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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: 25 Nov 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

    • 20 Nov 2024 According to a Capricor Therapeutics media release, company announced that it had initiated its rolling Biologics License Application (BLA) submission process with the U.S. FDA seeking full approval of deramiocel to treat all patients diagnosed with DMD-cardiomyopathy. Capricor expects to complete its full BLA submission by the end of 2024.
    • 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.

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