Neuralstem Receives FDA Approval To Initiate Phase I Trial For ALS

Neuralstem has revealed that the 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 company said that 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.

Richard Garr, president and CEO of Neuralstem, said: “The beginning of our clinical trial program is a major step towards achieving Neuralstem’s goal of treating ALS, a fatal neurodegenerative disease for which currently there is no effective treatment or cure. While this trial aims to primarily establish safety and feasibility data in treating ALS patients, we also hope to be able to measure a slowing down of the ALS degenerative process.”

Eva Feldman, who will direct the Neuralstem clinical trial program for ALS, said: “We are very excited about this clinical trial. This is a major advancement in what still could be a long road to a new and improved treatment for ALS. ALS is a terrible disease that ultimately kills by paralysis.

“In work with animals, these spinal cord stem cells both protected at-risk motor neurons and made connections to the neurons controlling muscles. We don’t want to raise expectations unduly, but we believe these stem cells could produce similar results in patients with ALS.”