the brains of Parkinsons patients, a project pursued by scientists in San Diego, New York, Britain and Sweden as well as in Japan. If all goes well, the neurons will function as replacements for those destroyed in the disease.

In addition, human testing of a related brain cell therapy from Carlsbads International Stem Cell Corp. is already under way in Australia.

While treatments exist for the movement disorders caused by Parkinsons, none of them actually halt progression. Replacing the brain cells destroyed in Parkinsons holds the promise of actually reversing the disease.

Moreover, success with Parkinsons could pave the way to treating many other neurodegenerative diseases, such as ALS (Lou Gehrigs disease) and perhaps Alzheimers, along with brain and spinal cord injuries. These afflictions cost hundreds of billions annually, and most importantly, produce immense suffering in patients and caregivers.

Years of extensive research are required before any such therapy can be tried in people. Testing in monkeys or other primates is often regarded as the last step before human treatment can be contemplated.

The study was published in the journal Nature. Its senior author was Jun Takahashi, a prominent stem cell researcher at Kyoto University in Kyoto, Japan. Go online to j.mp/parkips for the study.

There is precedent to suggest the therapy might work. Beginning decades ago, brain cells taken from human fetuses have been implanted into the brains of Parkinsons patients, with mixed results. Some patients experienced improved movement control. But others gained nothing, or experienced uncontrolled movements.

Scientists in the field say using stem cells should provide improved results. Stem cells can be made in greater quantity than the limited number of fetal brain cells available. In addition, the stem cells and neurons made from them can be analyzed for quality before implantation.

The study was praised by regenerative medicine researcher Tilo Kunath at the University of Edinburgh, in comments provided by the UK Science Media Centre.

This is extremely promising research demonstrating that a safe and highly effective cell therapy for Parkinsons can be produced in the lab, Kunath said.

Such a therapy has the potential to reverse the symptoms of Parkinsons in patients by restoring their dopamine-producing neurons. The next stage will be to test these therapies in a first-in-human clinical trial.

In the study, researchers produced neurons that secrete dopamine, a neurotransmitter deficient in Parkinsons disease. These neurons were made from human stem cells derived from both healthy people and those with Parkinsons.

The researchers then implanted the human neurons into 10 monkeys whose own dopamine-making neurons had been destroyed. The monkeys were given immunosuppressive drugs to prevent rejection of the human cells.

The human neurons integrated into the brains of the monkeys and functioned as dopamine-making neurons. The monkeys improved in movement ability, save for one monkey that became ill and was euthanized. Both cells from healthy and Parkinsons patients were effective.

A companion study in Nature Communications demonstrated a method of immune-matching the cells to reduce the immune response. Takahashi was also senior author of that study. Go online to j.mp/ipsimmune for the study.

Both studies used artificial embryonic stem cells, called induced pluripotent stem cells (IPS). These act-alike cells are not derived from embryos, but are genetically reprogrammed from adult cells, usually skin cells.

The IPS cells appear to act virtually identically to embryonic stem cells, but dont raise the ethical objections many have to using embryonic stem cells. These cells were invented in 2006 by a team led by Shinya Yamanaka, a co-author of the Nature Communications study.

Moreover, the cells can be made from the patients themselves, which is not expected to cause an immune reaction. This is the approach taken by the San Diego team, including scientists at The Scripps Research Institute.

Carlsbads International Stem Cell Corp. uses a different approach. It starts with unfertilized, or parthenogenetic, human egg cells. These are grown into immature neurons that are implanted. The cells are expected to grow not only into dopamine-making neurons, but other kind of brain cells that preserve the remaining neurons.

The Australian clinical trial has gathered evidence of safety, and continued testing is under way determine efficacy.

The Nature study dovetails with research by the San Diego group, Summit for Stem Cell, (www.summitforstemcell.org), including scientists at The Scripps Research Institute and doctors at Scripps Health.

The group proposes to treat Parkinsons patients with neurons grown from their own IPS cells. The scientists have received funding from the California Institute for Regenerative Medicine, the states stem cell agency.

The studies support the personalized approach that we are taking for a neuron replacement therapy for Parkinson's disease patients, said Jeanne Loring and Andres Bratt-Leal, stem cell scientists at The Scripps Research Institute.

Two points from the studies should be highlighted, Loring and Bratt-Leal said by email.

Parkinson's disease is a late-onset disorder, they said. That means that there was nothing wrong with the neurons that people with Parkinson's were born with. Few PD patients have a family history of the disease, which suggests that genetic mutations did not cause their disease.

So for the great majority of patients, transplantation of their own neurons is a promising approach to relieving symptoms, without having to take expensive and risky immunosuppressive drugs, they said.

The Summit for Stem Cell scientists are members of an international partnership of laboratories developing neuron replacement therapies for Parkinsons, called GForce PD.

Takahashi belongs to the partnership, as do scientists in the UK, Sweden and New York. These use both embryonic and IPS stem cells. The Summit for Stem Cell effort is the only one using patient-matched IPS cells, Loring and Bratt-Leal said.

Brain cells reprogrammed to make dopamine, with goal of Parkinsons therapy

Parkinson's stem cell therapy shows signs of safety

Parkinson's therapy funded by California's stem cell agency

Dopamine-making neurons can be chemically controlled in animal model of Parkinson's

Stem cell clinical trial for Parkinson's begins

Summit for Stem Cell

bradley.fikes@sduniontribune.com

(619) 293-1020

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Brain cell replacement for Parkinson's boosted by monkey study - The San Diego Union-Tribune

Spinal Cord Stem Cells Comments Off on Brain cell replacement for Parkinson’s boosted by monkey study – The San Diego Union-Tribune | August 31st, 2017

Researchers at the University of California San Diego and at the San Diego Veterans Administration Medical Center have shown that human neural stem cells (NSCs) grafted onto the spinal cord injuries of mice produced a functional recovery after one year. The team has shown that the NSCs continue to grow slowly and steadily even18 months after implantation.

The study is published in the Journal of Clinical Investigation and set out to answer how long it would take for the cells to mature inside the rodents. Mice and humans have a very different pace when it comes to cell biology.

"The NSCs retained an intrinsic human rate of maturation despite being placed in a traumatic rodent environment," lead author Professor Paul Lu said in a statement. "That's a finding of great importance in planning for human clinical trials."

The researchers were worried that the animal model would not reflect the how this approach might in the future work in humans. For example, pregnancies last 21 days in mice and 280 days in humans. And the weight of a toddlers brain is comparable with that of a 20-day-old mouse.

"Most NSC grafting studies have been short-term, measuring survival times in weeks to a few months," added co-author Professor Mark Tuszynski. "That's not enough time to fully measure the growth and maturation rate of human NSCs or what changes might occur farther out from the original grafting. These are important considerations, not just for the basic science of stem cell biology, but for the practical design of translational human trials using NSCs for spinal cord injuries."

The researchers report that the cells maintained their natural maturation pace even though they were in a foreign environment. Thats why it took several months for the lesions to begin healing. The scientists noted that improvement in the mice mobility only happened after more mature nerve cells formed. As the grafts aged, they displayed the expected pruning and cell redistribution activities that help the development of fewer but more mature cells.

