Umbilical Cord Stem Cell Therapy Clinical Trial for Multiple Sclerosis Gets Green Light
By LizaAVILA
Dallas, TX (PRWEB) April 03, 2014
Translational Biosciences, a subsidiary of Medistem Panama, has received the green light for a phase I/II clinical trial using human umbilical cord-derived mesenchymal stem cells (UC-MSC) for multiple sclerosis from the Comit Nacional de Biotica de la Investigacin (CNEI) Institutional Review Board (IRB) in Panama.
According to the US National Multiple Sclerosis Society, in Multiple Sclerosis (MS), an abnormal immune-mediated T cell response attacks the myelin coating around nerve fibers in the central nervous system, as well as the nerve fibers themselves. This causes nerve impulses to slow or even halt, thus producing symptoms of MS that include fatigue; bladder and bowel problems; vision problems; and difficulty walking. The Cleveland Clinic reports that MS affects more than 350,000 people in the United States and 2.5 million worldwide.
Mesenchymal stem cells harvested from donated human umbilical cords after normal, healthy births possess anti-inflammatory and immune modulatory properties that may relieve MS symptoms. Because these cells are immune privileged, the recipients immune system does not reject them. These properties make UC-MSC interesting candidates for the treatment of multiple sclerosis and other autoimmune disorders.
Each patient will receive seven intravenous injections of UC-MSC over the course of 10 days. They will be assessed at 3 months and 12 months primarily for safety and secondarily for indications of efficacy.
The stem cell technology being utilized in this trial was developed by Neil Riordan, PhD, founder of Medistem Panama. The stem cells will be harvested and processed at Medistem Panamas 8000 sq. ft. ISO-9001 certified laboratory in the prestigious City of Knowledge. They will be administered at the Stem Cell Institute in Panama City, Panama.
From his research laboratory in Dallas, Texas, Dr. Riordan commented, Umbilical cord tissue provides an abundant, non-controversial supply of immune modulating mesenchymal stem cells. Preclinical and clinical research has demonstrated the anti-inflammatory and immune modulating effects of these cells. We look forward to the safety and efficacy data that will be generated by this clinical trial; the first in the western hemisphere testing the effects of umbilical cord mesenchymal stem cells on patients with multiple sclerosis.
The Principle Investigator is Jorge Paz-Rodriguez, MD. Dr. Paz-Rodriguez also serves as the Medical Director at the Stem Cell Institute.
For detailed information about this clinical trial visit http://www.clinicaltrials.gov . If you are a multiple sclerosis patient between the ages of 18 and 55, you may qualify for this trial. Please email trials (at) translationalbiosciences (dot) com for more information about how to apply.
About Translational Biosciences
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Umbilical Cord Stem Cell Therapy Clinical Trial for Multiple Sclerosis Gets Green Light
Better way to grow motor neurons from stem cells
By NEVAGiles23
Researchers report they can generate human motor neurons from stem cells much more quickly and efficiently than previous methods allowed. The finding, described in Nature Communications, will aid efforts to model human motor neuron development, and to understand and treat spinal cord injuries and motor neuron diseases such as amyotrophic lateral sclerosis (ALS).
The new method involves adding critical signaling molecules to precursor cells a few days earlier than previous methods specified. This increases the proportion of healthy motor neurons derived from stem cells (from 30 to 70 percent) and cuts in half the time required to do so.
"We would argue that whatever happens in the human body is going to be quite efficient, quite rapid," said University of Illinois cell and developmental biology professor Fei Wang, who led the study with visiting scholar Qiuhao Qu and materials science and engineering professor Jianjun Cheng. "Previous approaches took 40 to 50 days, and then the efficiency was very low -- 20 to 30 percent. So it's unlikely that those methods recreate human motor neuron development."
Qu's method produced a much larger population of mature, functional motor neurons in 20 days.
The new approach will allow scientists to induce mature human motor neuron development in cell culture, and to identify the factors that are vital to that process, Wang said.
Stem cells are unique in that they can adopt the shape and function of a variety of cell types. Generating neurons from stem cells (either embryonic stem cells or those "induced" to revert back to an embryo-like state) requires adding signaling molecules to the cells at critical moments in their development.
Wang and other colleagues previously discovered a molecule (called compound C) that converts stem cells into "neural progenitor cells," an early stage in the cells' development into neurons. But further coaxing these cells to become motor neurons presented unusual challenges.
Previous studies added two important signaling molecules at Day 6 (six days after exposure to compound C), but with limited success in generating motor neurons. In the new study, Qu discovered that adding the signaling molecules at Day 3 worked much better: The neural progenitor cells quickly and efficiently differentiated into motor neurons.
This indicates that Day 3 represents a previously unrecognized neural progenitor cell stage, Wang said.
The new approach has immediate applications in the lab. Watching how stem cells (derived from ALS patients' own skin cells, for example) develop into motor neurons will offer new insights into disease processes, and any method that improves the speed and efficiency of generating the motor neurons will aid scientists. The cells can also be used to screen for drugs to treat motor neuron diseases, and may one day be used therapeutically to restore lost function.
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Better way to grow motor neurons from stem cells
Team finds a better way to grow motor neurons from stem cells
By JoanneRUSSELL25
PUBLIC RELEASE DATE:
1-Apr-2014
Contact: Diana Yates diya@illinois.edu 217-333-5802 University of Illinois at Urbana-Champaign
CHAMPAIGN, Ill. Researchers report they can generate human motor neurons from stem cells much more quickly and efficiently than previous methods allowed. The finding, described in Nature Communications, will aid efforts to model human motor neuron development, and to understand and treat spinal cord injuries and motor neuron diseases such as amyotrophic lateral sclerosis (ALS).
The new method involves adding critical signaling molecules to precursor cells a few days earlier than previous methods specified. This increases the proportion of healthy motor neurons derived from stem cells (from 30 to 70 percent) and cuts in half the time required to do so.
"We would argue that whatever happens in the human body is going to be quite efficient, quite rapid," said University of Illinois cell and developmental biology professor Fei Wang, who led the study with visiting scholar Qiuhao Qu and materials science and engineering professor Jianjun Cheng. "Previous approaches took 40 to 50 days, and then the efficiency was very low 20 to 30 percent. So it's unlikely that those methods recreate human motor neuron development."
