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Thursday, October 3, 2013

Approval of Phase I Stem Cell Study in Progressive MS

The stem cell research division of the Tisch MS Research Center of New York has announced the FDA approval of a Phase I stem cell study in individuals with progressive MS. The study will use a patient's own stem cells, taken from his or her bone marrow, in an open label, Phase I clinical trial. According to the center's news article, approximately 20 progressive MS patients, recruited from the existing patient population of the International Multiple Sclerosis Management Practice (IMSMP), will be initially enrolled.

The article also notes that the Tisch MS Research Center stem cell trial is the first of its kind in the United States and incorporates several key advantages in terms of the type of stem cells being used and how they are administered (via multiple rounds of treatment into the cerebrospinal fluid). The center states that this FDA approval is the culmination of more than a decade of research into the therapeutic potential of stem cells for MS patients. Their initial ("proof of concept") studies with an animal model of MS showed that the injected stem cells migrated to areas of demyelination and may have affected the rate of repair


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