"The bottom line is that clinical outcome measures for future trials need to be focused on long time points after grafting," said Tuszynski. "We need to take into account the prolonged developmental biology of neural stem cells. Success, it would seem, will take time."

The team noticed that none of the implanted NSCs migrated from the graft but some supportive astrocytes cells did, which could be a potential safety concern. No tumors or anomalous formation were created by these cells and modified grafting should fix the problem. A better understanding of this approach, so that the results can be carefully assessed, is required before we can even think to try it on humans.

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Human Stem Cells Repair Spinal Cord Injuries In Mice At Human Biological Rate - IFLScience

Spinal Cord Stem Cells Comments Off on Human Stem Cells Repair Spinal Cord Injuries In Mice At Human Biological Rate – IFLScience | August 30th, 2017

The FDAs commissioner Scott Gottlieb has pledged to crack down on unscrupulous actors attempting to treat patients with potentially dangerous or unproven stem cell therapies.

According to Gottlieb, these companies are able to promote, unproven, illegal and expensive treatments that offer little hope and could pose health risks to vulnerable patients, based on the clinical promise of regenerative medicine.

The crackdown comes after a number of shocking incidents in the US, including the case of three women who went blind following bogus treatment at a Florida clinic.

In a statement the FDA said it is stepping up enforcement to separate unscrupulous companies from those offering genuine treatments approved and backed with genuine medical evidence.

At the same time it will offer those with regenerative medicine products a less burdensome regulatory process although the regulator noted that in some cases individualised treatments fall outside the FDAs remit.

Gottlieb noted the FDA must tread a fine line, separating new medical products from those that are tailor-made by surgeons in such a way that they are not subject to its regulation.

The announcement comes after the US Marshals Service, on behalf of the FDA seized five vials of smallpox vaccine from California-based StemImmune.

The San Diego biotech was using the vaccinia virus vaccine to create an unapproved stem cell product, from cells derived from body fat.

This was being injected intravenously and directly into patients tumours potentially causing fatal health problems in unvaccinated people as the virus can cause inflammation and swelling of the heart.

The FDA also wrote to another operator, Floridas Stem Cell Clinic, raising issues about poor manufacturing standards. An inspection found the clinic was processing body fat into stem cells and administering directly into spinal cords of patients with illnesses such as Parkinsons disease, amyotrophic lateral sclerosis, and pulmonary fibrosis.

This autumn, Gottlieb said he will issue guidance documents outlining a new, efficient, process to evaluate safety and effectiveness of stem cell therapies.

The guidance will also implement provisions of the 21st Century Cures Act relating to regenerative medicine.

A compliance policy will give current product developers a very reasonable grace period to consult with the FDA so that they can meet required standards aside from outliers potentially harming public health.

Gottlieb said: We cant let a small number of unscrupulous actors poison the well for the good science that holds the promise of changing the contours of human illness and altering the trajectory of medicine and science.

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FDA cracks down on bogus cell therapy firms - pharmaphorum

Spinal Cord Stem Cells Comments Off on FDA cracks down on bogus cell therapy firms – pharmaphorum | August 30th, 2017

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:

Another Outbreak of Salmonella Traced to Pet Turtles

Thirty-seven people across 13 states have contracted salmonella infection from contact with pet turtles, the U.S. Centers for Disease Control and Prevention announced Tuesday.

The agency has for years warned Americans that reptiles such as turtles can be a potent source of the potentially dangerous bacterium, which attacks the gastrointestinal system.

In fact, the CDC notes that "since 1975, the FDA has banned selling and distributing turtles with shells less than 4 inches long as pets because they are often linked to salmonella infections, especially in young children."

In the the latest outbreak, illnesses began to appear on March 1 and diagnoses continued until Aug. 3, the agency said. No deaths have yet been reported, but 16 people have required hospitalization. The CDC says the outbreak may not yet be over.

The agency's advice? "Do not buy small turtles as pets or give them as gifts. All turtles, regardless of size, can carry Salmonella bacteria even if they look healthy and clean."

Federal Prisons Must Now Make Free Tampons, Pads Available

New policy from the Federal Bureau of Prisons (FBP) now requires that all facilities make feminine hygiene products, such as tampons and pads, available for free to prisoners who need them.

In an email memo issued earlier in August, FBP spokesman Justin Long said that "wardens have the responsibility to ensure female hygiene products such as tampons or pads are made available for free in sufficient frequency and number. Prior to the (memo), the type of products provided was not consistent, and varied by institution."

Andrea James is a former lawyer and founder of the National Council for Incarcerated and Formerly Incarcerated Women and Girls. In 2010 and 2011, she served 18 months in a federal prison.

Speaking with CNN, James recalled tough choices made by prisoners involving feminine hygiene products, which the prisoners themselves had to pay for.

"We were paid 12 cents an hour [for in-prison work]," she said, and that wage could be spent on other things, such as phone calls. "That's the choice. Do I buy the tampons or do I call my children?"

According to CNN, the new policy arrives a month after Democratic Senators Cory Booker, Elizabeth Warren, Dick Durbin and Kamala Harris introduced the Dignity for Incarcerated Women Act into Congress. Among other issues, the Act requires that women in prisons have access to multiple sizes of free tampons, pads and liners. Long said the new announcement had nothing to do with the proposed law, however.

In a statement, Harris said she applauded the memorandum, adding, "too many women reside in prison and jail facilities that don't support basic hygiene or reproductive health, and that's just not right."

FDA: Serious Problems at Florida Stem Cell Clinic

A Florida stem cell clinic has been cited by the U.S. Food and Drug Administration for what the agency describes as serious problems that could pose health risks to patients.

The agency said Monday that it has cited US Stem Cell Clinic, of Sunrise, for marketing stem cell products without FDA approval and for "significant deviations from current good manufacturing practice requirements," including some that could affect the "sterility of their products, putting patients at risk."

"Stem cell clinics that mislead vulnerable patients into believing they are being given safe, effective treatments that are in full compliance with the law are dangerously exploiting consumers and putting their health at risk," FDA Commissioner Dr. Scott Gottlieb said in a news release.

The FDA said it recently inspected US Stem Cell Clinic and found that it was processing fat tissue into stem cells derived from body fat and administering the product both intravenously or directly into the spinal cord of patients to treat a variety of serious health problems. Those problems included Parkinson's disease, amyotrophic lateral sclerosis (Lou Gehrig's disease), chronic obstructive pulmonary disease (COPD) and heart disease, among others.

The FDA said it hasn't approved any biological products made by US Stem Cell Clinic for any use.

During an inspection, FDA investigators also found evidence of "significant deviations from current good manufacturing practices" in the production of at least 256 lots of stem cell products. Those deviations included "failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of products purporting to be sterile, which puts patients at risk for infections."

US Stem Cell Clinic also tried to hamper the FDA's investigation during a recent inspection "by refusing to allow entry except by appointment and by denying FDA investigators access to employees," the agency said.

