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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: 31 Oct 2025

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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

  • 09 Sep 2025 According to a Capricor Therapeutics media release, company is awaiting the official minutes from our recent Type A meeting with the FDA review team, expected to be issued later this quarter, which will help define the next steps in our regulatory pathway.
  • 09 Sep 2025 According to a Capricor Therapeutics media release, company issued a statement regarding the U.S. Food and Drug Administration (FDA) public posting of its Complete Response Letter (CRL) for the Biologics License Application (BLA) for Deramiocel. The Company was not notified in advance that the CRL would be posted, but acknowledges the FDAs decision to publish the letter.
  • 29 Jul 2025 According to a Capricor Therapeutics media release, company will host a webinar in collaboration with Parent Project Muscular Dystrophy (PPMD) to review the current status of Biologics License Application (BLA) for Deramiocel, the webinar will be held on Tuesday, July 29, 2025, at 1:00 p.m. ET.

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