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Potential MS Stem Cell Therapy Moves into Phase 2

January 25, 2016

The Tisch MS Research Center of New York recently announced that its stem cell-based therapy as a potential treatment for MS will move into Phase 2 clinical testing after encouraging results in a Phase 1 trial. This was done after the FDA advised to do so.

No adverse effects were reported after Tisch determined the treatment’s tolerability and safety during a phase 1 trial. 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.

“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 has already begun seeking financial backing to begin recruiting its first patients and the trial is expected to take place this summer.