Post by stemman on Aug 18, 2014 14:10:06 GMT
finance.yahoo.com/news/fda-clears-mayo-clinic-manufacture-121000599.html
FDA Clears Mayo Clinic for Manufacture of NurOwn and Participation in BrainStorm’s Phase 2 ALS Trial
NEW YORK, NY and PETACH TIKVAH, Israel /ACCESSWIRE / August 18, 2014 / BrainStorm Cell Therapeutics (BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Mayo Clinic Human Cellular Therapy Laboratory in Rochester, Minn. for production of NurOwn™, BrainStorm’s proprietary autologous mesenchymal stem cells secreting neurotrophic factors (MSC-NTF). BrainStorm will continue working with the Mayo clinical team to complete the necessary steps to allow the site to begin enrolling subjects into its ongoing phase 2 study of NurOwn™, which is designed to evaluate the safety and efficacy of the transplantation of or NurOwn™ in patients with Amyotrophic Lateral Sclerosis (ALS).
