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Newswise A 26-year-old woman paralyzed after a motor vehicle accident a year ago has successfully undergone a first-in-human experimental procedure to test whether neural stem cells injected at the site of a spinal cord injury is safe and could be an effective treatment.

The procedure, conducted on Sept. 30 under the auspices of the Sanford Stem Cell Clinical Center at UC San Diego Health System and in collaboration with Neuralstem, Inc., a Maryland-based biotechnology firm, is the first of four in the Phase I clinical trial. Post safety testing, its hoped that the transplanted neural stem cells will develop into new neurons that bridge the gap created by the injury, replace severed or lost nerve connections and restore at least some motor and sensory function.

The patient, whose identity remains confidential for privacy reasons, has been discharged and is recovering without complication or adverse effects at home, said Joseph Ciacci, MD, principal investigator and neurosurgeon at UC San Diego Health System.

The spinal cord injury trial is one of three recent ground-breaking stem cell efforts at UC San Diego, supported by the Sanford Stem Cell Clinical Center, to make the significant leap from laboratory to first-in-human clinical trials.

Last month, researchers at UC San Diego Moores Cancer Center and the Sanford Stem Cell Clinical Center launched a novel Phase I trial to assess the safety of a monoclonal antibody treatment that targets cancer stem cells in patients with chronic lymphocytic leukemia, the most common form of blood cancer.

And later this month, the first patient is scheduled to receive an unprecedented stem cell-based therapy designed to treat type 1diabetes in another Phase I clinical trial at UC San Diego.

What we are seeing after years of work is the rubber hitting the road, said Lawrence Goldstein, PhD, director of the UC San Diego Stem Cell program and Sanford Stem Cell Clinical Center at UC San Diego Health System. These are three very ambitious and innovative trials. Each followed a different development path; each addresses a very different disease or condition. It speaks to the maturation of stem cell science that weve gotten to the point of testing these very real medical applications in people.

To be sure, Goldstein said, the number of patients involved in these first trials is small. The initial focus is upon treatment with low doses to assess safety, but also with hope of patient benefit. As these trials progress and additional trials are launched Goldstein predicts greater numbers of patients will be enrolled at UC San Diego and the Sanford Stem Cell Clinical Center and elsewhere.

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Promise Put to the Test

A 26-year-old woman paralyzed after a motor vehicle accident a year ago has successfully undergone a first-in-human experimental procedure to test whether neural stem cells injected at the site of a spinal cord injury is safe and could be an effective treatment.

The procedure, conducted on Sept. 30 under the auspices of the Sanford Stem Cell Clinical Center at UC San Diego Health System and in collaboration with Neuralstem, Inc., a Maryland-based biotechnology firm, is the first of four in the Phase I clinical trial. Post safety testing, it's hoped that the transplanted neural stem cells will develop into new neurons that bridge the gap created by the injury, replace severed or lost nerve connections and restore at least some motor and sensory function.

The patient, whose identity remains confidential for privacy reasons, has been discharged and is recovering without complication or adverse effects at home, said Joseph Ciacci, MD, principal investigator and neurosurgeon at UC San Diego Health System.

The spinal cord injury trial is one of three recent ground-breaking stem cell efforts at UC San Diego, supported by the Sanford Stem Cell Clinical Center, to make the significant leap from laboratory to first-in-human clinical trials.

Last month, researchers at UC San Diego Moores Cancer Center and the Sanford Stem Cell Clinical Center launched a novel Phase I trial to assess the safety of a monoclonal antibody treatment that targets cancer stem cells in patients with chronic lymphocytic leukemia, the most common form of blood cancer.

And later this month, the first patient is scheduled to receive an unprecedented stem cell-based therapy designed to treat type 1diabetes in another Phase I clinical trial at UC San Diego.

"What we are seeing after years of work is the rubber hitting the road," said Lawrence Goldstein, PhD, director of the UC San Diego Stem Cell program and Sanford Stem Cell Clinical Center at UC San Diego Health System. "These are three very ambitious and innovative trials. Each followed a different development path; each addresses a very different disease or condition. It speaks to the maturation of stem cell science that we've gotten to the point of testing these very real medical applications in people."

To be sure, Goldstein said, the number of patients involved in these first trials is small. The initial focus is upon treatment with low doses to assess safety, but also with hope of patient benefit. As these trials progress -- and additional trials are launched -- Goldstein predicts greater numbers of patients will be enrolled at UC San Diego and the Sanford Stem Cell Clinical Center and elsewhere.

"Clinical trials are the safest way to pursue potential therapies. You want to prove that a new therapy will work for more than just a single, random patient."

While stem cell-based trials are beginning to emerge around the country, Goldstein noted that San Diego continues to assert itself as a stem cell research hub and a leading force for translating basic discoveries into medical applications, now and in the future.

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With three first-in-human trials, therapeutic stem cell science takes a bold step

Published October 15, 2014

For the first time, researchers have created functioning human lung cells from stem cells.

