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)
Brainstorm Cell Therapeutics is advancing its investigational product, NurOwn (Debamestrocel), through a Phase 3b trial targeting early symptomatic and moderate presentation of Amyotrophic Lateral Sclerosis (ALS). The trial's dual-part design, including a randomized placebo-controlled phase followed by an open-label extension, aims to establish both efficacy and safety. If successful, NurOwn could capture a significant share of the ALS treatment market, which is currently limited in options. The competitive landscape includes other therapies in development, but few focus on stem cell-based approaches. The trial's outcomes will be critical for investor confidence and potential partnerships, especially given the unmet medical need in ALS.
Indication: Amyotrophic Lateral Sclerosis (ALS)
Modality: protein therapy
Target: Mesenchymal stem cells (MSC) secreting neurotrophic factors (NTFs) aimed at delivering therapeutic agents directly to the site of damage in ALS patients.
Sponsor: Brainstorm-Cell Therapeutics
Source URL: ClinicalTrials.gov
Source updated: Detailed source ingestion pending
Ingested: Jul 11, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by target_normalized: Mesenchymal stem cells (MSC) secreting neurotrophic factors (NTFs) aimed at delivering therapeutic agents directly to the site of damage in ALS patients.
View original source fields
Condition raw: Amyotrophic Lateral Sclerosis (ALS), Amyotrophic Lateral Sclerosis
Condition normalized: Amyotrophic Lateral Sclerosis (ALS), Amyotrophic Lateral Sclerosis
Modality raw: protein therapy
Modality normalized: protein therapy
Target raw: Mesenchymal stem cells (MSC) secreting neurotrophic factors (NTFs) aimed at delivering therapeutic agents directly to the site of damage in ALS patients.
Target normalized: Mesenchymal stem cells (MSC) secreting neurotrophic factors (NTFs) aimed at delivering therapeutic agents directly to the site of damage in ALS patients.