NurOwn (Debamestrocel) for Early ALS
This study is testing a treatment called Debamestrocel (NurOwn) for people with early symptoms of Amyotrophic Lateral Sclerosis (ALS). Researchers want to see if NurOwn is safe and effective compared to a placebo (a substance with no medicine). You could be eligible if you are between 18 and 75 years old and were diagnosed with ALS within the last 24 months. The study will measure changes in your ALS symptoms using a special score (ALSFRS-R) over 24 weeks, and also track any side effects for 48 weeks. The current status of this study is unclear.
- Study design
- This is a Phase 3b study with approximately 200 participants. It starts with a 24-week period where you will randomly receive either NurOwn or a placebo, followed by a 24-week period where all participants receive NurOwn.
- What's involved
- You would receive injections of NurOwn or placebo every 8 weeks for 24 weeks, then NurOwn every 8 weeks for another 24 weeks. You will also have clinic visits for checkups and tests approximately every 8 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track side effects for 48 weeks after you start treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Efficacy and Safety of MSC-NTF (NurOwn) in Participants With Early Symptomatic ALS and Moderate Disease Presentation in ALS (ENDURANCE STUDY)
At a glance
Conditions
NCT06973629
Where you'd take part
This study runs at 15 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Barrow Neurological Institute
Phoenix, Arizonastudy coordinator listed
California Pacific Medical Center
San Francisco, Californiastudy coordinator listed
Mayo Clinic
Jacksonville, Floridastudy coordinator listed
Mayo Clinic
Rochester, Minnesotastudy coordinator listed
Northwestern Medicine
Chicago, Illinoisstudy coordinator listed
Nova Southeastern University
Davie, Floridastudy coordinator listed
Providence ALS Center
Portland, Oregonstudy coordinator listed
Sean M. Healey & AMG Center For ALS At Massachusetts General Hospital
Boston, Massachusettsstudy coordinator listed
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Change in the ALSFRS-R total score from baseline to Week 24From baseline to Week 24
To evaluate the efficacy of NurOwn compared to placebo in the treatment of participants with ALS based on the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) which is a 12-item clinician-administered questionnaire. Each item is scored between 0 and 4, with the total ALSFRS-R score between 0 and 48 where a higher score reflects a better outcome.
- Frequency and severity of adverse events including treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), death, abnormalities in laboratory evaluations, physical examinations, vital signs and electrocardiogram (ECG) assessmentsFrom baseline to Week 48
To evaluate the safety and tolerability of NurOwn in the treatment of participants with ALS throughout the study including the DBPC period (Part A) to Week 24 and the Open Label Extension (Part B).