Stem Cell Trial Update: July 15th, 2013

Monday, July 15, 2013

Tisch MS Research Center of New York has formally submitted a response to the Food and Drug Administration’s (FDA) clinical hold on our proposed Phase I trial of Mesenchymal Stem Cell-Derived Neural Progenitors in the treatment of multiple sclerosis. Per agency rules, this submission necessitates a reply from the FDA within 30 days of filing. Within another 30 days of the FDA’s reply, we expect to schedule a meeting in order to discuss the FDA’s comments on our submission. Consequently, Tisch MS researchers will have an opportunity within a maximum of two months to make a thorough presentation to the FDA in defense of our clinical trial proposal. Any further updates to the status of the stem cell trial or results of consultations and meetings with the FDA will be posted in this space upon their receipt.

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