Qu's method produced a much larger population of mature, functional motor neurons in 20 days.
The new approach will allow scientists to induce mature human motor neuron development in cell culture, and to identify the factors that are vital to that process, Wang said.
Stem cells are unique in that they can adopt the shape and function of a variety of cell types. Generating neurons from stem cells (either embryonic stem cells or those "induced" to revert back to an embryo-like state) requires adding signaling molecules to the cells at critical moments in their development.
Wang and other colleagues previously discovered a molecule (called compound C) that converts stem cells into "neural progenitor cells," an early stage in the cells' development into neurons. But further coaxing these cells to become motor neurons presented unusual challenges.
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Team finds a better way to grow motor neurons from stem cells
$2.5 million Defense Department grant funds gene therapy study for Lou Gehrig's disease
By Dr. Matthew Watson
PUBLIC RELEASE DATE:
1-Apr-2014
Contact: Sandy Van sandy@prpacific.com 808-526-1708 Cedars-Sinai Medical Center
LOS ANGELES (April 1, 2014) The Cedars-Sinai Regenerative Medicine Institute has received a $2.5 million grant from the Department of Defense to conduct animal studies that, if successful, could provide the basis for a clinical trial of a gene therapy product for patients with Lou Gehrig's disease, also called amyotrophic lateral sclerosis, or ALS.
The incurable disorder attacks muscle-controlling nerve cells motor neurons in the brain, brainstem and spinal cord. As the neurons die, the ability to initiate and control muscle movement is lost. Patients experience muscle weakness that steadily leads to paralysis; the disease usually is fatal within five years of diagnosis. Several genes have been identified in familial forms of ALS, but most cases are caused by a complex combination of unknown genetic and environmental factors, experts believe.
Because ALS affects a higher-than-expected percentage of military veterans, especially those returning from overseas duties, the Defense Department invests $7.5 million annually to search for causes and treatments. The Cedars-Sinai study, led by Clive Svendsen, PhD, professor and director of the Regenerative Medicine Institute at Cedars-Sinai Medical Center, and Genevive Gowing, PhD, a senior scientist in his laboratory, also will involve a research team at the University of Wisconsin, Madison and a Netherlands-based biotechnology company, uniQure, that has extensive experience in human gene therapy research and development.
The research will be conducted in laboratory rats bred to model a genetic form of ALS. If successful, it could have implications for patients with other types of the disease and could translate into a gene therapy clinical trial for this devastating disease.
It centers on a protein, GDNF, that promotes the survival of neurons. In theory, transporting GDNF into the spinal cord could protect neurons and slow disease progression, but attempts so far have failed, largely because the protein does not readily penetrate into the spinal cord. Regenerative Medicine Institute scientists previously showed that spinal transplantation of stem cells that were engineered to produce GDNF increased motor neuron survival, but this had no functional benefit because it did not prevent nerve cell deterioration at a critical site, the "neuromuscular junction" the point where nerve fibers connect with muscle fibers to stimulate muscle action.
Masatoshi Suzuki, PhD, DVM, assistant professor of comparative biosciences at the University of Wisconsin, Madison, who previously worked in the Svendsen Laboratory and remains a close collaborator, recently found that stem cells derived from human bone marrow and engineered to produce GDNF protected nerve cells, improved motor function and increased lifespan when transplanted into muscle groups of a rat model of ALS.
"It seems clear that GDNF has potent neuroprotective effects on motor neuron function when the protein is delivered at the level of the muscle, regardless of the delivery method. We think GDNF will be able to help maintain these connections in patients and thereby keep the motor neuron network functional," Suzuki said.
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$2.5 million Defense Department grant funds gene therapy study for Lou Gehrig's disease
Ancient Virus DNA Gives Stem Cells the Power to Transform
By Dr. Matthew Watson
Charles Q. Choi
A virus that invaded the genomes of humanity's ancestors millions of years ago now plays a critical role in the embryonic stem cells from which all cells in the human body derive, new research shows.
The discovery sheds light on the role viruses play in human evolution and could help scientists better understand how to use stem cells in advanced therapies or even how to convert normal cells into stem cells.
Embryonic stem cells are pluripotent, meaning they are capable of becoming any other kind of cell in the body. Scientists around the world hope to use this capability to help patients recover from injury and disease.
Researchers have struggled for decades to figure out how pluripotency works. These new findings reveal that "material from viruses is vital in making human embryonic stem cells what they are," said computational biologist Guillaume Bourque at McGill University in Montreal, a co-author of the study published online March 30 in Nature Structural & Molecular Biology.
Viral Invasion
To make copies of itself, a virus has to get inside a cell and co-opt its machinery. When one type of virus called a retrovirus does this, it slips its own genes into the DNA of its host cell. The cell is then tricked into assembling new copies of the retrovirus. The most infamous retrovirus is HIV, the virus behind AIDS.
In rare cases, retroviruses infect sperm or egg cells. If that sperm or egg becomes part of a person, their cells will contain retrovirus DNA, and they can pass that DNA on to their descendants. Past research suggests that at least 8 percent of the human genome is composed of these so-called endogenous retroviruses-leftovers from retroviral infections our ancestors had millions of years ago.
Scientists long thought that endogenous retroviruses were junk DNA that didn't do anything within the human genome, said study co-author Huck-Hui Ng, a molecular biologist at the Genome Institute of Singapore.
However, recent studies have revealed that might not be true for one class of endogenous retroviruses known as human endogenous retrovirus subfamily H. HERV-H DNA was surprisingly active in human embryonic stem cells but not in other regular types of human cells.
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Ancient Virus DNA Gives Stem Cells the Power to Transform
Study Shows Neuralstem Cells Transplanted Into Brain Significantly Improve Post-Stroke Symptoms in Rats
By NEVAGiles23
Brother describes pulling mudslide victim's body from car
By Jonathan Kaminsky DARRINGTON, Washington (Reuters) - Days after risking his own life and defying arrest by joining the search for Washington state mudslide victims in a vast, mucky debris field near Oso, Dayn Brunner retrieved the body of the No. 1 person he had been looking for - his sister. Brunner, 42, recounted the tragic coincidence in an interview with Reuters on Friday, two days after it unfolded on the enormous mound of mud and rubble left by last Saturday's disaster, which has claimed at least 26 lives and left 90 people still missing. Brunner said he was on the mud pile on Wednesday afternoon when other rescue workers found a blue object and called him over to the spot. It was the same color as the car his sister, Summer Raffo, 36, was known to have been driving through the area when the slide struck.
