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Sunday, January 24, 2016
Potential MS Stem Cell Therapy Moves into Phase 2 Trial for 1st Time in US
Tisch MS Research Center advised by FDA to advance testing based on promising Phase 1 clinical results
The FDA advised Tisch MSRCNY to continue its research after the treatment’s tolerability and safety were determined in the Phase 1 trial, with no adverse effects reported. The Phase 2 clinical trial will be a placebo-controlled, double-blind, randomized study with 40 patients in a crossover design: stem cells taken from the patients’ bone marrow will be processed to become brain-like neural cells, a method developed by Tisch MSRCNY and unique to the institution.
“Our unprecedented Phase I results have propelled us into the next phase of research,” said Dr. Saud A. Sadiq, the study’s lead investigator and Tisch MSRCNY’s chief research scientist, in a center news release. “No treatment has shown reversal of established disability until now. The objective improvement experienced in bladder function, vision and walking speed in both secondary and primary progressive MS is remarkable. We now plan to establish efficacy of stem cells as a reparative therapy in Phase II.”
Tisch MSRCNY is now seeking financial support to start recruiting its first patients, and the trial is expected to be launched in the summer of 2016.