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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: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Sep 2026

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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

  • 17 Sep 2026 According to a Capricor Therapeutics media release, data from HOPE-3 and its open-label extension (OLE) of Deramiocel, for the treatment of Duchenne muscular dystrophy (DMD), will be presented in a late-breaking poster and an oral presentation at the 31st Annual Congress of the World Muscle Society (WMS 2026), taking place September 29 - October 3, 2026, in Hiroshima, Japan.
  • 28 Aug 2026 Planned End Date changed from 1 Dec 2026 to 1 Mar 2027.
  • 24 Aug 2026 As part of its ongoing discussions with the FDA following the July 2026 Advisory Committee meeting, Capricor submitted an amendment to the BLA that includes 24-month open-label extension data from its pivotal Phase 3 HOPE-3 study and additional robustness analyses, with a request that the FDA review the existing and new data in support of a refined proposed indication focused on upper limb function, the primary endpoint of HOPE-3. The FDA's (CBER) accepted the amendment for review.

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