Efficacy and Safety of MSC-NTF (NurOwn) in Participants With Early Symptomatic ALS and Moderate Disease Presentation in ALS (ENDURANCE STUDY)
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- Brainstorm-Cell Therapeutics
- Study ID
- NCT06973629
- Phase
- PHASE3
- Status
- Not Yet Recruiting
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Conditions
- Amyotrophic Lateral Sclerosis
- Amyotrophic Lateral Sclerosis (ALS)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Debamestrocel - MSC-NTF (NurOwn) — BIOLOGICALMSC-NTF cells suspended in excipient Dulbecco Modified Eagle Medium (DMEM).
- Placebo — BIOLOGICALDulbecco Modified Eagle Medium (DMEM).
Study Details
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.
Key Dates
- Start date
- Jun 30, 2025
- Status verified
- May 2025
- Primary completion
- Nov 1, 2028
- Completion
- May 1, 2029
Study Design
- Enrollment
- 200 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Debamestrocel - MSC-NTF (NurOwn)NTF-secreting mesenchymal stem cells (MSC-NTF cells) are a novel cell-therapeutic approach aimed at effectively delivering NTFs directly to the site of damage in ALS patients
- Placebo Comparator: PlaceboPlacebo is comprised of Dulbecco Modified Eagle Medium (DMEM)
Primary Outcome Measure
Change in the ALSFRS-R total score from baseline to Week 24 [ Time Frame: From baseline to Week 24 ]
Central Contacts
- Chief Medical Officer, Brainstorm Cell Therapeutics, MD201-488-0460
Locations (15)
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