The longest-running trial of stem cells derived from a human embryo found that the cells caused patients none of the problems scientists feared, such as forming tumors, and reversed partial blindness in about half the eyes receiving transplants, researchers reported on Tuesday.

The results, published in The Lancet, could help re-invigorate the controversial quest to harness stem cells, which have the ability to turn into any of the 200 kinds of human cells, to treat diseases.

In an accompanying commentary, Dr. Anthony Atala of the Wake Forest Institute for Regenerative Medicine called the work "a major accomplishment."

After intense excitement among scientists and the public about the promise of stem cells and ethical debates about destroying human embryos to obtain them, the field stumbled when a high-profile trial for spinal cord injury was halted by Geron Corp in 2011 and the interest of other companies waned.

The small study's main goal was assessing the safety of the transplanted cells. Called retinal pigment epithelial cells, they were created by taking stem cells from a days-old embryo created in a fertility clinic and inducing them to differentiate into the specialized cells.

The study "provides the first evidence, in humans with any disease, of the long-term safety and possible biologic activity" of cells derived from embryos, said co-author Dr. Robert Lanza, chief scientific officer of Advanced Cell Technology, which produced the cells and funded the study.

Nine patients with Stargardt's disease (which causes macular degeneration in childhood) and nine with dry age-related macular degeneration (a leading cause of adult blindness) received implants of the retinal cells in one eye. The other eye served as a control.

Four eyes developed cataracts and two became inflamed, probably due to the patients' age (median: 77) or the use of immune-supressing transplant drugs.

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Stem cells from human embryos prove safe, improve vision, study says

TIME Health medicine Stem Cells Allow Nearly Blind Patients to See Stem cells could lead to new treatments for eye disorders Photography by Peter A. KemmerGetty Images/Flickr RF Embryonic stem cells can be turned into a therapy to help the sight of the nearly blind

In a report published in the journal Lancet, scientists led by Dr. Robert Lanza, chief scientific officer at Advanced Cell Technology, provide the first evidence that stem cells from human embryos can be a safe and effective source of therapies for two types of eye diseasesage-related macular degeneration, the most common cause of vision loss in people over age 60, and Stargardts macular dystrophy, a rarer, inherited condition that can leave patients legally blind and only able to sense hand motions.

In the study, 18 patients with either disorder received transplants of retinal epithelial cells (RPE) made from stem cells that came from human embryos. The embryos were from IVF procedures and donated for research. Lanza and his team devised a process of treating the stem cells so they could turn into the RPE cells. In patients with macular degeneration, these are the cells responsible for their vision loss; normally they help to keep the nerve cells that sense light in the retina healthy and functioning properly, but in those with macular degeneration or Stargardts, they start to deteriorate. Without RPE cells, the nerves then start to die, leading to gradual vision loss.

MORE: Stem Cell Miracle? New Therapies May Cure Chronic Conditions Like Alzheimers

The transplants of RPE cells were injected directly into the space in front of the retina of each patients most damaged eye. The new RPE cells cant force the formation of new nerve cells, but they can help the ones that are still there to keep functioning and doing their job to process light and help the patient to see. Only one RPE can maintain the health of a thousand photoreceptors, says Lanza.

The trial is the only one approved by the Food and Drug Administration involving human embryonic stem cells as a treatment. (Another, the first to gain the agencys approval, involved using human embryonic stem cells to treat spinal cord injury, but was stopped by the company.) Because the stem cells come from unrelated donors, and because they can grow into any of the bodys many cells types, experts have been concerned about their risks, including the possibility of tumors and immune rejection.

MORE: Early Success in a Human Embryonic Stem Cell Trial to Treat Blindness

But Lanza says the retinal space in the eye is the ideal place to test such cells, since the bodys immune cells dont enter this space. Even so, just to be safe, the patients were all given drugs to suppress their immune system for one week before the transplant and for 12 weeks following the surgery.

While the trial was only supposed to evaluate the safety of the therapy, it also provided valuable information about the technologys potential effectiveness. The patients have been followed for more than three years, and half of the 18 were able to read three more lines on the eye chart. That translated to critical improvements in their daily lives as wellsome were able to read their watch and use computers again.

Our goal was to prevent further progression of the disease, not reverse it and see visual improvement, says Lanza. But seeing the improvement in vision was frosting on the cake.

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Stem Cells Allow Nearly Blind Patients to See

After 26 years in a wheel chair William Orr is walking. Granted it is with the assistance of a walker, but he is walking. Orr is walking to get his mail, he is walking to rehab from his parked car and he is planning on walking into his 35th high school reunion. The 52-year-old Aurora man has been a quadriplegic for half his life, since a car hit him while he was riding his bike back in 1986. He suffered a C6-C7 incomplete spinal cord injury and has used a wheel chair since.In August of 2010, Orr underwent what many believe is a first of its kind stem cell procedure in Naples, Florida, using bone marrow from his hip that doctors believe has regenerated damaged cells in his spinal cord. He had such a good response that a second treatment was performed in July 2012. Subsequently, Orr has gained both motor and sensory improvement, as well as having the majority of his muscle spasms dissipate.

