BrainStorm is proceeding with a randomized, double-blind, placebo-controlled multi-dose Phase 3 trial that is being conducted at multiple U.S. sites
Additional information on the NurOwn® clinical trial development program can be found Here
For information on enrollment in the NurOwn® phase 3 trial contact one of the clinical trial sites for details and screening.
United States, California
University of California Irvine Alpha Stem Cell Clinic Recruiting
Irvine, California, United States, 92697
Contact: Robert Zhou 949-824-3990 firstname.lastname@example.org
Principal Investigator: Namita A. Goyal, MD
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Taylor J Mezoian 617-643-0312 TMEZOIAN@mgh.harvard.edu
Principal Investigator: James D Berry, MD
Principal Investigator: Merit E. Cudkowicz, MD Massachusetts General Hospital
Principal Investigator: Robert H. Brown, MD, PhD UMass Medical School
Principal Investigator: Anthony J. Windebank, MD Mayo Clinic
Principal Investigator: Namita A. Goyal, MD UC Irvine
Principal Investigator: Robert G. Miller, MD California Pacific Medical Center (CPM) Research Institute
Additional information is posted on clinicaltrials.gov identifier (NCT number): NCT03280056.
We have undertaken three clinical trials in ALS to date
- A single-arm, open label phase 1/2 study – completed.
- A single-arm, open label, dose-escalation phase 2a study – completed.
- A randomized, double-blind, placebo-controlled phase 2 study – completed.
In all three trials, the primary endpoints were the safety and tolerability of a single intramuscular, intrathecal or simultaneous intramuscular and intrathecal administration. Key secondary efficacy endpoints included the rate of change in the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) and in forced vital capacity (FVC) during the post-treatment period compared to a three month pre-treatment run-in period.