The Repair Stem Cells Institute Announces Its Special …
By LizaAVILA
03:00 EDT 26 Mar 2014 | PR Web
RSCIs one-day treatment program in Florida, USA, is priced to bring stem cell treatment benefits to the greatest possible number of SCI patients.
Dallas, TX (PRWEB) March 26, 2014
The Repair Stem Cells Institute (RSCI http://www.repairstemcells.org) announces its new Double Benefits for SCI stem cell treatment program specifically to benefit sufferers of Spinal Cord Injuries (SCI). The Regenerative Center, headed by Dr. Melvin M. Propis, a well-known practitioner of stem cells science, is located in Ft. Lauderdale, Florida, U.S.A. RSCIs program is by far the least expensive SCI treatment program available using real stem cells treatments within FDA regulations.
A Spinal Cord Injury (SCI) refers to any injury to the spinal cord caused by trauma rather than disease. Depending on where the spinal cord and nerve roots are damaged, the symptoms can vary widely, from pain to paralysis to incontinence. SCIs are described as "incomplete," which normally means a partial but significant paralysis, to a "complete" injury, which means a total loss of function. The number of people in the United States in 2014 who have SCI has been estimated at over a quarter million, with approximately 12,000 new cases each year.
The Repair Stem Cells Institute is the worlds only stem cell patients advocacy group whose mission is to Educate, Advocate, and Empower people to make educated choices about their medical conditions and treatments in order to lead longer and more fulfilling lives. The Double Benefits for SCI program marks a milestone in RSCIs seven years of educating thousands and guiding hundreds to adult stem cell therapies by the worlds most competent stem cells doctors at 14 affiliated international stem cell treatment centers.
Highlights of RSCIs stem cell treatment for Spinal Cord Injury include:
An RSCI Spinal Cord Injury patient, Graham Faught, who received treatment in 2013 at the Florida treatment clinic, said, This treatment literally got me back on my feet. In April, I was confined to a wheelchair with little hope. By December, I was upright again, making some progress on the treadmill and hopeful for the future. Late Flash: March 20, Graham walked 20 feet with a walker. We expect to have videos soon.
Don Margolis, founder and chairman of the Repair Stem Cells Institute (http://www.repairstemcells.org), stated, We at RSCI are very proud to offer this incredible program for SCI patients. We are confident that it will be in the forefront of many more such treatment breakthroughs. Our next target for the summer of 2014 is a double for Multiple Sclerosis, hopefully at the same price!
Currently, adult stem cell treatments are being used to help patients recover from over 150 debilitating chronic conditions previously thought to be untreatable, including the Big Three Heart Disease, Diabetes, and Cancer -- as well as Alzheimers, Parkinsons, Spinal Cord Injury, Liver Disease, Cerebral Palsy, Renal Failure, Arthritis, Autism, and Diabetes. A full list of diseases stem cells can help can be found on the RSCI website (http://www.repairstemcells.org). To date, commercial stem cell treatments have been used by over 30,000 patients with a 65% success rate.
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The Repair Stem Cells Institute Announces Its Special ...
The Repair Stem Cells Institute Announces Its Special Double Benefits for SCI Stem Cells Treatment Program to …
By LizaAVILA
Dallas, TX (PRWEB) March 26, 2014
The Repair Stem Cells Institute (RSCI http://www.repairstemcells.org) announces its new Double Benefits for SCI stem cell treatment program specifically to benefit sufferers of Spinal Cord Injuries (SCI). The Regenerative Center, headed by Dr. Melvin M. Propis, a well-known practitioner of stem cells science, is located in Ft. Lauderdale, Florida, U.S.A. RSCIs program is by far the least expensive SCI treatment program available using real stem cells treatments within FDA regulations.
A Spinal Cord Injury (SCI) refers to any injury to the spinal cord caused by trauma rather than disease. Depending on where the spinal cord and nerve roots are damaged, the symptoms can vary widely, from pain to paralysis to incontinence. SCIs are described as "incomplete," which normally means a partial but significant paralysis, to a "complete" injury, which means a total loss of function. The number of people in the United States in 2014 who have SCI has been estimated at over a quarter million, with approximately 12,000 new cases each year.
The Repair Stem Cells Institute is the worlds only stem cell patients advocacy group whose mission is to Educate, Advocate, and Empower people to make educated choices about their medical conditions and treatments in order to lead longer and more fulfilling lives. The Double Benefits for SCI program marks a milestone in RSCIs seven years of educating thousands and guiding hundreds to adult stem cell therapies by the worlds most competent stem cells doctors at 14 affiliated international stem cell treatment centers.
Highlights of RSCIs stem cell treatment for Spinal Cord Injury include:
An RSCI Spinal Cord Injury patient, Graham Faught, who received treatment in 2013 at the Florida treatment clinic, said, This treatment literally got me back on my feet. In April, I was confined to a wheelchair with little hope. By December, I was upright again, making some progress on the treadmill and hopeful for the future. Late Flash: March 20, Graham walked 20 feet with a walker. We expect to have videos soon.
Don Margolis, founder and chairman of the Repair Stem Cells Institute (http://www.repairstemcells.org), stated, We at RSCI are very proud to offer this incredible program for SCI patients. We are confident that it will be in the forefront of many more such treatment breakthroughs. Our next target for the summer of 2014 is a double for Multiple Sclerosis, hopefully at the same price!
Currently, adult stem cell treatments are being used to help patients recover from over 150 debilitating chronic conditions previously thought to be untreatable, including the Big Three Heart Disease, Diabetes, and Cancer -- as well as Alzheimers, Parkinsons, Spinal Cord Injury, Liver Disease, Cerebral Palsy, Renal Failure, Arthritis, Autism, and Diabetes. A full list of diseases stem cells can help can be found on the RSCI website (http://www.repairstemcells.org). To date, commercial stem cell treatments have been used by over 30,000 patients with a 65% success rate.
