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Study identifier: NCT06973629 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Not Yet Recruiting

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

Condition: Amyotrophic Lateral Sclerosis (ALS) · Amyotrophic Lateral Sclerosis  ·  Sponsor: Brainstorm-Cell Therapeutics

PhasePhase 3
Planned participants200
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Chief Medical Officer, Brainstorm Cell Therapeutics, MD  ·  201-488-0460  ·  ClinicalTrial@Brainstorm-cell.com

Always discuss trial participation with your own doctor first.

Locations (15)

Barrow Neurological InstitutePhoenix, Arizona, United States
University of California San Diego Medical CenterLa Jolla, California, United States
University of Southern CaliforniaLos Angeles, California, United States
California Pacific Medical CenterSan Francisco, California, United States
University of California, San FranciscoSan Francisco, California, United States
University of Colorado Anschutz Medical Campus School of MedicineAurora, Colorado, United States
Nova Southeastern UniversityDavie, Florida, United States
Mayo ClinicJacksonville, Florida, United States
University of South FloridaTampa, Florida, United States
Northwestern MedicineChicago, Illinois, United States
Sean M. Healey & AMG Center For ALS At Massachusetts General HospitalBoston, Massachusetts, United States
University of Massachusetts Medical SchoolWorcester, Massachusetts, United States

+ 3 more locations — full list on the registry record.

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