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NIH stem-cell programme closes

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Bradley J. Fikes

Stem-cell biologist Mahendra Rao expected five projects to receive support to set up clinical trials.

Stem-cell researchers at the US National Institutes of Health (NIH) have been left frustrated and confused following the demise of the agencys Center for Regenerative Medicine (CRM). The intramural programmes director, stem-cell biologist Mahendra Rao, left the NIH, in Bethesda, Maryland, on 28March, and the centres website was taken down on 4 April. Although no official announcement had been made at the time Nature went to press, NIH officials say that they are rethinking how they will conduct in-house stem-cell research.

Researchers affiliated with the centre say that they have been left in the dark. When contacted by Nature on 7April, George Daley, a stem-cell biologist at Harvard Medical School in Boston, Massachusetts, and a member of the centres external advisory board, said that he had not yet been told of Raos departure or the centres closure.

The CRM was established in 2010 to centralize the NIHs stem-cell programme. Its goal was to develop useful therapies from induced pluripotent stem (iPS) cells adult cells that have been converted into embryonic-like stem cells and shepherd them towards clinical trials and regulatory approval. Its budget was intended to be $52million over seven years.

Rao took the helm in 2011. Relations seem to have soured last month owing to an NIH decision to award funding to only one project aiming to move iPS cells into a clinical trial. Rao says he resigned after this became clear. He says that he had hoped that five trials would be funded, especially because the centre had already sorted out complex issues relating to tissue sources, patents and informed consent.

James Anderson, director of the NIHs Division of Program Coordination, Planning, and Strategic Initiatives, which administered the CRM, counters that only one application that made by Kapil Bharti of the National Eye Institute in Bethesda and his colleagues received a high enough score from an external review board to justify continued funding. The team aims to use iPS cells to treat age-related macular degeneration of the retina, and hopes to commence human trials within a few years. Several other proposals, which involved the treatment of cardiac disease, cancer and Parkinsons disease, will not receive funding to ready them for clinical trials. Anderson stresses that Bhartis trial will not be affected by the CRMs closure.

NIH

Therapies based on induced pluripotent stem cells, here differentiating into retinal cells on a scaffold, were the focus of the Center for Regenerative Medicine.

Other human iPS-cell trials are further along. For example, one on macular degeneration designed by Masayo Takahashi at the RIKEN Center for Developmental Biology in Kobe, Japan, began recruiting patients last August.

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NIH stem-cell programme closes

Stem Cells Show Promise for Stroke Recovery

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Brenda Goodman HealthDay Reporter Posted: Monday, April 7, 2014, 4:00 PM

MONDAY, April 7, 2014 (HealthDay News) -- In an early test, researchers report they've safely injected stem cells into the brains of 18 patients who had suffered strokes. And two of the patients showed significant improvement.

All the patients saw some improvement in weakness or paralysis within six months of their procedures. Although three people developed complications related to the surgery, they all recovered. There were no adverse reactions to the transplanted stem cells themselves, the study authors said.

What's more, the researchers said, two patients experienced dramatic recoveries almost immediately after the treatments.

Those patients, who were both women, started to regain the ability to talk and walk the morning after their operations. In both cases, they were more than two years past their strokes, a point where doctors wouldn't have expected further recovery.

The results have encouraged researchers to plan larger and longer tests of the procedure, which uses stem cells cultured from donated bone marrow.

An expert who was not involved in the research called it a promising first step.

"It's a small, early human study. It takes multiple steps to get to something clinically useful, and this is a nice, early step," said Dr. Steven Cramer, clinical director of the Stem Cell Research Center at the University of California, Irvine.

The findings were to be presented Monday at the American Association of Neurological Surgeons annual meeting, in San Francisco. The results of studies presented at meetings are considered preliminary until they've been published in peer-reviewed medical journals.

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Stem Cells Show Promise for Stroke Recovery

Transplantation Cell Therapy Offers Hope to Stroke Patients

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Newswise SAN FRANCISCO (April 7, 2014) The devastating effects of stroke have long led physicians to conclude that lost brain function is irreversible. Today during the 82nd Annual Scientific Meeting of the American Association of Neurological Surgeons (AANS), researchers presented the results of a groundbreaking study that offers new hope to stroke patients.

