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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Human Allogeneic Cardiosphere-Derived Cells for the Treatment of Duchenne Muscular Dystrophy

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Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Human Allogeneic Cardiosphere-Derived Cells for the Treatment of Duchenne Muscular Dystrophy

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 30 Sep 2024

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At a glance

  • Drugs Deramiocel (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Registrational; Therapeutic Use
  • Acronyms HOPE-3
  • Sponsors Capricor Therapeutics

    • Most Recent Events

    • 24 Sep 2024 According to a Capricor Therapeutics media release, the company will discuss the updates about the label expansion and HOPE-2 and HOPE-3 studies, in a conference call and webcast at 8:30 a.m. ET on 24 Sep 2024.
    • 24 Sep 2024 According to a Capricor Therapeutics media release, the company plans to combine Cohorts A and B of this trial to serve as a post-approval study and does not intend to unblind Cohort A at this time, which was expected to occur in the fourth quarter of 2024, in order to support potential label expansion to treat DMD skeletal muscle myopathy.
    • 07 Aug 2024 According to a Capricor Therapeutics media release, company announced the completion of a positive pre-BLA meeting with FDA that occurred in Q3 2024, where company discussed rolling BLA submission schedule, potential label expansion, plans for commercial manufacturing. Company plans to announce the outcome from pre-BLA meeting in the third quarter of 2024.

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