Neuralstem Receives FDA Approval for Phase II Study

Neuralstem Inc. just announced that the FDA has approved their Phase II study to inject human spinal cord-derived stem cells (NSI-566) directly into the spinal cord for the treatment of ALS. The goal of the Phase II study is to determine the maximum tolerated dose of NSI-566 in people with ALS. Neuralstem Chairman and Chief Scientific Officer Dr. Karl Johe said “As a result of the excellent safety and tolerability demonstrated in Phase I, we will be able to proceed more aggressively in Phase II. In Phase I, we started with just five injection sites per patient, and advanced to a maximum of 15 injections of 100,000 cells each. In Phase II, we will advance up to a maximum of 40 injections, and 400,000 cells per injection based on safety.” Pending Institutional Review Board approval, the Phase II trial will be conducted at two locations including Emory University Hospital in Atlanta, Georgia, the site location of the Phase I trial, and the ALS Clinic at the University of Michigan Health System, in Ann Arbor, Michigan. To learn more about the details of this Phase II dose escalation study, click the link below.

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