There is a remarkable difference. The results for Mr. Orr and others in the treatment group are truly remarkable and have exceeded our expectations said Michael Calcaterra for Intercellular Sciences. Frankly, this is an area that regeneration was thought not to be possible.

I feel like a new person, said Orr. And its only going to get better. He hopes to someday be walking without the walker. Doctors believe that if his quadriceps strength continues to improve as well as his foot lift, then its a real possibility. In the meantime, hes relishing every new sensation, big or small. Its this amazing work ethic and attitude along with the stem cells, his doctor insists, that will help get this man back on his feet again.

UPDATE:

In July 2013, Mr. Orr took his first independent steps in 27 years as his spinal regeneration continues.

About Adult Stem Cells

Stem cells reside in adult bone marrow and fat, as well as other tissues and organs of the body. These cells have a natural ability to repair damaged tissue, however in people with degenerative diseases they are not released and directed enough to fully repair damaged tissue. Adult stem cells can be extracted from many areas of the body, including the bone marrow, fat, and peripheral blood. Since the stem cells come from the patient there is no possibility for rejection or tumor formation, also there is none of the moral issues involving embryonic cells. Stem cells isolated from the bone marrow or fat have the ability to become different cell types (i.e. nerve cells, liver cells, heart cells, and cartilage cells). Studies have also shown that these cells are capable of homing to and repairing damaged tissue. Studies have shown that these stem cells secrete proteins and peptides that stimulate healing of damaged tissue, including heart muscle and spinal cord. Animal studies have shown stem cells to be reparative in spinal cord injury.

About the Procedure

Spinal cord injury patients are treated utilizing stem cells from their own bodies. The procedure involves obtaining 480ml of bone marrow aspirate from the hip bone, this is done under anesthesia so the patient is completely comfortable. The sample is then put through a process that first activates and then concentrates the stem cells. The stem cells are then delivered to the area of spinal injury utilizing a novel method of intra-arterial injection in a vascular angiography suite. This is an outpatient procedure and minimally invasive. The patient is discharged later that day.

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Spinal Cord Injuries | Quadriplegic | Stem Cells | Stem ...

StemCells Inc. ( STEM ) announced that it has commenced a phase II proof-of-concept study, Pathway, which will use the company's proprietary human neural system stem cells (HuCNS-SC) platform for treating patients suffering from cervical spinal cord injury (SCI). The company's phase II trial is titled "Study of Human Central Nervous System (CNS) Stem Cell Transplantation in Cervical Spinal Cord Injury."

The randomized, controlled, single-blind study will evaluate the safety and efficacy of transplanting HuCNS-SC cells into patients with traumatic injury in the cervical region of the spinal cord. The study will evaluate patients for a period of 12 months post-enrollment.

We remind investors that earlier in the year, the company had reported encouraging interim results from a phase I/II thoracic SCI study. StemCells intends to present final data from the phase I/II study in mid-2015.

According to the press release issued by StemCells, nearly 1.3 million people in the U.S. have reported paralysis due to an SCI and about 56% of spinal cord injuries occur in the cervical region. Upon approval, the new treatment will provide significant benefits to patients suffering from cervical SCI considering the present lack of effective treatments.

Meanwhile, StemCells is currently evaluating HuCNS-SC cells for several other indications including dry age-related macular degeneration (AMD), Pelizeaus-Merzbacher disease (PMD) and Alzheimer's disease.

We expect investor focus to remain on pipeline updates.

StemCells currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Emergent BioSolutions, Inc. ( EBS ), Ligand Pharmaceuticals Inc. ( LGND ) and Medivation, Inc. ( MDVN ). All three carry a Zacks Rank #1 (Strong Buy).

STEMCELLS INC (STEM): Get Free Report

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LIGAND PHARMA-B (LGND): Free Stock Analysis Report

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StemCells Starts Phase II Cervical Spinal Cord Injury Study - Analyst Blog

By Amy Adams

Sarah Heilshorn

It is a turbulent and sometimes deadly life for cells injected to heal injuries. The act of being squirted through a thin needle into the site of an injury jostles the delicate cells against each other and against the needle walls. Then, once in the site of injury, they face a biological war zone of chemicals. It's no wonder, then, that treating spinal cord injuries and other damage with injected cells has been a challenge.

Solving this problem takes more than biological know-how; it takes padding chemical padding in the form of complex molecules called polymers that bathe and protect the cells but also flow smoothly through thin needles.

Sarah Heilshorn, an associate professor of materials science and engineering at Stanford, equates these gel-like polymers to ketchup. It's pretty thick, but when you bang on the bottle the sauce flows smoothly through the neck, then firms back up on the plate a process she calls self-healing. "We want our polymers to self-heal better than ketchup," she said. "It flows a bit across the plate."