Interfering with an FDA inspection is a violation of federal law, the agency said.

The FDA said it wants to hear from US Stem Cell Clinic within 15 working days, detailing how the problems cited in the agency warning letter will be fixed. If the problems aren't corrected, the company faces such enforcement actions as seizure, injunction or prosecutions, the agency said.

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Health Highlights: Aug. 29, 2017 - Bloomington Pantagraph

Spinal Cord Stem Cells Comments Off on Health Highlights: Aug. 29, 2017 – Bloomington Pantagraph | August 30th, 2017

The U.S. Food and Drug Administration announced a crackdown on stem-cell clinics marketing and selling unapproved and potentially harmful therapies for cancer and other diseases.

The agency took action against two large clinics in Florida and California, which have started selling treatments that the agency says use stem cells but have not been approved as safe and effective by the FDA.

"A small number unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt, assurances to patients based on unproven and, in some cases, dangerously dubious products," FDA Commissioner Scott Gottlieb, M.D., said in a statement.

The FDA issued a warning letterto US Stem Cell Clinic of Sunrise, Florida, after an inspection in which the agency found that the clinic was processing body fat into stem cells and administering the product both intravenously or directly into the spinal cord of patients with Parkinson's disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), heart disease and pulmonary fibrosis.

"The FDA has not reviewed or approved any biological products manufactured by US Stem Cell Clinic for any use," the agency said in a statement.

During the inspection, investigators also reported the clinic deviated from guidelines put in place to prevent microbiological contamination, which puts patients at risk for infections, the agency said.

Also this week, the FDA seized five vials of a smallpox vaccinefrom StemImmune Inc. in San Diego, California, which the agency said was used to create an unapproved treatment of stem cells and excess amounts of the vaccine, which was then administered to cancer patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California.

The FDA says this treatment put patients at risk for potential harms including inflammation and swelling of the heart and surrounding tissues.

The agency said it will investigate how StemImmune Inc. obtained the vials of the vaccine, which each contained 100 doses. The vaccine is not commercially available and is reserved only for people considered at high risk for smallpox, such as some members of the military. One vial was partially used, while four of the vials were still intact, the FDA reports.

"I've directed the agency to vigorously investigate these kinds of unscrupulous clinics using the full range of our tools, be it regulatory enforcement or criminal investigations. Our actions today should also be a warning to others who may be doing similar harm, we will take action to ensure Americans are not put at unnecessary risk," Gottlieb said.

In response, Dr. Mark Berman, co-founder of the California Stem Cell Treatment Centers, told the Los Angeles Times that the comments from the FDA are "disparaging and misrepresentative," and said they showed "a lack of understanding" of surgical procedures in which patients' own stem cells are used to promote regeneration.

Berman, who is also director of stem cell implantation at StemImmune, called the clinic's products "cutting edge cancer therapy" for Stage 4 cancer patients, the Times reports.

US Stem Cell Clinicposted a response to its website, saying, "The safety and health of our patients are our number one priority and the strict standards that we have in place follow the laws of the Food and Drug Administration."

"The FDA has stated that they will have specific stem cell guidelines by the 21st Century Cures Act deadline of December 13, 2017 and we intend to follow those standards as well," the statement continues. "We have helped thousands of patients harness their own healing potential. It would be a mistake to limit these therapies from patients who need them when we are adhering to top industry standards."

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FDA cracks down on clinics selling unapproved stem cell therapies - CBS News

Spinal Cord Stem Cells Comments Off on FDA cracks down on clinics selling unapproved stem cell therapies – CBS News | August 29th, 2017

A human stem cell replicating itself.

Hal X. Nguyen and Aileen J. Anderson

But when it comes to spinal cord injuries, the healing process goes awry.

Immune cells rush in and cause a scar that blocks the ability of neurons to regrow and reconnect. However, recent studies have shown that the immune system can also aid regeneration.

The immune system has both positive and a negative impact what it does is really context specific, says Jan Kaslin, who studies neural regeneration in zebrafish at the Australian Regenerative Institute of Medicine in Melbourne, Australia.

Stem cells provide a great hope for damaged spinal cords and brain injury but it has not been clear on how the immune system may affect the regrowth.

Now a new study has taken a look at how stem cells and the immune system interact in the repair of the spinal cord. Led by Aileen Anderson from the University of California, Riverside and published in the Journal of Neuroscience, the study suggests that whether or not the immune system hinders or helps transplanted stem cells to regrow lost tissue may be influenced by the presence of certain kinds of immune cells.

The study used stem cells derived from human foetal brain tissue and transplanted them into mice with a wound in their spinal cord. They then blocked the invasion of a specific population of immune cells called neutrophils and observed how well the wound was repaired by transplanted the stem cells.

In contrast to earlier research, Andersons team found with that with neutrophils out of the way the wound healed more easily, requiring few stem cells.

This is the first data to show that the immune environment can be altered to allow stem cell populations to perform better in terms of restoring function, according to Anderson.

Can other immune cells be manipulated to increase the effectiveness of stem cell transplantation in spinal cord regeneration?

These findings are an important of piece of the puzzle, says Kaslin, that may significantly improve future stem cell transplantation approaches.

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Immune cells may prevent stem cell growth in spinal cord repair - Cosmos

Spinal Cord Stem Cells Comments Off on Immune cells may prevent stem cell growth in spinal cord repair – Cosmos | August 28th, 2017

Jerika Bolen, the 14-year-old who made headlines when she decided to stop treatment for Type 2 Spinal Muscular Atrophy, has died.

Jerika Bolen and her mother, Jen, share a moment on the way to a July 2016 prom in Appleton, Wis. Jerika died in September 2016, after she decided to end treatment for an incurable genetic disease.(Photo: Danny Damiani, The (Appleton, Wis.) Post-Crescent)

APPLETON, Wis. Nearly one year after a Wisconsin teen with an incurable genetic disease announced her intention to go without a life-sustaining ventilator, experts say her case has had surprisingly minimal impact on the right-to-die debate.

"I fully expected it to continue in the dialogue," said Paul J. Ford, director of the NeuroEthics Program at Cleveland Clinic, about Jerika Bolen's story.

Jerika, of Appleton, Wis., died last September after a lifelong battle with spinal muscular atrophy type 2, which destroys nerves cells in the brain stem and spinal cord that control voluntary muscle activity. Her death last year came after a final summer that included a prom in her honor in July.

When I decided, I felt extremely happy and sad at the same time, Jerika told USA TODAY NETWORK-Wisconsin in July 2016. There were a lot of tears, but then I realized Im going to be in a better place, and Im not going to be in this terrible pain."

More: Following 'Last Dance' prom, Wisconsin teen Jerika Bolen dies

Jerika's decision drew national attention, including an overwhelming amount of support from well-wishers worldwide. But her story also drew the ire of disability rights groups who attempted to intervene in Jerika's decision to stop treatment.

For Jerika's case, it really pushes the boundaries between the right to refuse treatment and assisted suicide.

