Efficacy and Safety of MSC-NTF (NurOwn) in Participants With Early Symptomatic ALS and Moderate Disease Presentation in ALS (ENDURANCE STUDY) (NCT06973629)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Barrow Neurological Institute — Phoenix, Arizona
Age range: 18 Years to 75 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (15 Sites)
- Barrow Neurological Institute — Phoenix, Arizona
- University of California San Diego Medical Center — La Jolla, California
- University of Southern California — Los Angeles, California
- California Pacific Medical Center — San Francisco, California
- University of California, San Francisco — San Francisco, California
- University of Colorado Anschutz Medical Campus School of Medicine — Aurora, Colorado
- Nova Southeastern University — Davie, Florida
- Mayo Clinic — Jacksonville, Florida
- University of South Florida — Tampa, Florida
- Northwestern Medicine — Chicago, Illinois
- Sean M. Healey & AMG Center For ALS At Massachusetts General Hospital — Boston, Massachusetts
- University of Massachusetts Medical School — Worcester, Massachusetts
- Mayo Clinic — Rochester, Minnesota
- Providence ALS Center — Portland, Oregon
- Temple University Of The Commonwealth System of Higher Education — Philadelphia, Pennsylvania
📞 Contact the Study Coordinator
Phone: (201) 488-0460
Email: ClinicalTrial@Brainstorm-cell.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Amyotrophic Lateral Sclerosis (ALS)
- HEALEY ALS Platform Trial - Regimen I NUZ-001 — Boston, Massachusetts
- A Clinical Trial to Learn About the Effects of VHB937 in People With Amyotrophic Lateral Sclerosis (ALS) — La Jolla, California
- Resiliency Intervention for Patients With ALS and Their Care-Partners — Boston, Massachusetts
- Safety Study of XT-150 in Participants With ALS — Phoenix, Arizona
- A Phase Ⅰ/Ⅱa Study of SNUG01 in Adult Subjects With ALS — Boston, Massachusetts
Explore by condition: All Amyotrophic Lateral Sclerosis (ALS) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.