Phase I trial of Spinal Cord Derived Stem Cells

Neuralstem, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to commence a Phase I trial to treat Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig’s disease) with its spinal cord stem cells.

The Rockville, MD-based Neuralstem is the first company to commence a stem cell trial to treat ALS.  The trial will study the safety of Neuralstem’s cells and the surgical procedures and devices required for multiple injections of Neuralstem’s cells directly into the grey matter of the spinal cord. 

The FDA-approved Phase I of the trial will consit of 12 patients who will receive five-to-ten stem cell injections in the lumbar area of the spinal cord.  The patients will be examined at regular intervals post-surgery, with final review of the data to come about 24 months later.

For enrollment information, please click here.

January 2010