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jodyMSvideo2012 0001
Center for Biologics Evaluation and Research Consumer Affairs Branch Food and Drug Administration 1401 Rockville Pike, Suite 200N/HFM-47 Rockville, MD 20852-1448 We are writing to encourage the FDA and the Center for Biologics Evaluation and Research (CBER) to approve a clinical trial of mesenchymal stem cell derived neural progenitors (MSC-NPs) in the treatment of Secondary Progressive Multiple Sclerosis (SPMS). The initial 20 person trial will be conducted at the Multiple Sclerosis Research Center of New York (MSRCNY) under the direction of Dr. Saud Sadiq, neurologist and director of the MSRCNY. Dr. Sadiq was previously the head of Neurology at St. Luke #39;s Roosevelt Hospital in New York City (NYC). In 2006, he started this research center in NYC working only on MS. In November 2011, the MSRCNY received approval from the Institutional Review Board (IRB) of the International Cellular Medicine Society (ICMS) to conduct this trial for patients with SPMS, the first of its kind ever done in the US. This trial is very specialized as it uses a patient #39;s own adult stem cells that are removed from the patient #39;s breast bone marrow, grown, isolated and injected into the spinal fluid (intrathecal) where the disease attacks the myelin. The trial will last for 3 years with stem cell treatments every 3 months for the first year and potentially more, depending on the many evaluations to determine physical and mental progress. MSRCNY requested approval in the past and is currently seeking ...From:Jennifer DavidViews:2 0ratingsTime:08:46More inNonprofits Activism

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