In the first North American trial of its kind, researchers conducted intraparenchymal transplantation of bone marrow-derived cell therapy in chronic stroke patients. Titled A Novel Phase 1/2A Study of Intraparenchymal Transplantation of Human Modified Bone Marrow Derived Cells in Patients with Stable Ischemic Stroke, the study tested the feasibility of administering escalated doses of stromal cells. Numerous preclinical animal stroke studies showing the benefit of stem cell transplantation led to the initiation of this clinical trial.

The study was led by Gary K. Steinberg, MD, PhD, FAANS: Although this was primarily a safety study, we found a significant recovery of neurologic function in patients overall at six months that is sustained at one year. Two of the 18 transplanted patients showed remarkable improvement.

Transplanted patients continued to recover substantial neurologic function two years or more following their stroke, said Dr. Steinberg: This suggests that the affected neural circuits following stroke are not dead, but potentially still viable and can be reactivated, which is contrary to the currently accepted dogma.

The clinical findings have led to new studies using brain stimulation of circuits to restore neurologic function in animal stroke models.

Study co-authors are Douglas Kondziolka, MD, FAANS; Neil Schwartz, MD, PhD; Lawrence Wechsler, MD; Dade Lunsford, MD, FAANS; Maria Coburn, BA; Julia Billigen, RN; Hadar Keren-Gill, BS; Michael McGrogan, PhD; Casey Case, PhD; Kelta Mori, MBA; and Ernest Yankee, PhD.

Disclosure: The author reported the following disclosures prior to the 82nd AANS Annual Scientific Meeting: NIH NINDS; California Institute for Regenerative Medicine; Medtronic.

Media Representatives: The 2014 AANS Annual Meeting Press Kit includes releases on highlighted scientific research, AANS officer and award winners, National Neurosurgery Awareness Week, and other relevant information about this years program. Those releases also will be posted under the Media area on the 2014 AANS Annual Scientific Meeting website (http://www.aans.org/Annual Meeting/2014/Main/Media.aspx). If you would have interest in a topic related to neurosurgery or would like to interview a neurosurgeon either onsite or via telephone during this years event, please contact John Iwanski, AANS Director of Integrated Marketing and Website Communications, via the onsite press room at 415.978.3603 or e-mail him at jai@aans.org.

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Transplantation Cell Therapy Offers Hope to Stroke Patients

VIDEO | Ateneo graduate dies after undergoing stem cell therapy

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By: Ina Zara, News5 April 7, 2014 9:05 PM

Contributed file photo of Katherine Grace Tan.

InterAksyon.com The online news portal of TV5

MANILA, Philippines A cum laude graduate from the Ateneo de Manila University, who was suffering from Hodgkin's lymphoma, died last year after undergoing embryonic stem cell therapy that was allegedly administered by Antonia Park, the alternative medicine doctor of former President Gloria Macapagal-Arroyo.

Bernard Tan claimed that Park had promised that within three months, his 23-year-old daughter, Katherine Grace Tan, would be cured of her disease, which according to the doctor was not cancer but just hormonal imbalance.

But after undergoing treatment and strictly following a juice diet, Katherine got weaker and died.

Earlier this month, it was reported that Park, of the Green & Young Health & Wellness Center,admitted that she wasnt licensed to practice in the Philippines.

Records from the theProfessional Regulatory Commission as of August 2013 showed that Park was not on the list of physicians authorized to practice medicine in the country.

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VIDEO | Ateneo graduate dies after undergoing stem cell therapy

FDA Approves CardioCell’s Phase 2A Trial For CHF Stem Cell Therapy

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By Estel Grace Masangkay

CardioCell LLC announced that it has received FDA approval for its investigational new drug (IND) application for a U.S.-based Phase IIA clinical study evaluating its allogeneic stem-cell therapy for patients with chronic heart failure (CHF).

Dr. Sergey Sikora, CardioCells president and CEO, said, With the FDAs IND approval, CardioCell is pleased to proceed with a Phase 2a CHF clinical trial based on the safety data reported in previous clinical trials using our unique, hypoxically grown stem cells. At the studys conclusion we will understand if our therapy produces signs of improvement in a population of patients with dilated CHF, a condition largely unaddressed by current therapies. Dilated CHF is characterized by a viable but non-functioning myocardium in which cardiomyocytes are alive but are not contracting as they should. We hope that unique properties of our itMSCs will transition patients cardiomyocytes from viable to functioning, eventually improving or restoring heart function.

