BrainStorm Cell Therapeutics announced that the Food and Drug Administration (FDA) has granted Fast Track status to NurOwn for the treatment of Amyotrophic Lateral Sclerosis (ALS, or Lou Gehrig’s Disease). NurOwn consists of autologous mesenchymal stem cells that have been induced to secrete neurotrophic factors.

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NurOwn is currently being studied in a randomized, double-blind, placebo-controlled Phase 2 trial designed to evaluate the safety and preliminary efficacy of NurOwn in ALS patients. Participants in this trial received combined intramuscular and intrathecal administration of NurOwn cells in three cohorts with increasing doses. All patients were followed for six months after transplantation.

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