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Debamestrocel

Phase 3

Amyotrophic Lateral Sclerosis (ALS) | Monoclonal antibody | Neurology |Brainstorm Cell Therapeutics Inc.|Last Updated: May 22, 2025

Target and mechanism

ModalityMonoclonal antibody

Also known as Debamestrocel - MSC-NTF (NurOwn), Debamestrocel- MSC-NTF

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment200

FDA Designations

No designations recorded

Clinical trial landscape

Debamestrocel · 1 trial · 2 indications

Phase 3 1
NCT06973629Efficacy and Safety of MSC-NTF (NurOwn) in Participants With Early Symptomatic ALS and Moderate Disease Presentation in ALS (ENDURANCE STUDY)Amyotrophic Lateral Sclerosis (ALS)
NOT YET_RECRUITING200 Analytics
PHASE3NOT YET_RECRUITING
Efficacy and Safety of MSC-NTF (NurOwn) in Participants With Early Symptomatic ALS and Moderate Disease Presentation in ALS (ENDURANCE STUDY)
Amyotrophic Lateral Sclerosis (ALS)
NCT06973629200
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Study Endpoints

Primary Endpoints

Change in the ALSFRS-R total score from baseline to Week 24
From 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) assessments
From 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).

Secondary Endpoints

Change in SVC (%predicted) from baseline to Week 24
From baseline to Week 24
Change in HHD from baseline to Week 24
From baseline to Week 24
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Debamestrocel - MSC-NTF (NurOwn)EXPERIMENTALNTF-secreting mesenchymal stem cells (MSC-NTF cells) are a novel cell-therapeutic approach aimed at effectively delivering NTFs directly to the site of damage in ALS patients
PlaceboPLACEBO_COMPARATORPlacebo is comprised of Dulbecco Modified Eagle Medium (DMEM)

Interventions

NameTypeDescription
Debamestrocel - MSC-NTF (NurOwn)BIOLOGICALMSC-NTF cells suspended in excipient Dulbecco Modified Eagle Medium (DMEM).
PlaceboBIOLOGICALDulbecco Modified Eagle Medium (DMEM).
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: 1. Male and female participants 18 to 75 years old (inclusive) at Screening Visit 1. 2. ALS diagnosed as laboratory-supported probable, clinically probable, or definite as defined by the revised El Escorial criteria. 3. Having onset of ALS symptoms, including muscle weakness, wi...

Countries:United States
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