For more information about adult stem cells, stem cell treatment, diseases stem cells can help, and the top international stem cell treatment centers, the the Repair Stem Cells Institute website offers a wealth of straightforward and unbiased information and solutions.
Contact: Don Margolis Repair Stem Cells Institute 3010 LBJ Freeway, Suite 1200 Dallas, TX 75234 Tel: (214) 556-6377 Email: info(at)repairstemcells(dot)org Website: http://www.repairstemcells.org Facebook: http://www.facebook.com/repairstemcells Twitter: http://www.twitter.com/repairstem
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The Repair Stem Cells Institute Announces Its Special Double Benefits for SCI Stem Cells Treatment Program to ...
Wounded Pa. soldier seeks Chinese stem cell cure
By LizaAVILA
YORK, Pa. (AP) - A York County soldier left partially paralyzed when he was shot in Afghanistan nearly two years ago is banking on stem cells to help him regain movement.
Matthew Hanes, 22, of Manchester Township will head to China in April to undergo surgery to repair part of his damaged spinal cord.
Doctors essentially will use minor surgery and stem cell therapy to build a bridge over two vertebrae that were shattered when Hanes was shot.
At the minimum Ill get at least some feeling back where I dont have it in certain places, but I could get everything back if it goes well, Hanes said.
U.S. Army Cpl. Hanes was shot while on patrol in Afghanistan in June 2012. He was left with limited use of his upper body and no use of his lower extremities.
RESEARCH: Soon after he returned to the U.S., Hanes began researching stem cell therapy as possible treatment.
Thats how he found Puhua International Hospital in Beijing, where he will fly on April 1 for the treatment. Hes slated to return stateside later that month.
Its coming up slowly now that I know its on, Hanes said.
During his research, Hanes said he found the U.S. is so far behind on stem cell research compared to some countries in Asia, such as China, and Europe.
For years, the federal government imposed tight restrictions on stem cell research until it was loosened in 2009 by President Barrack Obama.
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Wounded Pa. soldier seeks Chinese stem cell cure
Stem cells from muscle can repair nerve damage after injury, Pitt researchers show
By daniellenierenberg
PUBLIC RELEASE DATE:
18-Mar-2014
Contact: Anita Srikameswaran 412-578-9193 University of Pittsburgh Schools of the Health Sciences
PITTSBURGH, March 18, 2014 Stem cells derived from human muscle tissue were able to repair nerve damage and restore function in an animal model of sciatic nerve injury, according to researchers at the University of Pittsburgh School of Medicine. The findings, published online today in the Journal of Clinical Investigation, suggest that cell therapy of certain nerve diseases, such as multiple sclerosis, might one day be feasible.
To date, treatments for damage to peripheral nerves, which are the nerves outside the brain and spinal cord, have not been very successful, often leaving patients with impaired muscle control and sensation, pain and decreased function, said senior author Johnny Huard, Ph.D., professor of orthopaedic surgery, and Henry J. Mankin Chair in Orthopaedic Surgery Research, Pitt School of Medicine, and deputy director for cellular therapy, McGowan Institute for Regenerative Medicine.
"This study indicates that placing adult, human muscle-derived stem cells at the site of peripheral nerve injury can help heal the lesion," Dr. Huard said. "The stem cells were able to make non-neuronal support cells to promote regeneration of the damaged nerve fiber."
The researchers, led by Dr. Huard and Mitra Lavasani, Ph.D., first author and assistant professor of orthopaedic surgery, Pitt School of Medicine, cultured human muscle-derived stem/progenitor cells in a growth medium suitable for nerve cells. They found that, with prompting from specific nerve-growth factors, the stem cells could differentiate into neurons and glial support cells, including Schwann cells that form the myelin sheath around the axons of neurons to improve conduction of nerve impulses.
In mouse studies, the researchers injected human muscle-derived stem/progenitor cells into a quarter-inch defect they surgically created in the right sciatic nerve, which controls right leg movement. Six weeks later, the nerve had fully regenerated in stem-cell treated mice, while the untreated group had limited nerve regrowth and functionality. Twelve weeks later, treated mice were able to keep their treated and untreated legs balanced at the same level while being held vertically by their tails. When the treated mice ran through a special maze, analyses of their paw prints showed eventual restoration of gait. Treated and untreated mice experienced muscle atrophy, or loss, after nerve injury, but only the stem cell-treated animals had regained normal muscle mass by 72 weeks post-surgery.
"Even 12 weeks after the injury, the regenerated sciatic nerve looked and behaved like a normal nerve," Dr. Lavasani said. "This approach has great potential for not only acute nerve injury, but also conditions of chronic damage, such as diabetic neuropathy and multiple sclerosis."
Drs. Huard and Lavasani and the team are now trying to understand how the human muscle-derived stem/progenitor cells triggered injury repair, as well as developing delivery systems, such as gels, that could hold the cells in place at larger injury sites.
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Stem cells from muscle can repair nerve damage after injury, Pitt researchers show
Spinal cord injuries: how could stem cells help? | Europe …
By JoanneRUSSELL25
Introducing the spinal cord
The spinal cord is the delicate tissue encased in and protected by the hard vertebrae of the spinal column. Together the brain and spinal cord form the bodys central nervous system.
The spinal cord is made up of millions of nerve cells that carry signals to and from the brain and out into other parts of the body. The information that allows us to sit, run, go to the toilet and breathe travels along the spinal cord.
The main cell type found in the spinal cord, the neuron, conveys information up and down the spinal cord in the form of electrical signals. An axon(also known as a nerve fibre) is a long, slender projection of a neuron that conducts these signals away from the neuron's cell body. Each neuron has only one axon, and it can be as long as the entire spinal cord, up to 45cm in an adult human.
The axons that carry messages down the spinal cord (from the brain) are called motor axons. They control the muscles of internal organs (such as heart, stomach, intestines) and those of the legs and arms. They also help regulate blood pressure, body temperature, and the bodys response to stress.
