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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: 18 Aug 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

  • 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.
  • 14 Jul 2025 According to a Capricor Therapeutics media release, the company has received a Complete Response Letter (CRL) from the USFDA for its BLA filed for CAP-1002 (deramiocel) in Duchenne Muscular Dystrophy (DMD) cardiomyopathy. CRLs are issued directly to product sponsors when the FDA completes its review cycle and determines that it cannot grant an approval of an application in its current form.
  • 11 Jul 2025 According to a Capricor Therapeutics media release, plans to resubmit its BLA to include data from the ongoing Phase 3 HOPE-3 trial in Q3 2025 to continue pursuing the indication for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy.

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