Her goal is to develop a polymer that supports the cells when they are loaded in a syringe, but then flows freely through the needle, padding and protecting the cells, then firming up quickly when it reaches the site of injury. "We don't want the cells to flow away," she says.

Heilshorn sees this technology as a platform that could be applied to a variety of cell types and injuries. Some polymers need to be firmer to support cells that like a harder environment. Others need to be softer, or contain different biochemical signals.

Neural stem cells, for example, are more likely to mature into nerves if they are in a soft environment. In a stiff environment, they tend to form supportive cells called astrocytes. Picking the right gel is critical to delivering the right kind of cells.

The biochemicals contained within the gel also matter. "We're putting in different biochemical signals that we hope the cells will respond to," Heilshorn said. "We're trying to make a biochemical home for the cells inside that lesion site."

Heilshorn is part of a team made up of Giles Plant, an associate professor of neurosurgery who is a pioneer in cell-based therapies for spinal cord injury, and Andrew Spakowitz, an associate professor of chemical engineering who is an expert in predicting polymer structures. Together, they are among the 22 teams that recently received seed grants from Stanford Bio-X to bring diverse minds to bear on complex biomedical problems.

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Gel-like padding being developed at Stanford could help cells survive injection, heal spinal cord injuries

Back in 2006, when controversy over embryonic stem cell funding was still raging, a piece of research came along that would make the debate essentially obsolete: normal adult cells can actually be reprogrammed into stem cells. No embryos necessary. The technique went on to win its inventor the Nobel Prize. And now, after many years in the lab, a Japanese patient will the first person to receive the next-gen treatment, called induced pluripotent stem cells.

This first clinical trial for iPSCs has long been in the making. Part of its complexity is that cells are taken from each patient and then, through a series of lab procedures, transformed into stem cells. Each patient gets his or her own genetically matched iPSCs.

This individualization is a key advantage over embryonic stem cells, which have been tested in humans before. Special drugs are required to prevent patients' bodies from rejecting embryonic stem cells.

After some final safety checks and genetic tests, the first clinical trial is officially underway in Japan. Nature reports that the first patient will likely receive iPSCs within days. In total, the clinical trial has enrolled six patients, all of whom with an eye condition called macular degeneration that leads to blindness. The iPSCs will replace a deteriorated layer of cells in their retinas.

So far, the procedure has worked without serious adverse effects (usually tumors) in mice and monkeys. If it works in humans, iPSCs could be a promising new avenue for human stem cell therapy, which, if you remember, could hold the key to all sorts of incurable conditions from diabetes to Parkinson's to spinal cord injuries. This is a small first step in that direction. [Nature]

Top image: an eye with signs of macular degeneration. National Eye Institute

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Induced Stem Cells Will Be Tested on Humans for the First Time

Wichita, KS (PRWEB) September 10, 2014

Ryan Benton, a 28 year-old Duchennes muscular dystrophy patient from Wichita, Kansas, received his first umbilical cord tissue-derived mesenchymal stem cell treatment yesterday following US FDA approval of his doctors application for a single patient, investigational new drug (IND) for compassionate use.

Duchenne muscular dystrophy (DMD) is a rapidly progressive form of muscular dystrophy that occurs primarily in boys. It is caused by an alteration (mutation) in a gene, called the DMD gene, which causes the muscles to stop producing the protein dystrophin. Individuals who have DMD experience progressive loss of muscle function and weakness, which begins in the lower limbs and leads to progressively worsening disability. Death usually occurs by age 25, typically from lung disorders. There is no known cure for DMD.

This trial, officially entitled Allogeneic transplantation of human umbilical cord mesenchymal stem cells (UC-MSC) for a single male patient with Duchenne Muscular Dystrophy (DMD) marks the first time the FDA has approved an investigational allogeneic stem cell treatment for Duchennes in the United States.

Ryan received his first intramuscular stem cell injections from allergy and immunology specialist, Van Strickland, M.D at Asthma and Allergy Specialists in Wichita, Kansas. He will receive 3 more treatments this week on consecutive days. Dr. Strickland will administer similar courses to Ryan every 6 months for a total of 3 years.

This is not the first time Ryan has undergone umbilical cord mesenchymal stem cell therapy. Since 2009, Ryan has been traveling to the Stem Cell Institute in Panama for similar treatments. Encouraging results from these treatments prompted Dr. Strickland to seek out a way to treat Ryan in the United States.

The stem cell technology being utilized in this trial was developed by renowned stem cell scientist Neil H. Riordan, PhD. Dr. Riordan is the founder and president of the Stem Cell Institute in Panama City, Panama and Medistem Panama. Medistem Panama is providing cell harvesting and banking services for their US-based cGMP laboratory partner.

Funding for this trial is being provided by the Aidan Foundation, a non-profit organization founded by Dr. Riordan in 2004 to provide financial assistance for alternative therapies to people like Ryan.

About Van Strickland, MD

Dr. Strickland came to Wichita in 1979 from his fellowship at the National Jewish Hospital in Denver. Since then he has spent one year in Wyoming, one year in Dallas, Texas and one year in Lees Summit Missouri before returning to full-time practice in Wichita, Kansas.

