Discover. Innovate. Deliver.
Delivering on the Promise
of Cellular Therapeutics
BrainStorm is a leader in developing innovative autologous cellular therapies
for highly debilitating neurodegenerative diseases.
Defining a new class of autologous cellular therapeutics
WHAT WE DO
BrainStorm’s autologous MSC-NTF cell therapy has received Fast Track designation from the U.S. Food and Drug Administration (U.S. FDA) in amyotrophic lateral sclerosis (ALS) and has additionally been granted Orphan Status by the U.S. FDA and the European Medicines Agency (EMA).
BrainStorm is enrolling a phase 3 pivotal trial using repeat-administration of autologous MSC-NTF cells in ALS in the United States. Enrollment completion is anticipated in the first half of 2019 and will enable a Biologics License Application (BLA) filing for U.S. FDA approval in ALS.