Tests NurOwn cell therapy against placebo in people with early ALS
Tests NurOwn cell treatment against a placebo in adults with early ALS.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of MSC-NTF (NurOwn) in Participants With Early Symptomatic ALS and Moderate Disease Presentation in ALS (ENDURANCE STUDY)
Key facts
- Where
- Aurora, Boston, Chicago, Davie, Jacksonville, La Jolla, Los Angeles, Philadelphia, Phoenix, Portland, Rochester, San Francisco, Tampa, and Worcester, United StatesSee the 15 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06973629, who can take part
Where in United States
- University of Colorado Anschutz Medical Campus School of MedicineAurora, United StatesNo longer taking part
- Sean M. Healey & AMG Center for ALS at Massachusetts General HospitalBoston, United StatesNo longer taking part
- Northwestern MedicineChicago, United StatesNo longer taking part
- Nova Southeastern UniversityDavie, United StatesNo longer taking part
- Mayo ClinicJacksonville, United StatesNo longer taking part
- University of California San Diego Medical CenterLa Jolla, United StatesNo longer taking part
- University of Southern CaliforniaLos Angeles, United StatesNo longer taking part
- Temple University Of the Commonwealth System of Higher EducationPhiladelphia, United StatesNo longer taking part
- Barrow Neurological InstitutePhoenix, United StatesNo longer taking part
- Providence ALS CenterPortland, United StatesNo longer taking part
- Mayo ClinicRochester, United StatesNo longer taking part
- California Pacific Medical CenterSan Francisco, United StatesNo longer taking part
- University of California San FranciscoSan Francisco, United StatesNo longer taking part
- University of South FloridaTampa, United StatesNo longer taking part
- University of Massachusetts Medical SchoolWorcester, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Brainstorm-Cell Therapeutics
- Trial code
- NCT06973629
- Record updated
- 22 May 2025
- Original description
The goal of this two-part clinical trial is:Read full original descriptionShow less
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)
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.
Inclusion: Male and female participants 18 to 75 years old (inclusive) at Screening Visit 1; ALS diagnosed as laboratory-supported probable, clinically probable, or definite as defined by the revised El Escorial criteria; Having onset of ALS symptoms, including muscle weakness, within 24 months from Screening Visit 1; ≥2 points on each item of the ALSFRS-R at the Screening Visit 1; ≤45 points on ALSFRS-R total score at Screening Visit 1; Upright slow vital capacity (SVC) measure ≥65% of predicted for gender, height, and age at Screening Visit 1; Participants must adhere to highly effective methods of contraception as specified in the study protocol.
Exclusion: Prior stem cell therapy of any kind; Any unstable clinically significant medical condition other than ALS; Any history of malignancy, within the previous 5 years, with the exception of localized skin cancers, cervical cancer in-situ or prostate cancer in-situ (with no evidence of metastasis, significant invasion, or reoccurrence within 3 years of baseline); Primary brain cancer or cancer with CNS involvement is exclusionary; Other types of motor neuron disease such as primary lateral sclerosis, progressive muscular atrophy, and progressive bulbar palsy; Active participation in any other ALS interventional study; Inability to lie flat for the duration of IT cell treatment and/or bone marrow biopsy, or inability to tolerate study procedures for any other reason; Usage of a feeding tube at Screening Visit 1 or Screening Visit 2; Pregnant women or women currently breastfeeding.