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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)

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Trial Profile

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)

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 30 May 2025

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At a glance

  • Drugs Debamestrocel (Primary)
  • Indications Amyotrophic lateral sclerosis
  • Focus Registrational; Therapeutic Use
  • Acronyms ENDURANCE STUDY
  • Sponsors Brainstorm Cell Therapeutics

Most Recent Events

  • 22 May 2025 Status changed from planning to not yet recruiting.
  • 19 May 2025 According to Brainstorm Cell Therapeutics media release, company announced that the U.S. Food and Drug Administration (FDA) has cleared the company to initiate its Phase 3b clinical trial of NurOwn (autologous MSC-NTF cells) for the treatment of amyotrophic lateral sclerosis (ALS).
  • 10 Apr 2025 According to Brainstorm Cell Therapeutics media release, company today the submission of an Investigational New Drug (IND) amendment to the U.S. Food and Drug Administration (FDA) for NurOwn.

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