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A Phase 3, Randomized Double-Blind, Placebo-Controlled Multicenter Study to Evaluate Efficacy and Safety of Repeated Administration of NurOwn (Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors) in Participants With ALS

Trial Profile

A Phase 3, Randomized Double-Blind, Placebo-Controlled Multicenter Study to Evaluate Efficacy and Safety of Repeated Administration of NurOwn (Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors) in Participants With ALS

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Mar 2024

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At a glance

  • Drugs Neurotrophic factor producing mesenchymal stem cell therapy BrainStorm Cell therapeutics (Primary)
  • Indications Amyotrophic lateral sclerosis
  • Focus Adverse reactions; Biomarker; Registrational; Therapeutic Use
  • Sponsors Brainstorm Cell Therapeutics
  • Most Recent Events

    • 17 Nov 2023 According to a Brainstorm media release, new analyses from this trial will be presented at the 6th Annual ALS Research Symposium hosted by ALS ONE.
    • 27 Sep 2023 According to a Brainstorm media release, announced the outcome of the U.S. Food and Drug Administration's Cellular, Tissue and Gene Therapies Advisory Committee meeting to review the Biologics License Application (BLA) for NurOwn. The the Committee voted that NurOwn did not demonstrate substantial evidence of effectiveness for treatment of mild to moderate ALS.
    • 12 Jul 2023 According to a Brainstorm media release, FDA will hold an Advisory Committee meeting for the ALS indication on September 27, 2023, with a PDUFA target action date of December 8, 2023.
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