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NOT YET RECRUITING
NCT06973629
PHASE3

Efficacy and Safety of MSC-NTF (NurOwn) in Participants With Early Symptomatic ALS and Moderate Disease Presentation in ALS (ENDURANCE STUDY)

Sponsor: Brainstorm-Cell Therapeutics

View on ClinicalTrials.gov

Summary

The goal of this two-part clinical trial is: 1\) to evaluate the safety and efficacy of Debamestrocel - MSC-NTF (NurOwn) compared to placebo in participants with early symptomatic ALS and moderate disease presentation in ALS; followed by 2) further evaluation by providing NurOwn to all participants in an open label extension period. Researchers will compare NurOwn to a placebo (a look-alike substance that contains no drug) to evaluate the efficacy of NurOwn compared to placebo in the treatment of participants with ALS. Participants will: Receive NurOwn or a placebo every 8 weeks for 24 weeks. After that, every participant will receive NurOwn every 8 weeks for an additional 24 weeks. They will visit the clinic approximately every 8 weeks for checkups and tests.

Official title: A Two-Part Phase 3b Randomized, Double-Blind, Placebo-Controlled, Followed by Open-Label Extension, Multicenter Study of the Efficacy and Safety of MSC-NTF (NurOwn) in Participants With With Early Symptomatic and Moderate Disease Presentation in Amyotrophic Lateral Sclerosis (ALS)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2025-06-30

Completion Date

2029-05-01

Last Updated

2025-05-22

Healthy Volunteers

No

Interventions

BIOLOGICAL

Debamestrocel - MSC-NTF (NurOwn)

MSC-NTF cells suspended in excipient Dulbecco Modified Eagle Medium (DMEM).

BIOLOGICAL

Placebo

Dulbecco Modified Eagle Medium (DMEM).

Locations (15)

Barrow Neurological Institute

Phoenix, Arizona, United States

University of California San Diego Medical Center

La Jolla, California, United States

University of Southern California

Los Angeles, California, United States

California Pacific Medical Center

San Francisco, California, United States

University of California, San Francisco

San Francisco, California, United States

University of Colorado Anschutz Medical Campus School of Medicine

Aurora, Colorado, United States

Nova Southeastern University

Davie, Florida, United States

Mayo Clinic

Jacksonville, Florida, United States

University of South Florida

Tampa, Florida, United States

Northwestern Medicine

Chicago, Illinois, United States

Sean M. Healey & AMG Center For ALS At Massachusetts General Hospital

Boston, Massachusetts, United States

University of Massachusetts Medical School

Worcester, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Providence ALS Center

Portland, Oregon, United States

Temple University Of The Commonwealth System of Higher Education

Philadelphia, Pennsylvania, United States