Neuralstem, Inc. (CUR) Obtains FDA Approval for Phase II Stem Cell Trial in ALS
Today, Neuralstem announced it has received FDA approval to commence a Phase II trial using NSI-566 spinal cord-derived human neural stems cells to treat amyotrophic lateral sclerosis, commonly known as ALS or Lou Gehrig’s disease. The Phase II dose escalation and safety trial will expand two centers: Emory University Hospital in Atlanta, Ga., where Phase I was recently completed; and ALS Clinic at the University of Michigan Health System in Ann Arbor, Mich. Both expansions are subject to approval by each institution’s Institutional Review Board. This trial is designed to treat up to 15 patients in five different dosing cohorts.…