A Statement on Stem Cell Trial Developments: August 24, 2012

In November 2011, Tisch MS was approved by the International Cellular Medicine Society (ICMS), an Institutional Review Board (IRB), to begin a phase I safety and tolerability trial of Mesenchymal Stem Cell-Derived Neural Progenitors in 20 selected Multiple Sclerosis patients. The Food and Drug Administration (FDA) recently began an audit of ICMS and questioned whether the Tisch MS protocol was exempt from FDA regulation. Pending the final outcome of the FDA audit, all further work on Tisch MS’s stem cell trial is suspended. For further information please contact the study coordinators Deirdre Dulak (646-557-3860) and Daniel Koffler (646-557-3852).