Efficacy and Safety of MSC-NTF (NurOwn) in Participants With Early Symptomatic ALS and Moderate Disease Presentation in ALS (ENDURANCE STUDY)

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Amyotrophic Lateral Sclerosis (ALS), Amyotrophic Lateral Sclerosis

In brief

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 facts

Study ID

NCT06973629

Run by

Brainstorm-Cell Therapeutics

People needed

200

Starts

2025-06-30

Expected to finish

2029-05-01

Last updated by the study team

2025-05-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Prior stem cell therapy of any kind.
• 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.
• 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.
• Usage of a feeding tube at Screening Visit 1 or Screening Visit 2.
• Pregnant women or women currently breastfeeding.

Where it is running

• Barrow Neurological Institute — Phoenix, Arizona, United States
• University of California San Diego Medical Center — La Jolla, California, United States
• University of Southern California — Los Angeles, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• University of California, San Francisco — San Francisco, California, United States
• University of Colorado Anschutz Medical Campus School of Medicine — Aurora, Colorado, United States
• Nova Southeastern University — Davie, Florida, United States
• Mayo Clinic — Jacksonville, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Northwestern Medicine — Chicago, Illinois, United States
• Sean M. Healey & AMG Center For ALS At Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Massachusetts Medical School — Worcester, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Providence ALS Center — Portland, Oregon, United States
• Temple University Of The Commonwealth System of Higher Education — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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