The U.S. Food and Drug Administration (FDA) has approved the initiation of a Phase II safety and efficacy trial of Brainstorm’s stem cell therapy for ALS. This landmark study is the first Phase II double-blinded stem cell study to be conducted for ALS. Brainstorm’s NurOwn stem cells are autologous, adult mesenchymal stem cells that have been induced to differentiate into cells producing neurotrophic factors. NurOwn cells, which appear to be safe based on earlier clinical studies, will be administered to ALS patients via intramuscular and intrathecal injections. The study will enroll 48 patients at Massachusetts General Hospital, Boston, the University of Massachusetts Memorial Hospital, Worcester and the Mayo Clinic in Ohio.
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