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FDA Approves Neural Stem Cell Clinical Trial

8/14/2013

The U.S. Food and Drug Administration (FDA) has approved autologous, mesenchymal stem cell-derived neural progenitor cells (MSC-NPs) as an Investigational New Drug (IND) for a Phase I clinical trial in the treatment of multiple sclerosis at the Tisch MS Research Center of New York, the center has announced.   

The groundbreaking study will investigate a regenerative strategy using stem cells harvested from the patient's own bone marrow. These stem cells will be injected intrathecally (into the cerebrospinal fluid surrounding the spinal cord). Preclinical testing found that the injection of these cells may decrease brain inflammation and promote myelin repair and/or neuroprotection.

Approximately 20 progressive MS patients, recruited from the existing patient population of the International Multiple Sclerosis Management Practice (IMSMP), will be initially enrolled in this open label safety and tolerability study.

"To my knowledge, this is the first FDA-approved stem cell trial in the United States to investigate direct injection of stem cells into the cerebrospinal fluid of MS patients, and represents an exciting advance in MS research and treatment," said Dr. Saud A. Sadiq, Senior Research Scientist at Tisch MS Research Center of New York and the study's principal investigator. 

The clinical application of autologous neural progenitors in MS is the culmination of a decade of stem cell research conducted by a team of scientists headed by Dr. Sadiq and by Dr. Violaine Harris, research scientist at Tisch MS Research Center. 

Participants will undergo a single bone marrow collection procedure, from which MSC-NPs will be isolated, expanded, and tested prior to injection. Participants will receive three rounds of injections at three month intervals. Safety and efficacy parameters will be evaluated in all participants through regular follow up visits.

In this and subsequent studies, researchers hope to define the optimal therapeutic dose and dosing frequency of stem cells, the best route (or combined routes) of administration, whether or not stem cells should be used in combination with other disease modifying treatments, and which patients are most likely to benefit from this treatment.

Enrollment in the clinical trial will begin after approval of the protocol has been obtained from an Institutional Review Board (IRB) and funding has been secured. A definitive date for enrollment to begin will be announced at that time, prior to which no study activities will be conducted. Questions about the study protocol, enrollment criteria, and other non-clinical matters should be directed to the Study Coordinators Daniel Koffler (dkoffler@tischms.org or 646-557-3852) and Sydney Chirls (schirls@tischms.org or 646-557-3860). Clinical questions will be forwarded to one of the research nurses. For more information on this study visit: www.tischms.org.

 

 



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