Investors

Clinical trials in ALS and progressive MS

Autologous MSC-NTF cells - NurOwn® (debamestrocel) - are manufactured from a patient’s own bone marrow cells. We isolate mesenchymal stem cells, grow them under special conditions to induce secretion of multiple growth factors important in the nervous system, then inject the cells into the cerebrospinal fluid.

Completed trials

Registered on ClinicalTrials.gov

Amyotrophic lateral sclerosis

Phase
Location
Design
Participants
Phase 1/2 NCT01051882

Israel

12
Phase 2a NCT01777646

Israel

14
Phase 2 NCT02017912

United States

48
Phase 3 NCT03280056

United States

189

Progressive multiple sclerosis

Phase
Location
Design
Participants
Phase 2 NCT03799718

United States

20 enrolled · 18 treated · 16 completed

Phase 3 trial sites in ALS

The completed Phase 3 trial (NCT03280056) took place at six clinical centers in the United States.

  • Irvine, California

    UC Irvine Alpha Stem Cell Clinic

    Principal investigator

    Namita A. Goyal, MD

  • Los Angeles, California

    Cedars-Sinai Medical Center

    Principal investigator

    Robert H. Baloh, MD

  • San Francisco, California

    California Pacific Medical Center

    Principal investigator

    Robert G. Miller, MD

  • Boston, Massachusetts

    Massachusetts General Hospital

    Principal investigator

    James D. Berry, MD

  • Rochester, Minnesota

    Mayo Clinic

    Principal investigator

    Anthony Windebank, MD

  • Worcester, Massachusetts

    University of Massachusetts Medical School

    Principal investigator

    Robert Brown, DPhil, MD

Next study

The Phase 3b trial in ALS

The Phase 3b trial (Study BCT-006-US) will be a two-part, multicenter study designed to assess the efficacy and safety of NurOwn in patients with ALS. The entry criteria will enroll participants earlier in the course of their disease, having the onset of ALS symptoms, including limb weakness, within the prior 24 months, and upright slow vital capacity greater than or equal to 65% of predicted for gender, height and age. Patients will also be allowed to receive concomitant treatment of an approved standard of care.

The protocol and statistical analysis plan have been granted a Special Protocol Assessment by the FDA - meaning they are adequate to support a future Biologics License Application.

Full Phase 3b trial design

Continue

BrainStorm's autologous MSC-NTF cell therapy (NurOwn®, debamestrocel) is investigational and has not been approved by the FDA or any other regulatory authority. This page is not medical advice - please speak with your own care team.