The axons that travel up the cord (to the brain) carry sensory information from the skin, joints and muscles (touch, pain, temperature) and from internal organs (such as heart and lungs). These are the sensory axons.
Neurons in the spinal cord also need the support of other cell types. The oligodendrocyte, for example, forms structures that wrap around and insulate the axon. Called myelin, this insulating material helps the electrical impulse to flow quickly and efficiently down the axon.
A spinal cord injury affects both neurons and the myelin sheath that insulates axonsWhen the spinal cord is injured, the initial trauma causes cell damage and destruction, and triggers a cascade of eventsthat spread around the injury site affecting a number of different types of cells. Axons are crushed and torn, and oligodendrocytes, the nerve cells that make up the insulating myelin sheath around axons, begin to die. Exposed axons degenerate, the connection between neurons is disrupted and the flow of information between the brain and the spinal cord is blocked.
The spine has different sections. The level of paralysis depends on the location of the injury.
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Spinal cord injuries: how could stem cells help? | Europe ...
Final Results Of Neuralstem Phase I Stem Cell Trial In Amyotrophic Lateral Sclerosis Published In Annals of Neurology
By LizaAVILA
Neuralstem Logo. (PRNewsFoto/NEURALSTEM, INC.)
ROCKVILLE, Md., March 17, 2014 /Emag.co.uk/ Neuralstem, Inc. (NYSE MKT: CUR) announced that the final results from the Phase I safety trial using NSI-566 spinal cord stem cells in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrigs disease) were published in the peer-reviewed journal, Annals of Neurology http://onlinelibrary.wiley.com/doi/10.1002/ana.24113/full. In Intraspinal Neural Stem Cell Transplantation in Amyotrophic Lateral Sclerosis: Phase I Trial Outcomes, results were updated from Phase I interim data, reported earlier, to include data from the last six patients in the trial. These six patients were the first to receive cervical stem cell transplants. Three of them were also the first to be transplanted along the length of their spines, in both the lumbar and the cervical regions. The results showed that NSI-566 human spinal cord stem cells can be safely transplanted in both the lumbar and cervical spinal cord segments, did not accelerate disease progression, and warrant further study on dosing and therapeutic efficacy. Furthermore, the researchers were able to identify potential therapeutic windows, suggesting that more injections, as well as multiple injections, are better and may increase both the length and the magnitude of the potential benefits. This is consistent with the hypothesized neuroprotective mechanism-of-action for this cell therapy.
Photo Since concluding Phase I, the trial has progressed to Phase II at three centers, Emory University Hospital in Atlanta, Georgia, the ALS Clinic at the University of Michigan Health System, in Ann Arbor, Michigan, and Massachusetts General Hospital in Boston, Massachusetts, which treated its first patient in February. Treatment of three of the five Phase II cohorts has been completed.
Although this was a Phase I trial, and functional outcome data were collected for the purpose of assessing safety, we performed secondary analyses of these data as a means to gain insight into how cellular transplantation affected disease progression rates and to inform outcome assessment approaches in future trial phases, said Eva Feldman, MD, PhD, Director of the A. Alfred Taubman Medical Research Institute, Director of Research of the ALS Clinic at the University of Michigan Health System, principle investigator for the NSI-566/ALS trial and lead author. Dr. Feldman is also an unpaid consultant to Neuralstem.
Pre-surgical disease progression rates for the various functional outcome measures were calculated to create slopes for each patient, so that we could determine if post-surgical data points, at 6, 9, 12 and 15 months, improved relative to predicted points. We also did analyses to determine which, if any, functional outcome assessment most closely correlated with the overall ALSFRS-R scores, said Dr. Feldman. Comparison of the outcome data to predicted outcome points in group E (patients who received both lumbar and cervical injections) revealed improvements in a significant number of measures at 6, 9, 12 and 15 months post-surgery. Overall, 50% of the patients in the trial showed improvement across multiple clinical measures at the same time points. We also found that a measure of grip strength correlated most closely with the overall ALSFRS-R scores.
Dr. Feldman added, Finally, we conducted an analysis to identify the most biologically active period of the injected cells for the patients receiving both lumbar and cervical injections. This analysis reveals that the maximal periods of benefit correlate with the two surgical interventions. Importantly, as the bell-shaped curve associated with each intervention is likely due to disease progression, increasing the total cell dose, and applying multiple applications of these stem cells, may increase both the length and magnitude of the potential benefit. We are of course exploring this very dosing regimen in our ongoing Phase II trial.
The completion of this Phase I study is a major milestone for the testing of intraspinal stem cell therapy for ALS, said Jonathan Glass, MD, Professor of Neurology and Pathology, Emory University School of Medicine and Director of the Emory ALS Center, site principal investigator and a senior study author. We have now shown that the procedure is safe for both lumbar and cervical injections, allowing us to move forward with an aggressive program to test whether this treatment will improve the course of disease for patients with ALS.
This peer-reviewed article is the first such report of cervical and dual-targeted intraspinal transplantation of neural stem cells in ALS subjects, said Karl Johe, PhD, Neuralstems Chairman of the Board and Chief Scientific Officer. We believe our cells offer a means to replace lost cells, provide neurotrophic support, and improve the diseased microenvironment. This study demonstrates these factors, and that the cells and the novel surgical route of administration are safe and well-tolerated. Our ability to directly inject cells into the cervical regions of the spinal cord represents a significant advance in the field of cell therapy.
We would like to thank the incredible teams at both Michigan and Emory who made this study possible, and who continue working with us today in our ongoing Phase II trial. Wed like to give special thanks to Dr. Jonathan Glass, Director of the Emory ALS Center, the Emory site principle investigator, and Dr. Nick Boulis, Associate Professor of Neurosurgery at Emory School of Medicine, the surgeon for all of the Phase I surgeries, and the inventor of the spinal-mounted stabilization and injection platform and floating cannula surgical devices used to deliver the cells, concluded Dr. Johe.
About Neuralstem
Stem Cell Research in pursuit of Spinal Cord Injury …
By Sykes24Tracey
(Page 1 of 2)
Because neurons (nerve cells) in the central nervous system (the brain and spinal cord) do not repair or replace themselves after being injured, researchers are investigating whether transplanting cells into an injured area can restore function.
