200 ALS Patients Finish Dosing in Phase 3 Trial of NurOwn Cell Therapy

Patient dosing has finished in the pivotal Phase 3 trial assessing the safety and efficacy of repeat administrations of NurOwn, a cell-based therapy for people with amyotrophic lateral sclerosis (ALS), BrainStorm Cell Therapeutics, the therapy’s developer, announced.

The Phase 3 trial (NCT03280056), which enrolled about 200 participants, is underway at six U.S. sites: the University of California, IrvineCedars-Sinai Medical CenterCalifornia Pacific Medical CenterMassachusetts General Hospital; the University of Massachusetts Medical School; and the Mayo Clinic.

Patients were randomly assigned to either three doses of NurOwn or a placebo, both administered every other month by injections directly into the spinal canal (intrathecal) over a period of four months.