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After FDA Approval, Duchennes Muscular Dystrophy Patient Receives First Umbilical Cord Stem Cell Treatment in the ...

Spinal Cord Injury

Damage to the spinal cord usually results in impairments or loss of muscle movement, muscle control, sensation and body system control.

Presently, post-accident care for those who suffer spinal cord injuries focuses on extensive physical therapy, occupational therapy, and other rehabilitation therapies; teaching the injured person how to cope with their disability.

A number of published papers and case studies support the feasibility of treating spinal cord injury with allogeneic human umbilical cord tissue-derived stem cells and autologous bone marrow-derived stem cells.

Feasibility of combination allogeneic stem cell therapy for spinal cord injury: a case report co-authored by Stem Cell Institute Founder Dr. Neil Riordan references many of them. Published improvements include improved ASIA scores, improved bladder and/or bowel function, recovered sexual function, and increased muscle control.

The adult stem cells used in spinal cord injury investigational treatments at the Stem Cell Institute come from two sources: the subjects own bone marrow (autologous mesenchymal and CD34+) and human umbilical cord tissue (allogeneic mesenchymal).

A licensed anesthesiologist harvests bone marrow from both hips under light general anesthesia in a hospital operating room. This procedure takes about 1 1/2 2 hours. Before they are administered to the subject, these bone marrow-derived stem cells must pass testing for quality, bacterial contamination (aerobic and anaerobic) and endotoxin.

All donated umbilical cords are screened for viruses and bacteria to International Blood Bank Standards.

Our stem cell clinical protocol for spinal cord injury calls for a total of 16 injections over the course of 4 weeks.

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Stem Cell Therapy || Spinal Cord Injury || Investigational ...

Scientific publications from PubMed.gov

PubMed comprises more than 23 million citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full-text content from PubMed Central and publisher web sites.

Regen Med. 2013 May;8(3):271-81 Authors: Ning G, Tang L, Wu Q, Li Y, Li Y, Zhang C, Feng S

Abstract AIM: We aim to explore the repair mechanism after the transplantation of CD34(+) human umbilical cord blood cells (HUCBCs) in traumatic spinal cord injury (SCI) in rats.

MATERIALS & METHODS: Wistar rats with SCI were randomly divided into three groups: DMEM injection (group A); CD34(+) HUCBC transplantation on the first day after injury (group B); and CD34(+) HUCBC transplantation on the sixth day after injury (group C). The Basso, Beattie and Bresnahan scores were used to evaluate motor behavior. At the injured site, the infarct size, blood vessel density, and survival and neural differentiation of transplanted cells were analyzed.

RESULTS: It was found that the Basso, Beattie and Bresnahan score in group B was significantly higher than other groups (p < 0.05), and the infarct size and blood vessel density at the injured site were significantly different (p < 0.01). However, the transplanted cells survived at least 3 weeks at the injured site, but did not differentiate into neural cells.

CONCLUSION: These results suggested transplantation of CD34(+) HUCBCs during the acute phase could promote the functional recovery better than during the subacute phase after SCI by raising blood vessel density, suggesting the possible clinical application for the treatment of spinal injury.

PMID: 23627822 [PubMed - indexed for MEDLINE]

Cytotherapy. 2013 Feb;15(2):185-91 Authors: Liu J, Han D, Wang Z, Xue M, Zhu L, Yan H, Zheng X, Guo Z, Wang H

Abstract BACKGROUND AIMS: The purpose of this study was to observe the clinical effect and safety of umbilical cord mesenchymal stem cells (UC-MSCs) in treating spinal cord injury (SCI) by intrathecal injection.

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Spinal cord injury and stem cell publications

By RTT News, August 27, 2014, 06:53:00 AM EDT

(RTTNews.com) - Asterias Biotherapeutics Inc. (ASTY.OB) said Wednesday that it has received clearance from the U.S. Food and Drug Administration or FDA to initiate a Phase 1/2a clinical trial of its product, AST-OPC1, in patients with complete cervical spinal cord injury.

The company stated that the approved trial follows the successful completion of the Phase 1 clinical study of the product, and is designed to assess safety and activity of escalating doses of AST-OPC1 in patients with complete cervical spinal cord injuries, the first targeted indication for AST-OPC1 and the first of future product registration clinical trials.

AST-OPC1 is a population of cells derived from human embryonic stem cells (hESCs) that contains oligodendrocyte progenitor cells (OPCs). OPCs and oligodendrocytes perform supportive functions for nerve cells in the central nervous system. The foundation for this newly cleared Phase 1/2a clinical trial comes from results from the Phase 1 clinical trial of AST-OPC1, which met its primary endpoints of safety and feasibility when administered to five patients with neurologically-complete, thoracic spinal cord injury.

These five patients were administered a low dose of two million AST-OPC1 cells and have been followed to date for 2 to 3 years. No serious adverse events were observed associated with the delivery of the cells, the cells themselves, or the short-course immunosuppression regimen used.

