BrainStorm Cell Therapeutics said the U.S. Food and Drug Administration approved the start of a mid-stage clinical trial of its adult stem cell treatment for patients with amyotrophic lateral sclerosis (ALS).
The Phase II trial will be launched initially at Massachusetts General Hospital in Boston and the University of Massachusetts Memorial Hospital in Worcester.
Dana-Farber Cancer Institute’s Connell O’Reilly Cell Manipulation Core Facility will manufacture BrainStorm’s NurOwn cells for these two clinical sites. The trial will also be conducted at the Mayo Clinic, the Israel-based company said on Sunday. The trials are expected to start soon.
ALS, also known as Lou Gehrig’s Disease, is a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord.
BrainStorm’s Phase II trial is designed to evaluate the safety and efficacy of transplantation of the stem cells in 48 ALS patients. The cells will be administered via intramuscular and intrathecal injection
Read the full, original story: FDA okays start of BrainStorm stem cell trial in ALS patients