One of the many challenges for researchers is obtaining cells that will function as neurons in the brain or spinal cord. Because a persons body doesnt have spare neurons for transplantation, efforts are being made to find other cells that can be transformed into neurons. One potential source is stem cells from human embryos. Less than a week after conception cells in an embryo begin to differentiate that is, they begin to form specific types of cells, such as bone cells, red blood cells, heart muscle cells, and so on. Stem cells are simply cells that can differentiate into other types of cells. Early in the life of an embryo stem cells have the potential to differentiate into the more than two hundred types of cells in a human body. There are other kinds of stem cells, including stem cells in adults, which can differentiate into a more limited number of types of cells.
Using embryonic stem cells for transplantation is controversial because it is necessary to first create human embryos to produce the stem cells and then kill the embryos in the process of harvesting the stem cells. Opponents of the process contend that it is unethical or immoral to create and then kill any form of human life for the purpose of harvesting stem cells. Proponents of stem cell transplantation either claim that embryos created in a laboratory have no value or significance apart from producing stem cells or that the end of helping injured or ill people justifies the means of creating and then killing human life.
Apart from the controversy about creating and killing human embryos, stem cell researchers are faced with another challenge which is partly practical and partly ethical. The bodys immune system recognizes what is part of the body and what is not. Every cell in the body has protein molecules on the surface of the cell wall that identify the cell as being part of the body (these are known as human leukocyte antigens (HLA)). These markers are recognized by the cells in our immune systems. If the immune system doesnt detect the bodys specific markers, it will sound the alarm and go on the attack. This allows our immune system to recognize and fight invaders in the form of bacteria, viruses, and fungi, protecting us from diseases that would otherwise kill us.
However, this same ability of the immune system presents a serious problem when tissue from another person (or animal) is transplanted into the body. The immune system will ordinarily identify the transplant as foreign and begin to attack it. The attack is carried out by cells using chemical weapons that can kill other cells. This process is known as transplant rejection.
To prevent rejection two different strategies have been used. One is to find a transplant donor who has genetic markers (HLA) that are similar to those of the person receiving the transplant. The more similar the markers, the less likely it is that the immune system will reject the transplant. The other strategy is to administer drugs to transplant recipients that suppress the ability of the immune system to recognize and target transplants for destruction. While these drugs usually work, they have numerous side-effects and can make an individual more vulnerable to infections. Often times both strategies are used.
One potential solution to the problem of transplant rejection would be to create a transplant with markers identical to those of the person receiving the transplant. A persons DNA contains the unique blueprint for that persons body, including the details for the markers (HLA) that are recognized by the immune system. Some researchers are attempting to insert human DNA into cells that are then used to create human embryos. This process is known as cloning that is, artificially producing another organism with DNA that is identical to the DNA of the donor. Cloning has been performed with some types of animals but not with a human being(1). If human cloning is eventually successful, the clone would have markers identical to those of the DNA donor. This would potentially allow transplants to be created with the DNA of the patient, which would be recognized by the immune system as belonging to the body. There would be no potential for transplant rejection and no need for drugs to suppress the immune system.
However, even if cloning is successful, researchers will still need to learn how to stimulate an embryonic stem cell to produce a neuron rather than a skin cell or some other type of cell. Transplanting undifferentiated stem cells runs the risk of creating a tumor, an event which has actually occurred when embryonic stem cells have been transplanted into mice. Furthermore, while finding a source of cells that can differentiate into neurons is one major challenge in developing a cure for spinal cord injuries, there are others (click on the Treatments for the Future link under the Spinal Injury Treatment tab.) Consequently, any effective treatment to repair spinal cord injuries using embryonic stem cells lies years, if not a decade or more, in the future.
Cloning is one example of genetic engineering, an activity in which people manipulate DNA to create organisms that wouldnt otherwise exist in nature. While the first mammal (Dolly the sheep) was cloned in 1997, some clones have had health problems not characteristic of the species (including Dolly), are more prone to have offspring with birth defects, or have much shorter than normal life spans. The long term results of cloning are not known. As a result, ethical issues abound, and particularly when human cloning is the issue.
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Stem Cell Research in pursuit of Spinal Cord Injury ...
New findings on neurogenesis in spinal cord
By LizaAVILA
Research from Karolinska Institutet in Sweden suggests that the expression of the so called MYC gene is important and necessary for neurogenesis in the spinal cord. The findings are being published in the journal EMBO Reports.
The MYC gene encodes the protein with the same name, and has an important role in many cellular processes such as proliferation, metabolism, cell death and the potential of differentiation from immature stem cells to different types of specialized cells. Importantly it is also one of the most frequently activated genes in human cancer.
Previously MYC has been shown to promote proliferation and inhibit differentiation in dissociated cells in culture. However, in the current study researchers demonstrate that in the intact neural tissue from chickens, MYC promotes differentiation of neural cells rather than their proliferation.
"We hope that this news knowledge can be important for developing future strategies to promote nerve cell development, for example in patients with spinal cord injuries," says principal investigator Marie Arsenian Henriksson, professor at the Department of Microbiology, Tumor and Cell Biology at Karolinska Institutet.
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The above story is based on materials provided by Karolinska Institutet. Note: Materials may be edited for content and length.
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New findings on neurogenesis in spinal cord
Hot on the trail of cellular metabolism: Researchers unravel the function of cell proteins
By NEVAGiles23
14 hours ago This image shows an embryonic stem cell differentiating into a neuronal cell. Credit: Anne Rupprecht/Vetmeduni Vienna
Cells have a metabolism that can be altered according to its function. If cellular metabolism is disturbed, it can lead to disease of the entire organism. Researchers at the Vetmeduni Vienna discovered that the uncoupling proteins UCP2 and UPC4 are involved in different types of cellular metabolism. As a result, cell alterations can now be detected much earlier than was thus far possible. This research work was recently published in the PLOS ONE journal.
UCPs or uncoupling proteins are present in mitochondria, the powerhouse of each cell in the body. The functions of most of the five known UCPs remain mysterious (UCP2-UCP5), whereby only the distinct function for UCP1 has thus far been discovered. UCP1 is responsible for heat production when muscle activity is deficient such as is the case with babies and animals in hibernation. The research team at the Department of Physiology and Biophysics at the University of Veterinary Medicine in Vienna were able to provide a fundamental explanatory concept for the function of UCP2 and UPC4 for the first time. Each of these proteins are involved in different types of cell metabolism.
