Phase 2 Stem Cell Study for ALS Approved

Brain Storm Cell Therapeutics announced that the Phase 2 clinical trial of NurOwn for patients with Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig’s Disease, has received FDA approval to begin. NurOwn is an autologous, adult stem cell therapy technology in which Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors (“MSC-NTF”) are administered via combined intramuscular and intrathecal injections to differentiate bone marrow-derived mesenchymal stem cells (MSC) into “MSC-NTF” cells.

The upcoming Phase 2 trial will be a randomized, double-blind, placebo controlled multi-center study of 48 ALS patients that will evaluate the safety and efficacy of transplantation of NurOwn. Patients will be followed monthly for approximately three months prior to transplantation and six months afterward. The primary objective of the study will be safety and tolerability, as defined by a measure of the number of patients with adverse events.

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A Phase 1 clinical trial successfully met its primary endpoints, with significant observed improvements in areas such as Amyotrophic Lateral Sclerosis Functional Rating Scale (ALS-FRS) score and total neurological examination score. The FDA granted NurOwn Orphan Drug Designation for the treatment of ALS in 2011.

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