FDA OKs Neuralstem’s ALS clinical trial

Neuralstem Inc., of Rockville, a biotherapeutic company developing products to treat central nervous system disorders with patented stem cell technology, said it received approval from the Food and Drug Administration to begin a Phase II trial using spinal cord-derived human neural stem cells to treat amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease).

The Phase II dose escalation and safety trial will expand to two centers, Emory University Hospital in Atlanta, Ga., where Phase I testing was recently completed, and the ALS Clinic at the University of Michigan Health System, in Ann Arbor, Mich.