"It was an exceedingly complicated case," said Arthur Caplan, head of the division of bioethics at New York Universitys School of Medicine. "(Jerika) was 14, so not quite old enough to be legally able to make her decisions, but old enough that many (medical experts) would say she was old enough to help determine her care."

Jerika was mostly immobile and in chronic pain from spinal muscular atrophy. She ranked her pain as a seven on a scale of one to 10 on her best days.

Medications had damaged her body. She had more than 30 visits to operating rooms. She had her spine fused in 2013 and the heads of her femurs removed in 2015.

The day of Jerika's death, Jen Bolen, who declined to be interviewed for this story, told USA TODAY NETWORK-Wisconsin that "no one in their right mind would let someone suffer like she was.

"Suffering is a pretty strong, compelling reason to back away," Caplan said.

Not Dead Yet, a national disability rights group, was one of five disability rights groups that asked authorities to conduct an investigation into Jerika's care.

Diane Coleman, Not Dead Yet's president and CEO, said the groups questioned Jerika's decision to die, as well as the public's response.

More: Wisconsin teen's battle to stop treatment isnt unique

More: Is Wisconsin teen's decision to die a turning point?

"We were trying to be gentle and respectful, but also to say that Jerika had a lot to live for, even if she couldn't yet see that herself," Coleman said.

(Jerika) was 14, so not quite old enough to be legally able to make her decisions, but old enough that many (medical experts) would say she was old enough to help determine her care.

A letter Not Dead Yet and other disability rights groups wrote in early August 2016 raised questions about Jerika's care and said the teenager was "clearly suicidal." Disability Rights Wisconsin also wrote a letter to Outagamie County, Wis., child protection authorities.

"For Jerika's case, it really pushes the boundaries between the right to refuse treatment and assisted suicide," Coleman said. "If she had continued using her (ventilator) ... things would be different, and she didn't get to get there.

"Almost all of the coverage supported her death. That's what's wrong."

Ford said it's difficult from the outside to understand a person's life and level of suffering.

"(Jerika) went through a lot," Caplan said. "She knows more about that than many people weighing in on what should happen."

Caplan said Jerika's story didn't take on the dimension of Terry Schiavo, a Florida woman who remained in a "persistent" vegetative state for 15 years, or Brittany Maynard, a 29-year-old with brain cancer who relocated to Oregon so she could legally kill herself with medication.

"(Jerika) was saying, 'I've been through so much. I don't want to do this anymore,' " Caplan said. "Which is an important question, but it isn't quite analogous to what happens either when someone requests help in dying or says, 'I don't want to be maintained because I'm so old and so frail that there's no point.' She was in a different situation."

More: Q&A: What you should know about right to die

More: Child neglect claimed in teen's plan to end her own life

Caplan said Americans are "completely and utterly confused" about right-to-die issues, including how to deal with mental impairment in dying, whether to honor a child's request and even what constitutes death.

"Where views diverge is saying how much suffering is too much to ask someone to bear, and whose responsibility is it to partake in ending a life if it's more suffering than anyone ought to bear," Ford, the Cleveland Clinic ethicist, said.

One of those issues is physician-assisted suicide. Public opinion about the practice remains divided: a 2013 Pew Research Center survey found that 47% of Americans approve of laws to allow the practice for the terminally ill, while 49% disapprove.

Five states California, Colorado, Oregon, Vermont and Washington and Washington, D.C., have legalized the practice, and Montana recognized it following a state Supreme Court ruling.

Ford said there was "a great energy among states" to continue the legislation for terminally ill adults a year ago.

More: Teen's plan to die has disability groups seeking intervention

More: More than a thousand people turn out for prom of Wisconsin teen choosing to die

"Those have sort of taken a backseat, recently," he said.

Earlier this year, Wisconsin State Rep. Sondy Pope introduced legislation, modeled closely after other physician-assisted suicide laws, that would allow terminally ill Wisconsin adults to receive medication to end their lives.

Pope, who conceded that the legislation has no immediate chance of becoming law, said she would support legislation to allow a minor who isn't terminal to die with "very, very thoughtful safeguards that include input from loved ones."

"That's way down the road in a case-by-case individual basis ... It doesn't seem right, morally, to say, 'I'm sorry. You're not 18. You have to suffer.' "

Follow Ethan Safran on Twitter:@EthanSafran

More: Girl, 14, with incurable disease makes heartbreaking decision to die

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Year after Jerika Bolen's death, debate continues on right-to-die issues - USA TODAY

Spinal Cord Stem Cells Comments Off on Year after Jerika Bolen’s death, debate continues on right-to-die issues – USA TODAY | August 28th, 2017

Jack Massey is ready to go back to school.

Only this time, the University of Florida senior will head back to campus with his mom and a new outlook on life.

Massey suffered a spinal cord injury in a pool accident in March and is paralyzed from the chest down. After months of rehab, he's eager to get back into a familiar routine.

"It's definitely boring," the 21-year-old said at his parents' home in Niceville. "There's not a lot to do. I want to go back to school. I still have my brain. I still have everything I need to be successful."

After the accident March 17, Massey was treated at the University of Florida Shands Hospital and then was transferred to Shepherd Center, a spinal cord and brain injury rehab center in Atlanta. At Shepherd Center he met with a peer mentor, counselors and physical therapists to help him find a new normal.

Jack has remained positive throughout the past six months.

"Jack has been a fighter through all of this," said his mother, Julie. "I think he's done well. I only saw him break down once."

Before the accident, Jack was a well-rounded athlete who playing baseball and basketball and ran. He was a star on the track and field team at Niceville High School, with his 4 X 800 relay winning state his senior year.

He says the biggest challenge now is not being able to do the same things he could before.

"I can't get up and go," he said. "It didn't really start to set in until after I got out of rehab."

Jack has had to find enjoyment in other things, like reading or playing with the dogs. His friends have learned to transfer him from his wheelchair to a car so they can take him to the movies or out to eat. When they recently took a trip to the beach, Julie said five of Jack's friends carried him out to the sand a lesson on how hard it is to navigate the world in a wheelchair.

Jack said he believes technology one day will advance enough that he won't be paralyzed forever. He also volunteered to do stem cell surgery to allow doctors to study the effects of stem cells on his spine for the next 15 years. Instead of wallowing in self-pity, he's moving forward. But he'll need help.

"I'm appreciating everything in the now," he said.

Doctors have said Jack has adapted faster than expected, but there are still some everyday essential tasks that are out of his reach. He cannot write or cook. He can shower himself but can't dry himself or transfer himself in and out of his wheelchair. The Massey family hopes to secure a personal care attendant for Jack at school, but until then Julie will be in Gainesville to help him transition. An occupational therapy student from the university will also help Jack on a temporary basis.

Finding proper care for her son has proven to be a learning experience for Julie and her husband, Lance.

"I don't know how people do it," she said. "We have good health care, but then there's hidden costs. There's travel expenses. ... It's kind of humbling. Nobody should have to go to GoFundMe for medical help."

Jack wants to spend his final year as an undergrad as independent as possible. After months of helping him recover, Julie said it will be hard to let her son go. Jack is the oldest of three; his brother Lance is 19 and a student at UF and his sister Alina is 14 and attends Ruckel Middle School.