The company noted that the new Phase 1/2a clinical trial will be an open-label, single-arm study testing three escalating doses of AST-OPC1 in 13 patients with subacute, C5-C7, neurologically-complete cervical spinal cord injury. These individuals have essentially lost all sensation and movement below their injury site with severe paralysis of the upper and lower limbs.

AST-OPC1 will be administered 14 to 30 days post-injury. Patients will be followed by neurological exams to assess the safety and activity of the product. Selection of the clinical trial sites is well underway and the Company expects to begin patient enrollment during the first quarter of 2015.

The new clinical trial differs from the original clinical study in that doses up to 10 times higher will be tested. In addition, the trial will focus on patients with neurologically-complete cervical spinal cord injuries. Because of the anatomy of the spinal cord and the existence of more sensitive outcomes measures to assess movement of the arms and hands, it is currently believed that detection of efficacy is much more likely to occur in patients with cervical injuries. It is this patient population that Asterias anticipates will be the target for the first registration clinical trials of AST-OPC1.

The results of the Phase 1/2a clinical trial are expected to provide support for a Phase 2b expansion study that will be conducted to more thoroughly demonstrate safety and efficacy of the product.

For comments and feedback: contact editorial@rttnews.com

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Asterias Gets FDA Clearance To Initiate Phase 1/2a Trial Of AST-OPC1

Manila:

A Philippine Catholic bishop Wednesday urged donors to research on Lou Gehrigs Disease to ensure that their money does not go to unethical studies involving stem cells.

The pastoral guidance was issued as more Filipinos take part in the viral fundraising ice bucket challenge for Lou Gehrigs Disease or Amyotrophic Lateral Sclerosis (ALS), a degenerative disease that affects nerve cells in the brain and spinal cord.

Archbishop Socrates Villegas said donors must make a clear and unequivocal declaration that their donation is made on condition that none of it is applied to research that involves the use of embryonic stem cells in vitro. Catholics who participate in the challenge and who make donations to this research must also demand of fund-raisers and organizers an assurance that none of the donations made will be applied to researches that are ethically reproved, he added.

Villegas said that as long as the research was ethical, the Church would even encourage Catholics to donate, noting, The importance of ALS research cannot be overstated. Research must proceed, for so many suffer. Several top government officials, business leaders and other Filipino personalities have recently taken up the ALS ice bucket challenge, drenching themselves in cold water to raise money for research on the illness.

(This article was published on August 27, 2014)

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Filipino bishop urges donors not to support stem cell research

Last week I discussed the current state of stem cell research and the sociopolitical situation surrounding it. As with any controversial or complex subject being shared with the neophyte it is pointless without a physical, material context to put it in. Many people simply don't know something because it doesn't pertain to them. No-one wants to think about disease, let alone talk about it... why in the world would anyone want to research it? I learned very early on in my injury not to hold others accountable for what they do not fully understand. So much of suffering is purely subjective and experiential, how could they possible grasp what I'M feeling? Or vice versa for that matter? That said, ask yourself, why else would I study any kind of infirmity unless I a. had it, or b. was a doctor? This posting will be to inform those of you who do not understand how spinal cord injury happens and the results it can have. It should help you get a stronger grasp on why stem cells are such an interesting possibility.

Spinal cord injury is one of the least understood conditions on the planet. There are approximately 450,000 spinal cord injury survivors in the United States. Compare that to the millions of cancer patients or those with heart disease. It is simply rare. Every spinal cord injury is different, like a finger print. There are thousands of nerves in the spinal cord, one can be damaged or all of them, or none at all. Consider for a moment what the spinal cord is, in the words of Wikipedia...

It gets even more complicated still. There are levels of spinal cord injury. The vertebrae of the spine which becomes injured determines the type or "level" of injury. The cervical spine down to the upper thoracic is classified as Quadriplegia or Tetraplegia the lower you go. Once the injury drops below the third or fourth thoracic vertebrae it becomes Paraplegia.

Clearly we can now see how treating spinal cord injury generally must be done on a case by case basis. When you factor in age, weight, age of injury, lifestyle and amount of therapy it becomes even more complex. Up until now the real treatment has been in progressive physical therapy. The best centers are those who focus solely on rehabilitating injuries to the central nervous system. We can narrow that category down further to those who are committed to continuous movement towards a cure and taking your treatment into your own hands. These facilities are spread throughout the country on such a minimal level many patients devote their entire lives to the cycle of raising money and traveling just for a few days a month, or even a year, to get the level of care they need. Keep in mind the insurance companies will rarely cover even the cost of therapy, let alone travel.

Things are changing however. There is a grassroots movement in medicine that holds exciting promise. I am going to wrap up this portion of the discussion, but next week I'll continue with more on this movement on the horizon, what living with SCI is like and why there is hope in stem cells. Tune in...

