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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Intravenous Delivery of Allogeneic Cardiosphere-Derived Cells in Subjects With Duchenne Muscular Dystrophy

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Trial Profile

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Intravenous Delivery of Allogeneic Cardiosphere-Derived Cells in Subjects With Duchenne Muscular Dystrophy

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 09 Oct 2024

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At a glance

  • Drugs Deramiocel (Primary)
  • Indications Duchenne muscular dystrophy
  • Focus Registrational; Therapeutic Use
  • Acronyms HOPE-2
  • Sponsors Capricor Therapeutics

    • Most Recent Events

    • 04 Oct 2024 According to a Capricor Therapeutics media release, company will present the three-year safety and efficacy results as poster presentation at the 29th Annual Congress of the World Muscle Society (WMS 2024), taking place October 8-12, 2024, in Prague, Czechia.
    • 24 Sep 2024 According to a Capricor Therapeutics media release, the company will discuss the updates about the BLA 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 has announced an intent to file BLA for the full approval of Deramiocel of DMD Cardiomyopathy, following recent meetings with the USFDA, based on existing positive cardiac and natural history data from the Phase 2 HOPE-2 and HOPE-2 Open Label Extension (OLE) trials, as discussed with FDA. Filing is expected in October 2024 and full submission is expected by year-end 2024.

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