"It's like letting him go off to kindergarten again," she said.

As for life after college, Jack said he doesn't feel limited in career choices. One of his professors in the geology department encouraged him by saying that there were plenty of opportunities he could pursue in that field. Jack said he may also consider law school. One thing he's learned through this life-altering experience is that there are no limits to what he can achieve.

"I haven't done that much deep thinking. I just go with the flow," he said. "But I learned I have more perseverance. I'm more mentally tough than I thought I was. I'm appreciative for life in general. That's one of the big things."

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Paralyzed after pool accident, student heads back to college | News ... - News & Observer

Spinal Cord Stem Cells Comments Off on Paralyzed after pool accident, student heads back to college | News … – News & Observer | August 27th, 2017

NICEVILLE, Fla. (AP) Jack Massey is ready to go back to school.

Only this time, the University of Florida senior will head back to campus with his mom and a new outlook on life.

Massey suffered a spinal cord injury in a pool accident in March and is paralyzed from the chest down. After months of rehab, he's eager to get back into a familiar routine.

"It's definitely boring," the 21-year-old said at his parents' home in Niceville. "There's not a lot to do. I want to go back to school. I still have my brain. I still have everything I need to be successful."

After the accident March 17, Massey was treated at the University of Florida Shands Hospital and then was transferred to Shepherd Center, a spinal cord and brain injury rehab center in Atlanta. At Shepherd Center he met with a peer mentor, counselors and physical therapists to help him find a new normal.

Jack has remained positive throughout the past six months.

"Jack has been a fighter through all of this," said his mother, Julie. "I think he's done well. I only saw him break down once."

Before the accident, Jack was a well-rounded athlete who playing baseball and basketball and ran. He was a star on the track and field team at Niceville High School, with his 4 X 800 relay winning state his senior year.

He says the biggest challenge now is not being able to do the same things he could before.

"I can't get up and go," he said. "It didn't really start to set in until after I got out of rehab."

Jack has had to find enjoyment in other things, like reading or playing with the dogs. His friends have learned to transfer him from his wheelchair to a car so they can take him to the movies or out to eat. When they recently took a trip to the beach, Julie said five of Jack's friends carried him out to the sand a lesson on how hard it is to navigate the world in a wheelchair.

Jack said he believes technology one day will advance enough that he won't be paralyzed forever. He also volunteered to do stem cell surgery to allow doctors to study the effects of stem cells on his spine for the next 15 years. Instead of wallowing in self-pity, he's moving forward. But he'll need help.

"I'm appreciating everything in the now," he said.

Doctors have said Jack has adapted faster than expected, but there are still some everyday essential tasks that are out of his reach. He cannot write or cook. He can shower himself but can't dry himself or transfer himself in and out of his wheelchair. The Massey family hopes to secure a personal care attendant for Jack at school, but until then Julie will be in Gainesville to help him transition. An occupational therapy student from the university will also help Jack on a temporary basis.

Finding proper care for her son has proven to be a learning experience for Julie and her husband, Lance.

"I don't know how people do it," she said. "We have good health care, but then there's hidden costs. There's travel expenses. ... It's kind of humbling. Nobody should have to go to GoFundMe for medical help."

Jack wants to spend his final year as an undergrad as independent as possible. After months of helping him recover, Julie said it will be hard to let her son go. Jack is the oldest of three; his brother Lance is 19 and a student at UF and his sister Alina is 14 and attends Ruckel Middle School.

"It's like letting him go off to kindergarten again," she said.

As for life after college, Jack said he doesn't feel limited in career choices. One of his professors in the geology department encouraged him by saying that there were plenty of opportunities he could pursue in that field. Jack said he may also consider law school. One thing he's learned through this life-altering experience is that there are no limits to what he can achieve.

"I haven't done that much deep thinking. I just go with the flow," he said. "But I learned I have more perseverance. I'm more mentally tough than I thought I was. I'm appreciative for life in general. That's one of the big things."

___

Information from: Daytona Beach (Fla.) News-Journal, http://www.news-journalonline.com

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Paralyzed after pool accident, student heads back to college - San Francisco Chronicle

Spinal Cord Stem Cells Comments Off on Paralyzed after pool accident, student heads back to college – San Francisco Chronicle | August 27th, 2017

Here are eight things for spinal surgeons to know for Aug. 24, 2017.

Medtronic Q1 revenue jumps 3% to $7.4BMedtronic reported a slight revenue increase in the first quarter of the 2018 fiscal year. First quarter revenue hit $7.39 billion, up 3 percent over the same period last year. U.S. revenue increased 1 percent to $4 billion, representing 55 percent of the company's overall revenue. Non-U.S. revenue hit $2.3 billion, up 4 percent over the same period last year, and emerging market revenue was $1 billion, up 11 percent over last year.

DuPage Medical Group to grow with $1.45B investmentWith a $1.45 billion investment from Ares Management, DuPage Medical Group is looking to expand its services and the number of physicians, the Chicago Tribune reports. Currently, the group has a team of 800 providers and plans to grow to between 1,200 and 1,500. DuPage Medical Group is also considering expanding further beyond Illinois. Along with adding more physicians, DuPage Medical Group plans to add services such as imaging, immediate care, physical therapy and oncology.

Spineology receives $10M fundingDuring Spineology's latest round of funding, the company secured $10 million. Spineology began taking $25,000 investments for the recently closed round a year ago. The company has not announced its plans for the funding.

Former Yale Spine Co-Chief Dr. James Yue joins Connecticut Orthopaedic SpecialistsJames Yue, MD, joined Connecticut Orthopaedic Specialists. He previously served as the co-chief of orthopedic spine surgery at New Haven, Conn.-based Yale School of Medicine and director of the ACGME Yale Spine Fellowship. As a member of Connecticut Orthopaedic Specialists, Dr. Yue will see patients in Shelton, Hamden and Essex, Conn.

Merger: Advanced Pain Medicine now under Commonwealth Pain & Spine umbrella Lexington, Ky.-based Advanced Pain Medicine merged with Louisville, Ky.-based Commonwealth Pain & Spine. Commonwealth Pain & Spine consists of more than seven locations and 30 providers. The merger came to fruition due to Advanced Pain Medicine's Saroj Dubal, MD, deciding to retire.

Washington University School of Medicine new spinal cord injury clinical trial siteThe St. Louis-based Washington University School of Medicine is a new clinical study site for Asterias Biotherapeuturics SCiStar clinical trial of AST-OPC1 stem cells in patients with severe cervical spinal cord injuries. W. Zachary Ray, MD, a neurological and orthopedic surgery associate professor at Washington School of Medicine, will lead the site's investigation.

EIT acquires 22 patents from spine surgeon Dr. Morgan LorioEmerging Implant Technologies acquired a portfolio of patents from Morgan P. Lorio, MD, of Nashville, Tenn.-based Hughston Clinic Orthopaedics. The portfolio includes 22 issued and pending patents for 3-D printed expandable spinal fusion cages. EIT plans to leverage this technology to enhance its cellular titanium cages.

