Efficacy and Safety of MSC-NTF (NurOwn) in Participants With Early Symptomatic ALS and Moderate Disease Presentation in ALS (ENDURANCE STUDY)
Public ClinicalTrials.gov record NCT06973629. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06973629
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 200 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 29, 2025
- Primary completion
- Oct 31, 2028
- Completion
- Apr 30, 2029
- Last update posted
- May 21, 2025
2025 – 2029
United States locations
- U.S. sites
- 15
- U.S. states
- 9
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Barrow Neurological Institute | Phoenix | Arizona | 85013 | — |
| University of California San Diego Medical Center | La Jolla | California | 92093 | — |
| University of Southern California | Los Angeles | California | 90033 | — |
| California Pacific Medical Center | San Francisco | California | 94115 | — |
| University of California, San Francisco | San Francisco | California | 94143 | — |
| University of Colorado Anschutz Medical Campus School of Medicine | Aurora | Colorado | 80045 | — |
| Nova Southeastern University | Davie | Florida | 33328 | — |
| Mayo Clinic | Jacksonville | Florida | 32224 | — |
| University of South Florida | Tampa | Florida | 33612 | — |
| Northwestern Medicine | Chicago | Illinois | 60611 | — |
| Sean M. Healey & AMG Center For ALS At Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| University of Massachusetts Medical School | Worcester | Massachusetts | 01655 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Providence ALS Center | Portland | Oregon | 97213 | — |
| Temple University Of The Commonwealth System of Higher Education | Philadelphia | Pennsylvania | 19140 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06973629, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 21, 2025 · Synced Sep 1, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06973629 live on ClinicalTrials.gov.