More here:
The Stem Cell: Understanding Spinal Cord Injury: Part 1

Stem Cells and Spinal Cord Injury:

Spinal cord injuries are described at various levels of "incomplete", which can vary from having no effect on the patient to a "complete" injury which means a total loss of function.

Treatment of spinal cord injuries starts with restraining the spine and controlling inflammation to prevent further damage. The actual treatment can vary widely depending on the location and extent of the injury. In many cases, spinal cord injuries require substantial physical therapy and rehabilitation, especially if the patient's injury interferes with activities of daily life.

After a spinal cord injury, many of the nerve fibers at the injury site lose their insulating layer of myelin. As a result, the fibers are no longer able to properly transmit signals between the brain and the spinal cord contributing to paralysis. Unfortunately, the spinal cord lacks the ability to restore these lost myelin-forming cells after trauma.

Tissue engineering in the spinal cord involves the implantation of scaffold material to guide cell placement and foster cell development. These scaffolds can also be used to deliver stem cells at the site of injury and maximize their regenerative potential.

When the spinal cord is damagedeither accidentally (car accidents, falls) or as the result of a disease (multiple sclerosis, infections, tumors, severe forms of spinal bifida, etc.)it can result in the loss of sensation and mobility and even in complete paralysis.

Spinal Cord Injury and Stem Cell Treatment

Adult stem cell transplants for spinal cord injury repair: current state in preclinical research.

Hernndeza J, Torres-Espna A, Navarro X.

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Spinal Cord Injury Stem Cell Treatment - ASCI - Stem Cell ...

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Researchers from Rochester, N.Y., and Colorado have revealed that manipulating stem cells prior to transplantation may lead to improved spinal cord repair methods. When nerve fibers are injured in the spinal cord, the severed ends of the nerve fibers fail to regenerate and reconnect with the nervous system circuitry beyond the site of the injury. During early development, the astrocytes cells of the brain and spine are highly supportive of nerve fiber growth, and scientists believe that if properly directed, these cells could play a key role in regenerating damaged nerves in the spinal cord. Rather than transplanting naive stem cells, the team has adopted an approach of pre-differentiating stem cells into better-defined populations of these brain cells. These stem cells are then selected for their ability to promote recovery.

Researchers from Rochester, N.Y., and Colorado have revealed that manipulating stem cells prior to transplantation may lead to improved spinal cord repair methods. When nerve fibers are injured in the spinal cord, the severed ends of the nerve fibers fail to regenerate and reconnect with the nervous system circuitry beyond the site of the injury. During early development, the astrocytes cells of the brain and spine are highly supportive of nerve fiber growth, and scientists believe that if properly directed, these cells could play a key role in regenerating damaged nerves in the spinal cord. Rather than transplanting naive stem cells, the team has adopted an approach of pre-differentiating stem cells into better-defined populations of these brain cells. These stem cells are then selected for their ability to promote recovery.

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Stem Cell Breakthrough in Spinal Cord Injury Repair

Because the ALS Association supports stem-cell research.

The Ice Bucket Challenge has been the biggest viral-charity sensation of the year, and maybe ever reaching its cold, wet arms all the way to George W. Bush and Anna Wintour, and raising millions of dollars for ALS research along with providing an immaculate blooper reel.

But one group is not pleased by all your Facebook videos: anti-abortion activists, who are mad that the ALS Association gives money to a group that supports stem-cell research.

"Attention pro-lifers: be careful where you send your ALS Ice Bucket Challenge donation," blared a headline on LifeNews.com earlier this week. The article explained that the ALS Association, one of the charities receiving ice-bucket donations, gave $500,000 last year to the Northeast ALS Consortium, which in turn had been affiliated with a clinical trial that used "stem cells ... engineered from the spinal cord of a single fetus electively aborted after eight weeks of gestation. The tissue was obtained with the mothers consent."

"Of course the fetus, from whom the 'tissue' was taken, did not 'give consent,'" LifeNews.com wrote. "So if you give to the ALS Association your money may end up supporting clinical trials that use aborted fetal cells."

Following the report, the Cincinnati Archdiocese warned Catholic school principals not to send donations to the ALS Association, andsome anti-abortion activists have begun making their own "pro-life Ice Bucket Challenge" videos.

CBN News, the Christian TV channel that broadcasts Pat Robertson's 700 Club, put a video of its Ice Bucket Challenge on Facebook, but not without informing its audience that the donations from the challenge would go to "an organization that does not support or use embryonic stem cell research."

Meanwhile, a 2013 FDA-approved study using human stem cells resulted in slowing the progression of ALS to an "extraordinary" degree.

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Anti-Abortion Activists Are Doing Their Own Ice Bucket Challenges

The UC San Diego Health System put out a call Monday for eight spinal cord injury patients to take part in a five-year test of the safety of a new treatment involving neural stem cells.

The researchers are looking for people who suffered an injury to the middle or lower levels of the spine's thoracic vertebrae between one and two years ago. According to UCSD, the injury must be between the seventh and 12th thoracic vertebrae.