Global minimally invasive spine surgery market to grow at 7.6% CAGR through 2021The global minimally invasive spine surgery market is anticipated to grow at a 7.57 percent compound annual growth rate between 2017 and 2021, according to an Absolute Reports analysis. DePuy Synthes, Medtronic, NuVasive, Stryker and Zimmer Biomet lead the global MIS spine market. A key market trend is an increase in MI sacroiliac joint fusion.

More articles on spine:Cord lengthening: Part of comprehensive AIS treatment6 key findings on spinal epidural hematomaThe causes and treatments for spinal hemangiomas

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8 things for spine surgeons to know for Thursday Aug. 24, 2017 - Becker's Orthopedic & Spine

Spinal Cord Stem Cells Comments Off on 8 things for spine surgeons to know for Thursday Aug. 24, 2017 – Becker’s Orthopedic & Spine | August 25th, 2017

Hope is surely on the way for children with special needs as Alok Sharma, a world renowned neurosurgeon, Neuroscientist and professor, a director of NeuroGen Brain and Spine Institute India visited Nigeria recently to shed light on the efficacy of stem cells in treating children with special needs.With over 5000 patients treated from 50 countries, 68 scientific papers and 14 published books, and an overall 91% success rate, Alok was determined to enlighten participants who attended the one day seminar on stem cell awareness and its importance.According to Asok, We are the pioneers of introduction to Stem Cell Therapy for neurological disorders. We make use of holistic, comprehensive approach to treat our patients with a combination of stem cell therapy and neuro-rehabilitation. We use adult stem cells derived from the patients own bone marrow, as they are the safest and most feasible type of cells. Since every patient is different, our treatment protocol is customised according to the patients requirements.We now have a treatment that is very effective and a large number of people can benefit from this. The old thinking was that when the central nervous system is damaged then it is beyond repairs but the new thinking is that some degree of repair is possible. Stem cells have three capabilities. They repair, regenerate or replaced. It took us between seven to eight years to prove that stem cells can convert to nerve cells and when we became very sure, we went on to use on humans and the results have been outstanding He said.Asked who can be treated with the stem cell procedure and Asok says for paediatric, we treat children with autism, cerebral palsy, intellectual disability and muscular dystrophy. For adults, we treat spinal cord injury, stroke, traumatic brain injury/head injury, motor neuro disease/amyotrophic lateral scierosis and other neurological disorders.Asok explains that there are many types of stem cells used, but broadly they can be classified into 3 types:-Embryonic stem cells: Embryonic stem cells, as their name suggests, are derived from 3-4 day embryos. These are obtained from spare embryos from IVF clinics with the consent of the donor. During this early developmental period, the cells that will ultimately give rise to the developing fetus can be encouraged to develop into tissues of different origins (totipotency) contributing greatly to stem cell therapy. However, there are many ethical and medical issues regarding its use. These are therefore, not being used presently.Umbilical cord stem cells: These cells are derived from the umbilical cord which connects the baby and the mother at birth. Stem cells derived from the umbilical cord are stored by various cord blood banking companies. These stem cells do not have any major ethical issues surrounding their usage, but availability can be a problem.Adult stem cells: They can be derived from the same patient, from either the hip bone or the adipose/fat tissue. Currently, they are the most popularly used stem cells. The benefits that adult stem cells offer are:1, They are available in abundance and can be isolated easily.2, They are isolated from patients, which overcomes the problem of immunological rejection.3, Adult stem cells have the potential to replenish many specialized cells from just a few unspecialized ones.4, They do not have any ethical issues as they do not involve destruction of embryos.5, The risk of tumor formation is greatly reduced as compared to the use of embryonic stem cells.There are fears about stem cell therapy but Asok cleared the air when he said this isnt the truth as the one feared is the embryonic stem cells (ESCs) which are stem cells derived from the undifferentiated inner mass cells of a human embryo. ESCs are just one of the types of stem cells but we do not make use of that in our hospital as explained earlier, we use Adult Stem Cells. We do not use the embryotic stem cells because they have the tendency to become tumours in the body. He explained.On how the procedure works, he says a thin needle is inserted into the hip bone to pull the marrow out. The procedure takes between 15 to 30 minutes. The patient is then sent back to the room for about 3 to 4 hours to rest for the next procedureon same day, within the 2 to 4 hours, the stem cells are separated and purified in their stem cell laboratory by using density gradient centrifugation. Once the stem cells have been purified, the patient is taken back to the operation theatre and the stem cells are injected into the spinal space. In some patients, for instance, patients with muscular dystrophy, the stem cells are diluted and injected into the muscles using a very thin needle.One of the participants at the seminar, Marvis Isokpehi, whose child is autistic, had this to say I am glad I came for this seminar. Initially, we were told anything that has to do with brain damage cannot be cured or improved only managed but we see that God helping the scientist, things are getting better. My child was diagnosed by 2. She walked at 17 months, sat at 8 months and she only babbled. She could use her hands and able to put things in her mouth herself but later, the growth began to drop and along the line, I took up the challenge and went back to school to learn about taking care of her and also to help others. I went to Federal College of Education (special) Oyo and specialised in Education for the intellectually disabled. Said Marvis.For Akhere Akran, the Manager of Agatha Obiageli Aghedo Memorial Foundation and participant, one of the arms of our foundation aimed at helping to lessen the burden of the less privileged in the community is the St Agatha Children Centre, where we advocate for children with special needs. I am glad I will be going back to let the parents of these children know there is hope and I am trusting God for funds because that is truly the core of everything. I appeal to the government to fund this and encourage private organisations to help reduce the cost of this treatment to the barest minimum. Its high time we stop stigmatisation or thinking its a result of the mothers past life of the fathers mistakes. It is a medical situation that needs medical attention. Akran expressed.Andelene Thysse is a director at Stem Cell Africa and she helped facilitate the seminar and for her, it is high time Nigeria gets involved We are currently looking at establishing a stem centre at Mozambique. I would have loved that we establish in Nigeria because Nigeria is closer to everything but since we arent getting the audience required, we are going to other African countries interested. Going to NeuroGen Institute for treatment per patient costs about $11,000 imagine if Nigeria has the facility, the price can slash down to $6,000 or even below Andelene stated.Shedding more light on costing, Asok says If we are to set up such a facility in an existing hospital, the cost of setting it up is $US500, 000 and I am assuming all facilities are functioning already. If we have to set up as a whole which includes getting land and building, it will be more expensive. This may sound expensive but it is worth it because it will save you the stress for the future. More important than the money is the permission from the government of the country. The government has to give us the permission because it is what is happening in other African countries. We have had good response and cooperation from government in Kenya, South Africa and Zimbabwe. We have quite a number of Nigerians who come to us in India for this treatment. We treat 50 patients from around the world per week about 5-10 are from Africa and Nigeria is among this percentage.

