U.S. Food and Drug Administration Approves Start of BrainStorm Stem Cell Trial for People with ALS

April 28, 2014

On April 27, the Israel-based BrainStorm Cell Therapeutics said the U.S. Food and Drug Administration (FDA) has approved the start of a mid-stage clinical trial of its adult stem cell treatment for people with ALS.

The Phase II trial, which is designed to evaluate the safety and efficacy of stem cell transplantation into 48 people with the disease, will be first launched 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 the company’s NurOwn cells for these two clinical sites. In addition, the trial will also be conducted at the Mayo Clinic.

Earlier clinical trials of this treatment have shown it was well tolerated and safe.

For additional information, read the Reuters article.

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