"The goal of this study is to evaluate the safety of transplanting neural stem cells into the spine for what one day could be a treatment for spinal cord injuries," said Dr. Joseph Ciacci, the study's principal investigator and a neurosurgeon at UC San Diego Health System. "The study's immediate goal, however, is to determine whether injecting these neural stem cells into the spine of patients with spinal cord injury is safe."

The doctors also want to know how long the transplanted stem cells will last, and whether drugs designed to prevent rejection by the immune system are effective, according to UCSD Health.

The researchers will also look for possible changes in motor and sensory function, bowel and bladder function, and pain levels.

The stem cells were tested in laboratory rats by Ciacci and Dr. Martin Marsala, of the UC San Diego School of Medicine. They detected signs of improved motor function with minimal side effects. The cells have also been tested for safety in human patients with amyotrophic lateral sclerosis commonly known as ALS or Lou Gehrig's Disease.

UCSD cautioned prospective test subjects that since human tests are just beginning, unforeseen risks, complications or unpredictable outcomes are possible.

The clinical trial at UC San Diego Health System is funded by Neuralstem Inc. and was launched and supported by the UC San Diego Sanford Stem Cell Clinical Center. The center was recently created to "advance leading-edge stem cell medicine and science, protect and counsel patients, and accelerate innovative stem cell research into patient diagnostics and therapy," according to UCSD.

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UCSD Looking For Spinal Cord Injury Patients To Test Stem Cell Treatment

SAN DIEGO (CNS) - The UC San Diego Health System put out a call Monday for eight spinal cord injury patients to take part in a five-year test of the safety of a new treatment involving neural stem cells.

The researchers are looking for people who suffered an injury to the middle or lower levels of the spine's thoracic vertebrae between one and two years ago. According to UCSD, the injury must be between the seventh and 12th thoracic vertebrae.

"The goal of this study is to evaluate the safety of transplanting neural stem cells into the spine for what one day could be a treatment for spinal cord injuries," said Dr. Joseph Ciacci, the study's principal investigator and a neurosurgeon at UC San Diego Health System. "The study's immediate goal, however, is to determine whether injecting these neural stem cells into the spine of patients with spinal cord injury is safe."

The doctors also want to know how long the transplanted stem cells will last, and whether drugs designed to prevent rejection by the immune system are effective, according to UCSD Health.

The researchers will also look for possible changes in motor and sensory function, bowel and bladder function, and pain levels.

The stem cells were tested in laboratory rats by Ciacci and Dr. Martin Marsala, of the UC San Diego School of Medicine. They detected signs of improved motor function with minimal side effects. The cells have also been tested for safety in human patients with amyotrophic lateral sclerosis - commonly known as ALS or Lou Gehrig's Disease.

UCSD cautioned prospective test subjects that since human tests are just beginning, unforeseen risks, complications or unpredictable outcomes are possible.

The clinical trial at UC San Diego Health System is funded by Neuralstem Inc. and was launched and supported by the UC San Diego Sanford Stem Cell Clinical Center. The center was recently created to "advance leading-edge stem cell medicine and science, protect and counsel patients, and accelerate innovative stem cell research into patient diagnostics and therapy," according to UCSD.

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UCSD test calls for spinal cord injury patients

SAN DIEGO The UC San Diego Health System put out a call Monday for eight spinal cord injury patients to take part in a five-year test of the safety of a new treatment involving neural stem cells.

The researchers are looking for people who suffered an injury to the middle or lower levels of the spines thoracic vertebrae between one and two years ago. According to UCSD, the injury must be between the seventh and 12th thoracic vertebrae.

The goal of this study is to evaluate the safety of transplanting neural stem cells into the spine for what one day could be a treatment for spinal cord injuries, said Dr. Joseph Ciacci, the studys principal investigator and a neurosurgeon at UC San Diego Health System. The studys immediate goal, however, is to determine whetherinjecting these neural stem cells into the spine of patients with spinal cord injury is safe.

The doctors also want to know how long the transplanted stem cells will last, and whether drugs designed to prevent rejection by the immune system are effective, according to UCSD Health.

The researchers will also look for possible changes in motor and sensory function, bowel and bladder function, and pain levels.

The stem cells were tested in laboratory rats by Ciacci and Dr. Martin Marsala, of the UC San Diego School of Medicine. They detected signs of improved motor function with minimal side effects. The cells have also been tested for safety in human patients with amyotrophic lateral sclerosis commonly known as ALS or Lou Gehrigs Disease.

UCSD cautioned prospective test subjects that since human tests are just beginning, unforeseen risks, complications or unpredictable outcomes are possible.

The clinical trial at UC San Diego Health System is funded by Neuralstem Inc. and was launched and supported by the UC San Diego Sanford Stem Cell Clinical Center. The center was recently created to advance leading-edge stem cell medicine and science, protect and counsel patients, and accelerate innovative stem cell research into patient diagnostics and therapy, according to UCSD.

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Spinal injury patients needed for stem cell treatment study