Kemi Ajumobi

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Stem cell therapy: proffering hope for special needs patients ... - BusinessDay (satire) (press release) (registration) (blog)

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Acupuncture

Acupuncture is a technique in which practitioners stimulate specific points on the body - most often by inserting thin needles through the skin. It is one of the most effective practices used in traditional Chinese medicine. Acupuncture stimulates nerve fibers to transmit signals to the spinal cord and brain, activating the bodys central nervous system. The spinal cord and brain then release hormones responsible for making us feel less pain while improving overall health. Acupuncture may also: increase blood circulation and body temperature, affect white blood cell activity (responsible for our immune function), reduce cholesterol and triglyceride levels, and regulate blood sugar levels.

Aquatherapy

Aquatic Physical Therapy is the practice of physical therapy in a specifically designed water pool with a therapist. The unique properties of the aquatic environment enhance interventions for patients with neurological or musculoskeletal conditions. Aquatic therapy includes a wide range of techniques allowing patients to improve their balance, muscle strength and body mechanics. Aquatic therapy works to enhance the rehabilitation process and support effectiveness of stem cell treatment.

Epidural Stimulation

Hyperbaric Oxygen Therapy

Hyperbaric Oxygen Therapy (HBOT) is the medical use of oxygen at a level higher than atmospheric pressure. The equipment required consists of pressure chamber, which may be of rigid or flexible construction, and a means of delivering 100% oxygen into the respiratory system. Published research shows that HBOT increases the lifespan of stem cells after injection and provides an oxygen-rich atmosphere for the body to function at optimum levels.

Nerve Growth Factor (NGF)

Nerve growth factor (NGF) is a member of the neurotrophic factor (neurotrophin, NTFS) family, which can prevent the death of nerve cells and has many features of typical neurotransmitter molecules. NGF plays an important role in the development and growth of nerve cells. NGF is synthesized and secreted by tissues (corneal epithelial, endothelial, and corneal stromal cells), and it can be up-taken by sympathetic or sensory nerve endings and then transported to be stored in neuronal cell bodies where it can promote the growth and differentiation of nerve cells.NGF can exert neurotrophic effects on injured nerves and promote neurogenesis (the process of generating neurons from stem cells) that is closely related to the development and functional maintenance and repair of the central nervous system. It is also capable of promoting the regeneration of injured neurons in the peripheral nervous system, improving the pathology of neurons and protecting the nerves against hypoxia (lack of oxygen)/ischemia (lack of blood supply).

Nutrition Therapy

Occupational Therapy

Occupational therapy interventions focus on adapting the environment, modifying the task and teaching the skill, in order to increase participation in and performance of daily activities, particularly those that are meaningful to the patient with physical, mental, or cognitive disorders. Our Occupational Therapists also focus much of their work on identifying and eliminating environmental barriers to independence and participation in daily activities, similar to everyday life.

Physiotherapy

Physical therapy or physiotherapy (often abbreviated to PT) is a physical medicine and rehabilitation specialty that, by using mechanical force and movements, remediates impairments and promotes mobility, function, and quality of life through examination, diagnosis, prognosis, and physical intervention. We combine our PT with stem cells for maximum physical rehabilitation improvements.

Transcranial Magnetic Stimulation

Research has shown that TMS can effectively treat symptoms of depression, anxiety, neurological pain, stroke, spinal cord injuries, autism and more. This procedure is very simple and noninvasive. During the procedure, a magnetic field generator or coil is placed near the head of the person receiving the treatment. The coil produces small electrical currents in the region of the brain just under the coil via electromagnetic induction. This electrical field causes a change in the transmembrane current of the neuron which leads to depolarization or hyperpolarization of the neuron and the firing of an action potential.

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Stem Cell Treatment for Spinal Cord Injury - Beike ...

Spinal Cord Stem Cells Comments Off on Stem Cell Treatment for Spinal Cord Injury – Beike … | August 25th, 2017

Jack Massey is ready to go back to school.

Only this time, the University of Florida senior will head back to campus with his mom and a new outlook on life.

Massey suffered a spinal cord injury in a pool accident in March and is paralyzed from the chest down. After months of rehab, he's eager to get back into a familiar routine.

"It's definitely boring," the 21-year-old said at his parents' home in Niceville. "There's not a lot to do. I want to go back to school. I still have my brain. I still have everything I need to be successful."

After the accident March 17, Massey was treated at the University of Florida Shands Hospital and then was transferred to Shepherd Center, a spinal cord and brain injury rehab center in Atlanta. At Shepherd Center he met with a peer mentor, counselors and physical therapists to help him find a new normal.

Jack has remained positive throughout the past six months.

"Jack has been a fighter through all of this," said his mother, Julie. "I think he's done well. I only saw him break down once."

Before the accident, Jack was a well-rounded athlete who playing baseball and basketball and ran. He was a star on the track and field team at Niceville High School, with his 4 X 800 relay winning state his senior year.

He says the biggest challenge now is not being able to do the same things he could before.

"I can't get up and go," he said. "It didn't really start to set in until after I got out of rehab."

Jack has had to find enjoyment in other things, like reading or playing with the dogs. His friends have learned to transfer him from his wheelchair to a car so they can take him to the movies or out to eat. When they recently took a trip to the beach, Julie said five of Jack's friends carried him out to the sand a lesson on how hard it is to navigate the world in a wheelchair.

Jack said he believes technology one day will advance enough that he won't be paralyzed forever. He also volunteered to do stem cell surgery to allow doctors to study the effects of stem cells on his spine for the next 15 years. Instead of wallowing in self-pity, he's moving forward. But he'll need help.

"I'm appreciating everything in the now," he said.

Doctors have said Jack has adapted faster than expected, but there are still some everyday essential tasks that are out of his reach. He cannot write or cook. He can shower himself but can't dry himself or transfer himself in and out of his wheelchair. The Massey family hopes to secure a personal care attendant for Jack at school, but until then Julie will be in Gainesville to help him transition. An occupational therapy student from the university will also help Jack on a temporary basis.

Finding proper care for her son has proven to be a learning experience for Julie and her husband, Lance.

"I don't know how people do it," she said. "We have good health care, but then there's hidden costs. There's travel expenses. ... It's kind of humbling. Nobody should have to go to GoFundMe for medical help."

Jack wants to spend his final year as an undergrad as independent as possible. After months of helping him recover, Julie said it will be hard to let her son go. Jack is the oldest of three; his brother Lance is 19 and a student at UF and his sister Alina is 14 and attends Ruckel Middle School.

"It's like letting him go off to kindergarten again," she said.

As for life after college, Jack said he doesn't feel limited in career choices. One of his professors in the geology department encouraged him by saying that there were plenty of opportunities he could pursue in that field. Jack said he may also consider law school. One thing he's learned through this life-altering experience is that there are no limits to what he can achieve.

"I haven't done that much deep thinking. I just go with the flow," he said. "But I learned I have more perseverance. I'm more mentally tough than I thought I was. I'm appreciative for life in general. That's one of the big things."

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Paralyzed after pool accident, student heads back to college - The Herald

Spinal Cord Stem Cells Comments Off on Paralyzed after pool accident, student heads back to college – The Herald | August 25th, 2017

You might feel a bit down if you watch the news. Who wouldnt?