The company has developed an ischemic tolerant mesenchymal stem cells (itMSC) treatment for the type of dilated CHF that is not related to coronary artery disease. The treatment could potentially apply to about 35 percent of CHF patients. Only CardioCells CHF therapies feature itMSCs, exclusively licensed from CardioCells parent company Stemedica Cell Technologies Inc. The company said Stemedicas bone marrow-derived, allogeneic MSCs are different from other MSCs because they are grown under hypoxic conditions that closely resemble the environment in which they thrive on in the body.

Dr. Stephen Epstein, CardioCells Scientific Advisory Board Chair, said Although past trials have tested the efficacy of different stem cells in patients with DCM, CardioCells itMSCs, grown under chronic hypoxic conditions, are unique. As compared to stem cells grown under normoxic conditions, they express higher levels of factors that could exert beneficial effects on the mechanisms contributing to myocardial dysfunction and disease progression. This study, therefore, provides an exciting opportunity to test the potential of these itMSCs to attenuate or eliminate these mechanisms and, in so doing, improve patient outcomes.

The trial entitled A Phase 2a, Single-Blind, Placebo-Controlled, Crossover, Multi-Center, Randomized Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Ischemia-Tolerant Allogeneic Mesenchymal Bone Marrow Cells to Subjects With Heart Failure of Non-Ischemic Etiology, will be conducted at Emory University, Northwestern University, and the University of Pennsylvania in May this year.

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FDA Approves CardioCell's Phase 2A Trial For CHF Stem Cell Therapy

FDA Approves CardioCell's Phase 2A Trial For CHF Stem Cell Therapy

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By Estel Grace Masangkay

CardioCell LLC announced that it has received FDA approval for its investigational new drug (IND) application for a U.S.-based Phase IIA clinical study evaluating its allogeneic stem-cell therapy for patients with chronic heart failure (CHF).

Dr. Sergey Sikora, CardioCells president and CEO, said, With the FDAs IND approval, CardioCell is pleased to proceed with a Phase 2a CHF clinical trial based on the safety data reported in previous clinical trials using our unique, hypoxically grown stem cells. At the studys conclusion we will understand if our therapy produces signs of improvement in a population of patients with dilated CHF, a condition largely unaddressed by current therapies. Dilated CHF is characterized by a viable but non-functioning myocardium in which cardiomyocytes are alive but are not contracting as they should. We hope that unique properties of our itMSCs will transition patients cardiomyocytes from viable to functioning, eventually improving or restoring heart function.

The company has developed an ischemic tolerant mesenchymal stem cells (itMSC) treatment for the type of dilated CHF that is not related to coronary artery disease. The treatment could potentially apply to about 35 percent of CHF patients. Only CardioCells CHF therapies feature itMSCs, exclusively licensed from CardioCells parent company Stemedica Cell Technologies Inc. The company said Stemedicas bone marrow-derived, allogeneic MSCs are different from other MSCs because they are grown under hypoxic conditions that closely resemble the environment in which they thrive on in the body.

Dr. Stephen Epstein, CardioCells Scientific Advisory Board Chair, said Although past trials have tested the efficacy of different stem cells in patients with DCM, CardioCells itMSCs, grown under chronic hypoxic conditions, are unique. As compared to stem cells grown under normoxic conditions, they express higher levels of factors that could exert beneficial effects on the mechanisms contributing to myocardial dysfunction and disease progression. This study, therefore, provides an exciting opportunity to test the potential of these itMSCs to attenuate or eliminate these mechanisms and, in so doing, improve patient outcomes.

The trial entitled A Phase 2a, Single-Blind, Placebo-Controlled, Crossover, Multi-Center, Randomized Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Ischemia-Tolerant Allogeneic Mesenchymal Bone Marrow Cells to Subjects With Heart Failure of Non-Ischemic Etiology, will be conducted at Emory University, Northwestern University, and the University of Pennsylvania in May this year.

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FDA Approves CardioCell's Phase 2A Trial For CHF Stem Cell Therapy

Umbilical Cord Stem Cell Therapy Clinical Trial for Multiple Sclerosis Gets Green Light

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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

New York Podiatrist Dr. Jeffrey Adler to Be Interviewed April 5 on NewsTalkRadio 77 WABC About the Use of Stem Cell …

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New York, New York (PRWEB) April 03, 2014

Dr. Jeffrey Adler, New York podiatrist and Owner/Medical Director of Adler Footcare New York, will be interviewed by radio personality Laura Smith and taking live calls on New York talk show 77 WABC about the use of stem cells to treat chronic foot pain.

