Status:
NOT_YET_RECRUITING
Efficacy and Safety of MSC-NTF (NurOwn) in Participants With Early Symptomatic ALS and Moderate Disease Presentation in ALS (ENDURANCE STUDY)
Lead Sponsor:
Brainstorm-Cell Therapeutics
Conditions:
Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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 di...
Detailed Description
This is a multicenter, Phase 3b study to assess the efficacy and safety of NurOwn in participants with early symptomatic ALS and moderate disease presentation in ALS. The study comprises two parts: a ...
Eligibility Criteria
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.
- 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.
Key Trial Info
Start Date :
June 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2029
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06973629
Start Date
June 30 2025
End Date
May 1 2029
Last Update
May 22 2025
Active Locations (15)
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1
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
2
University of California San Diego Medical Center
La Jolla, California, United States, 92093
3
University of Southern California
Los Angeles, California, United States, 90033
4
California Pacific Medical Center
San Francisco, California, United States, 94115