Angry people might be grabbing headlines and making you wonder about the future, but the antidote is all around you.

Talk to some of your neighbors. Chances are, no matter what they look like or where theyre originally from, youll find theyre actually pretty decent people just like you.

The little improvements we all try to make may not register much, but the accumulation of them all eventually does.

And if theres one tangible piece of proof that the world is changing for the better, its Lucas Lindner.

2016 was not a kind year for 22-year-old Lucas.

Last May he lost control of his pickup truck when a deer ran out on the road. The front passenger tire blew out. The truck rolled, throwing him out of the window.

When he woke up in the hospital, he was paralyzed from the neck down. He was just heading to the grocery store on a Wisconsin Sunday morning.

It was an accident that could happen to anyone, to a friend or relative.

Normally, people like Lucas have no hope of restoring motor control of their bodies ever again.

In the United States, this awful story plays out 17,000 times every year. There are a quarter of a million people in the country with paralysis.

But Lucas story is working out a little bit differently.

Lucas was airlifted to Froedtert Hospital, a teaching hospital of the Medical College of Wisconsin.

There, Dr. Shekar N. Kurpad, professor of neurosurgery, applied 15 years of research into cell transplantation for spinal cord injury.

The procedure revolutionary and so were the cells Dr. Kurpad used.

The new procedure used cells that were developed over many years by researchers at a two companies leading the way in regenerative medicine.

Researchers at these companies have discovered how to grow stem cells and make them reliable for transplantation use.

On doctor, in fact, who Ive researched extensively, has been called the father of regenerative medicine.

Ive had the pleasure of meeting with him on a number of occasions.

Whenever I am in the San Francisco Bay Area, I try to visit him to learn whats going on in the field.

And from what Ive seen the therapeutic potential is hard to understate.

And were starting to see the results in people like Lucas Lindner.

Hes still wheelchair-bound we have a lot more to learn but he now has fine motor skills in his upper body. Thats extraordinary in cases like his.

Lucass miraculous improvement is due to newly designed pluripotent stem cells They are called pluripotent because they have the power to transform into any other cell type in the body.

And this Bay Area doctors company has accumulated the technology to make that happen.

Over the next few months, well get more clinical data from patients being treated with the full 20 million-cell dose and potentially more great news of restored motor function.

The recent headlines may have been about a few angry people rioting and hating each other, but the real important news is this

Recently, when the Cincinnati Reds played the Milwaukee Brewers, Lucas threw out the opening pitch.

Many U.S. presidents and other famous people have thrown pitches, but no pitch has been as historic as this one. And the advances I highlighted today are the reason why.

As this therapy matures and gets closer to market, I believe it will make a big impact on shares of companies in this space.

Which means the right-timed move in the upcoming months means a huge potential windfall of cash for you.

More to come soon.

For Tomorrows Trends Today,

Ray BlancoforThe Daily Reckoning

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A Year Ago He Was Paralyzed From the Neck Down Then This Happened - Daily Reckoning

Spinal Cord Stem Cells Comments Off on A Year Ago He Was Paralyzed From the Neck Down Then This Happened – Daily Reckoning | August 25th, 2017

The idea of bringing people back from the dead could one day be more than just science fiction it could be a reality. Over the past few decades, there has been progress in keeping people alive via advanced surgical techniques, organ transplants, mechanical ventilators and even saving a beating heart that has once stopped. However, when it comes to the injured brain, stem cell therapy may show promise in bringing the brain dead back to life.

In BrainCraft's video, "Ways to Bring the Brain Dead Back to Life" host Vanessa Hill explains the brain is made up of trillions of connections; our life depends on these connections. If the heart stops pumping blood for a few minutes, the brain will fall into a state of frenzy where some neurons starve to death during the blackout and others fight for life. Neurotransmitters spill out neurons in high concentrations, which leads to uncontrollable electrical changes sweeping across the brain, causing toxic chemicals to pile up and burn holes in the membranes of neurons.

All of these events lead to programmed cell death. Neurons start to die one by one, until the brain stops functioning altogether.However, scientists have started to discover the brain does have a small reservoir of stem cells that can generate new neurons.

Researchers have hypothesized whether these cells could be coaxed to turn into new neurons that self-repair the brain's injured tissue. They have also theorized the possibility of injecting neural stem cells into the brain of a patient. So, if it becomes possible to replace dead neurons, it should be possible to resurrect a person via stem cell therapy who just died.

Previous research has shown it's possible to plant stem cells in the brains of mice and help them grow into fully functioning neurons that make connections with their neighbors. In the future, these methods could be used to repair the damage done to the brain by a stroke. Currently, several trials are underway to transplant new neurons into the brains of people with Parkinson's disease.

A Philadelphia-based company, Bioquark, hopes to use stem cells to reverse death by injecting them 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. The ultimate goal is to grow new neurons and spur them to connect to each other, which can potentially bring the brain back to life.

Theres the potential thata cocktail of moleculesto spurr neuronal growth could come in pill form.

This concept does raise a lot of questions, like Will we be a different person if brand new neurons connect differently? Or ,How many cells can be replaced without fully becoming a whole different person?

Stem cells are currently used for a variety of conditions, from stroke to paralysis.

But, there's currently no FDA-approved stem therapy for brain conditions. Scientists are hopeful if this approach worked on mice, it could one day work on humans too.

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The Possible Ways To Bring Brain-Dead Patients Back To Life - Medical Daily

Spinal Cord Stem Cells Comments Off on The Possible Ways To Bring Brain-Dead Patients Back To Life – Medical Daily | August 25th, 2017

The St. Louis-based Washington University School of Medicine is a new clinical study site for Asterias Biotherapeuturics SCiStar clinical trial of AST-OPC1 stem cells in patients with severe cervical spinal cord injuries.

Here are seven takeaways:

1. Patients participating in the trial are categorized into:

AIS-A patients: those who have lost all motor and sensory functions below their injury sites.

AIS-B patients: those who have lost all motor function but have minimal sensory function below their injury site.

2. The stem cells are administered 21 to 42 days post injury and patients are followed by neurological exams and imaging procedures to asses the progress and safety of the trial.

3. W. Zachary Ray, MD, a neurological and orthopedic surgery associate professor at Washington School of Medicine, will lead the site's investigation.

4. Asterias Biotherapeuturics receive FDA clearance to progress its clinical study after phase one of the trial showed five patients with neurologically complete thoracic spinal cord injuries improved motor function after being administered 2 million AST-OPC1 cells.

5. The California Institute for Regenerative Medicine granted Asterias Biotherapeuturics $14.3 million in funding for the clinical trial and other product development activities for AST-OPC1.

6. There are now nine centers across the U.S. participating in the clinical trial.

7. Asterias Biotherapeuturics is a biotechnology company focuses on developing regenerative medicine.

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Washington University School of Medicine new spinal cord injury clinical trial site: 7 takeaways - Becker's Orthopedic & Spine

Spinal Cord Stem Cells Comments Off on Washington University School of Medicine new spinal cord injury clinical trial site: 7 takeaways – Becker’s Orthopedic & Spine | August 24th, 2017