UCP2 in Stem Cells and Cancer Cells
In earlier studies of immune cells, lead author, Anne Rupprecht, had already shown that UCP2 could be involved in increased metabolism. Embryonic stem cells precisely exhibit such an increased metabolism, as they rapidly and continually divide, just like cancer cells. Rupprecht searched for various UCPs in embryonic stem cells of mice and in effect found UCP2. "Very high amounts of UCP2 even indicated an especially strong increase in metabolism. In other studies UCP2 had also already been detected in cancer cells", according to Rupprecht.
UCP4 in Nerve Cells
In contrast to UCP2, UCP4 is only found in nerve cells. Nerve cells have a completely different metabolism. They seldom divide, unlike stem cells and cancer cells. The research team of Prof. Elena Pohl therefore examined embryonic stem cells that differentiated to nerve cells in culture. On the basis of this model system, the researchers could show that UCP2 is still existent in the quickly reproducing stem cells, yet at the moment of differentiation are replaced by UPC4.
"In our work, we have examined the natural process of cell differentiation from stem cells to neurons. We know that metabolism changes during differentiation. The fact that we found UCP2 in one case and in the other UCP4 proves for the first time that these proteins are associated with varying types of cell metabolism", specified Elena Pohl.
The researchers, for example, found only UCP2 in neuroblastoma cells - nerve cells that have malignant changes. UCP4, the usual protein of nerve cells was not detectable. UPC4 apparently got lost in the changed nerve cells that were on their way to becoming rapidly reproductive cancer cells.
UCPs for early detection of disease
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Hot on the trail of cellular metabolism: Researchers unravel the function of cell proteins
CIRM Stem Cell Research Updates: Team tricked scar tissue …
By Sykes24Tracey
They used a process similar to one they used in an earlier project published last September where they reported creating neural networks in the brains of mice. In both cases the researchers reprogrammed the nerve support cells known as astrocytes into functional nerves. Astrocytes tend to be abundant, particularly at the site of injury where they proliferate and form scar tissue that actually prevents regrowth of the damaged nerves.
The Texas teams first step involved using a biologic substance to manipulate the expression of genes in the astrocytes at the site of spinal injury in the mice. They tried 12 different ones before they found one that is efficient in turning the protective cells into progenitor cells for nerves; think of them as middlemen between nerve stem cells and adult nerve. They then used a common drug called valproic acid to encourage those progenitor cells to mature into functioning nerves.
The work seems to map out a strategy to get new nerve growth directly in patients, or in vivo. The paper was published in Nature Communication and a press release from the university was picked up by ScienceCodex and it quoted the senior researcher Chun-Li Zhang on the impact:
You can read about some of CIRMs dozens of projects trying to repair or regrow nerve cells in our stem cells and stroke fact sheet.
Don Gibbons
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CIRM Stem Cell Research Updates: Team tricked scar tissue ...
Nygrd uses stem cells to pursue immortality
By Dr. Matthew Watson
The video begins like a clip from a James Bond movie, where the billionaire tycoon announces his plan to save humanity.
"Since the dawn of time, great men have challenged the status quo and dared to dream," an off-screen female narrator says in a sultry British accent while images of Leonardo da Vinci, Martin Luther King and other great historical figures parade across the screen.
The great man in question is none other than Peter Nygrd, the Helsinki-born, Manitoba-raised fashion magnate best known as the founder of Nygrd International.
And his plan to save humanity? Use stem-cell research to cure diseases and live forever, just as you would expect a billionaire tycoon to declare in a Bond movie.
In a 10-minute YouTube video titled Bahamas Stem Cell Laws: The Peter Nygrd Breakthrough, the 70-year-old former Winnipegger claims to be at the forefront of scientific and legislative efforts to further the achievements of stem-cell research.
Nygrd claims to have lobbied the Bahamian government to further stem-cell research, though the Bahamas Weekly reported the island nation's attorney general denied the billionaire was involved in drafting legislation.
That alone is fascinating, but Nygrd isn't just a stem-cell advocate. He says he's personally involved in the research by receiving injections of his own cells grown in Peter, or rather, petri dishes.
Yes, Nygrd claims he is actually getting younger. In his video, he calls stem-cell research a game-changer for humanity.
"This could eliminate all disease. This perhaps is immortality," he breathlessly states in a video that appears entirely serious.
"Ponce de Leon had the right idea. He was just too early," Nygrd continues, referring to the 16th-century conquistador who searched for the fountain of youth. "That was then. This is now."
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Nygrd uses stem cells to pursue immortality
New neurons generated in brains, spinal cords of living adult mammals
By raymumme
UT Southwestern Medical Center researchers created new nerve cells in the brains and spinal cords of living mammals without the need for stem cell transplants to replenish lost cells.
Although the research indicates it may someday be possible to regenerate neurons from the body's own cells to repair traumatic brain injury or spinal cord damage or to treat conditions such as Alzheimer's disease, the researchers stressed that it is too soon to know whether the neurons created in these initial studies resulted in any functional improvements, a goal for future research.
Spinal cord injuries can lead to an irreversible loss of neurons, and along with scarring, can ultimately lead to impaired motor and sensory functions. Scientists are hopeful that regenerating cells can be an avenue to repair damage, but adult spinal cords have limited ability to produce new neurons. Biomedical scientists have transplanted stem cells to replace neurons, but have faced other hurdles, underscoring the need for new methods of replenishing lost cells.
Scientists in UT Southwestern's Department of Molecular Biology first successfully turned astrocytes -- the most common non-neuronal brain cells -- into neurons that formed networks in mice. They now successfully turned scar-forming astrocytes in the spinal cords of adult mice into neurons. The latest findings are published today in Nature Communications and follow previous findings published in Nature Cell Biology.