Adler Footcare New York uses live birth stem cells to help treat patients with chronic foot problems such as: Plantar fasciitis, Osteoarthritis, Achilles tendonitis and torn soft tissue. The stem cell treatment is proving to be much more effective than traditional treatments like physical therapy or orthotic therapy.

Stem cells have the ability to replicate themselves or change into the cell type that is needed to repair damaged tissue. The therapy works by directly introducing live stem cells into the affected area causing pain. Its approved by the FDA and consistently reviewed by medical professionals to remove the potential of any communicable diseases.

Dr. Adler often travels to other states to share his knowledge with other doctors in his profession. His latest research on stem cell therapy has gained much interest among his peers in the medical industry.

When compared to traditional treatments, stem therapy is proving to be more successful and longer lasting, Dr. Adler said. We are seeing patients heal much quicker and return to their normal activities much sooner.

To learn more about stem cell replacement therapy or to schedule a consultation with a New York podiatrist at Adler Footcare, call (212) 704-4310 or visit http://www.mynycpodiatrist.com.

About Adler Footcare New York Dr. Jeffrey L. Adler, Medical/Surgical Director and owner of Adler Footcare New York has been practicing podiatric medicine since 1979 and has performed thousands of foot and ankle surgeries. Dr. Adler is board certified in Podiatric Surgery and Primary Podiatric Medicine by the American Board of Multiple Specialties in Podiatry. Dr. Adler is also a Professor of Minimally Invasive Foot Surgery for the Academy of Ambulatory Foot and Ankle Surgeons. As one of only several in the country who perform minimally invasive podiatric surgery, Dr. Adlers patients enjoy significantly reduced recovery times.

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New York Podiatrist Dr. Jeffrey Adler to Be Interviewed April 5 on NewsTalkRadio 77 WABC About the Use of Stem Cell ...

UTSA Ph.D. students bring stem cell advancements to veterinarians

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PUBLIC RELEASE DATE:

1-Apr-2014

Contact: KC Gonzalez kc.gonzalez@utsa.edu 210-458-7555 University of Texas at San Antonio

Two University of Texas at San Antonio (UTSA) biomedical engineering doctoral students, Ramon Coronado and Tony Yuan, have launched Mobile Stem Care LLC, a company that will help veterinarians treat their patients with the latest advancements in stem cell therapies.

The first of its kind in Texas, Mobile Stem Care is a mobile service that offers adipose stem cell and platelet rich plasma (PRP) isolation to veterinarians for treatments in dogs, cats and other animals suffering from degenerative diseases such as osteoarthritis or hip dysplasia, ligament and tendon injuries or non-healing wounds.

Mobile Stem Care takes adipose tissue (fat) collected from the affected animal by the veterinary doctor and isolates the adult stem cells on-site in less than 90 minutes. A concentration of the animal's stem cells and other immune-regulatory cells are returned to the doctor and injected into the damaged area of the animal to stimulate growth of healthy cells and aid healing.

Steven A. Davis, M.D., founder and director of the Dermatology & Laser Center of San Antonio, clinical professor at the UT Health Science Center at San Antonio and co-founder of privately held StemBioSys, Inc., is an investor in Mobile Stem Care.

"The first thing you invest in is people and I'm very confident in Tony and Ramon. They are energetic, bright, and they have proven themselves in a degree program with a lot of credibility," said Dr. Davis. "The stem cell arena is exciting from both a scientific and commercial standpoint. Mobile Stem Care is a unique idea and its services have value in the biomedical sphere. I think it can be successful."

Coronado and Yuan began the Ph.D. program in Biomedical Engineering in 2011 and became fast friends, sharing a common passion for science, helping others, rock-climbing and now business. Since 2012, they have worked in the laboratories of the U.S. Army Institute of Surgical Research where they have been exposed to advancements in stem cell research and treatments.

The company idea came to fruition in August 2013 when Coronado and Yuan started the Graduate Certificate program in Technology Entrepreneurship and Management offered through the UTSA College of Business and led by Cory Hallam, UTSA chief commercialization officer and director of the Center for Innovation and Technology Entrepreneurship. The 12-hour certificate is designed to help current UTSA graduate students unlock their inner entrepreneur and equip them with the fundamental skills required to start a technology company.

