A Statement on Stem Cell Trial Developments: September 13, 2012

The Food and Drug Administration (FDA) made an unannounced site visit to Tisch MS during the week of August 27 in connection with the proposed Tisch MS clinical trial of Mesenchymal Stem Cell-Derived Neural Progenitors (MSC-NPs). As noted in this space in August, the FDA had previously initiated an audit of the International Cellular Medicine Society (ICMS), the Institutional Review Board (IRB) which had granted approval to the MSCRNY study last November. Although a final resolution of the ICMS audit has not yet been released, observations made during the FDA inspection are outlined in the Form 483 issued to ICMS which can be accessed from the ICMS website.

Conversely, the inspection of Tisch MS concluded that Tisch MS continues to be in full regulatory compliance and no citations were issued. Nevertheless, the FDA has advised us that a clinical trial of stem cell therapy falls under FDA jurisdiction as an Investigational New Drug (IND), and that therefore IRB approval in the absence of additional FDA-IND approval is not a sufficient legal basis for initiating the stem cell trial. Consequently, all work on the stem cell trial is suspended pending an appropriate resolution of the foregoing regulatory issues.

It should be emphasized that Tisch MS wishes to be in full compliance with the FDA on this and all other health matters. Any changes in the status of the stem cell trial will be posted in this space (and patients can infer that no change has occurred in the absence of an online announcement). The prospects for stem cell therapy in MS will also be discussed at the upcoming Tisch MS symposium on Sunday, October 21.