"Our earlier work was the first to clearly show in vivo (in a living animal) that mature astrocytes can be reprogrammed to become functional neurons without the need of cell transplantation. The current study did something similar in the spine, turning scar-forming astrocytes into progenitor cells called neuroblasts that regenerated into neurons," said Dr. Chun-Li Zhang, assistant professor of molecular biology at UT Southwestern and senior author of both studies.
"Astrocytes are abundant and widely distributed both in the brain and in the spinal cord. In response to injury, these cells proliferate and contribute to scar formation. Once a scar has formed, it seals the injured area and creates a mechanical and biochemical barrier to neural regeneration," Dr. Zhang explained. "Our results indicate that the astrocytes may be ideal targets for in vivo reprogramming."
The scientists' two-step approach first introduces a biological substance that regulates the expression of genes, called a transcription factor, into areas of the brain or spinal cord where that factor is not highly expressed in adult mice. Of 12 transcription factors tested, only SOX2 switched fully differentiated, adult astrocytes to an earlier neuronal precursor, or neuroblast, stage of development, Dr. Zhang said.
In the second step, the researchers gave the mice a drug called valproic acid (VPA) that encouraged the survival of the neuroblasts and their maturation (differentiation) into neurons. VPA has been used to treat epilepsy for more than half a century and also is prescribed to treat bipolar disorder and to prevent migraine headaches, he said.
The current study reports neurogenesis (neuron creation) occurred in the spinal cords of both adult and aged (over one-year old) mice of both sexes, although the response was much weaker in the aged mice, Dr. Zhang said. Researchers now are searching for ways to boost the number and speed of neuron creation. Neuroblasts took four weeks to form and eight weeks to mature into neurons, slower than neurogenesis reported in lab dish experiments, so researchers plan to conduct experiments to determine if the slower pace helps the newly generated neurons properly integrate into their environment.
In the spinal cord study, SOX2-induced mature neurons created from reprogramming of astrocytes persisted for 210 days after the start of the experiment, the longest time the researchers examined, he added.
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New neurons generated in brains, spinal cords of living adult mammals
Researchers Generate New Neurons in Brains, Spinal Cords of Living Adult Mammals Without the Need of Stem Cell …
By JoanneRUSSELL25
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Newswise DALLAS, Feb. 25, 2014 UTSouthwestern Medical Center researchers created new nerve cells in the brains and spinal cords of living mammals without the need for stem cell transplants to replenish lost cells.
Although the research indicates it may someday be possible to regenerate neurons from the bodys own cells to repair traumatic brain injury or spinal cord damage or to treat conditions such as Alzheimers disease, the researchers stressed that it is too soon to know whether the neurons created in these initial studies resulted in any functional improvements, a goal for future research.
Spinal cord injuries can lead to an irreversible loss of neurons, and along with scarring, can ultimately lead to impaired motor and sensory functions. Scientists are hopeful that regenerating cells can be an avenue to repair damage, but adult spinal cords have limited ability to produce new neurons. Biomedical scientists have transplanted stem cells to replace neurons, but have faced other hurdles, underscoring the need for new methods of replenishing lost cells.
Scientists in UTSouthwesterns Department of Molecular Biology first successfully turned astrocytes the most common non-neuronal brain cells into neurons that formed networks in mice. They now successfully turned scar-forming astrocytes in the spinal cords of adult mice into neurons. The latest findings are published today in Nature Communications and follow previous findings published in Nature Cell Biology.
Our earlier work was the first to clearly show in vivo (in a living animal) that mature astrocytes can be reprogrammed to become functional neurons without the need of cell transplantation. The current study did something similar in the spine, turning scar-forming astrocytes into progenitor cells called neuroblasts that regenerated into neurons, said Dr. Chun-Li Zhang, assistant professor of molecular biology at UTSouthwestern and senior author of both studies.
Astrocytes are abundant and widely distributed both in the brain and in the spinal cord. In response to injury, these cells proliferate and contribute to scar formation. Once a scar has formed, it seals the injured area and creates a mechanical and biochemical barrier to neural regeneration, Dr. Zhang explained. Our results indicate that the astrocytes may be ideal targets for in vivo reprogramming.
The scientists' two-step approach first introduces a biological substance that regulates the expression of genes, called a transcription factor, into areas of the brain or spinal cord where that factor is not highly expressed in adult mice. Of 12 transcription factors tested, only SOX2 switched fully differentiated, adult astrocytes to an earlier neuronal precursor, or neuroblast, stage of development, Dr. Zhang said.
In the second step, the researchers gave the mice a drug called valproic acid (VPA) that encouraged the survival of the neuroblasts and their maturation (differentiation) into neurons. VPA has been used to treat epilepsy for more than half a century and also is prescribed to treat bipolar disorder and to prevent migraine headaches, he said.
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Researchers Generate New Neurons in Brains, Spinal Cords of Living Adult Mammals Without the Need of Stem Cell ...
Helping people with spinal cord injuries
By JoanneRUSSELL25
REGINA Meeting Rick Hansen during his Man in Motion world tour sparked six-year-old Josef Buttigiegs fascination with biology and set his career course in motion.
Twenty-eight years after first meeting Hansen, Buttigieg is a biology professor at the University of Regina. Recently he received a $100,000 grant over two years from the Saskatchewan Health Research Foundation (SHRF) to improve the lives of people with spinal cord injuries.
One day Buttigieg hopes hes able to heal his hero.
He vividly recalls hearing Hansen speak at his elementary school in Toronto and talking with him afterwards.
I was really curious about how being in a car accident can result in a spinal cord injury or not being able to walk I just couldnt fathom that, Buttigieg said.
During his first year at McMaster University in Hamilton, Buttigieg again crossed paths with Hansen when he spoke at the university during a ceremony where he received an honorary doctorate.
Further inspired, Buttigieg became a volunteer research student in a spinal cord injury lab at McMaster before pursuing graduate studies there. He went on to work with a prominent neurosurgeon specializing in spinal cord injuries before arriving at the U of R in 2011 and starting his research program.
One of the focuses of Buttigiegs research is stem cell regeneration for spinal cord injuries, stroke and multiple sclerosis.
In terms of the damage to the nervous system, its very similar between the three cases, he said.
When a spinal cord is healthy, a signal is sent from the brain to the nerve, and then the nerve is turned off.
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Helping people with spinal cord injuries