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UTSA Ph.D. students bring stem cell advancements to veterinarians

Big Breakthrough In Stem Cell Manufacturing Technology

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April 1, 2014

University of Nottingham

Scientists at The University of Nottingham have developed a new substance which could simplify the manufacture of cell therapy in the pioneering world of regenerative medicine.

Cell therapy is an exciting and rapidly developing area of medicine in which stem cells have the potential to repair human tissue and maintain organ function in chronic disease and age-related illnesses. But a major problem with translating current successful research into actual products and treatments is how to mass-produce such a complex living material.

There are two distinct phases in the production of stem cell products; proliferation (making enough cells to form large tissue) and differentiation (turning the basic stem cells into functional cells). The material environment required for these two phases are different and up to now a single substance that does both jobs has not been available.

Now a multi-disciplinary team of researchers at Nottingham has created a new stem cell micro-environment which they have found has allowed both the self-renewal of cells and then their evolution into cardiomyocyte (heart) cells. The material is a hydrogel containing two polymers an alginate-rich environment which allows proliferation of cells with a simple chemical switch to render the environment collagen-rich when the cell population is large enough. This change triggers the next stage of cell growth when cells develop a specific purpose.

Major priority

Professor of Advanced Drug Delivery and Tissue Engineering, Kevin Shakesheff, said:

Our new combination of hydrogels is a first. It allows dense tissue structures to be produced from human pluripotent stem cells (HPSC) in a single step process never achieved before. The discovery has important implications for the future of manufacturing in regenerative medicine. This field of healthcare is a major priority for the UK and we are seeing increasing investment in future manufacturing processes to ensure we are ready to deliver real treatments to patients when HPSC products and treatments go to trial and become standard.

The research, Combined hydrogels that switch human pluripotent stem cells from self-renewal to differentiation, is published in the Proceedings of the National Academy of Sciences (PNAS).

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Big Breakthrough In Stem Cell Manufacturing Technology

The crowd pitches in $243K (and counting) for clinical trials of a stem cell therapy for MS

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While donation-based crowdfunding has taken some industries, like consumer technology, by storm, its been dismissed by some as a source of early-stage life science funding because of the sky-high price tag that biotech and medical device R&D carries. Raising a few thousand dollars wont really do much to get a company off the ground.

But a few recent campaigns are challenging that idea, pulling in more than $100,000 in donations through Indiegogo. The latest is Tisch MS Research Center, a nonprofit research center in New York thats so far collected more than $243,000 for a Phase 1 clinical trial of a stem cell treatment for multiple sclerosis.

Tisch researchers have gotten the green light from the FDA to proceed with a safety and tolerability study of a treatment it says has the potential to reverse damage done by MS. The autoimmune disease attacks the protective coating of axons (the myelin sheath) in the brain and spinal cord, disrupting the ability of nerve signals to travel properly. That can cause numbness, pain, vision loss, difficulty walking and even paralysis.

Stem cells are hypothesized to promote repair in MS by migrating to areas of demyelination, blocking damage-forming events and enabling repair, Tisch researchers explain on their campaign page.

Their proposed therapy uses neural progenitors that are derived from adult stem cells isolated from bone marrow to promote repair in MS. Bone marrow is taken from a patients hip or sternum and sent to a lab, where stem cells are isolated and neural progenitors are derived from the sample. Then theyre administered in multiple rounds intrathecally into the cerebrospinal fluid, rather than into the bloodstream every three months.

The researchers have demonstrated proof-of-concept and feasibility in preclinical studies and are planning a Phase 1 trial that will enroll 20 progressive MS patients. They would receive six months of treatment, followed by up to 27 months of follow-up by the researchers, who say enrollment would begin once they obtain the necessary funding and IRB approval.

According to most recent estimates, the number of people living with MS has gone up 10 percent over the last five years, reaching 2.3 million. A new drug made by Biogen Idec was FDA approved last year for treating relapsing MS, and a number of treatments are in late-stage development. Cell-based therapies, though, havent advanced quite that far yet. But in a paper published in The Lancet last fall, researchers expressed optimism about the evolution and translation of such therapies for treating MS.

Tischs researchers have been working for more than 10 years on their investigational drug.

[Image credit: Tisch MS Research Center]

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The crowd pitches in $243K (and counting) for clinical trials of a stem cell therapy for MS


  1. Stem Cell Therapy