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: 06 Feb 2025

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At a glance

04 Feb 2025 Planned End Date changed from 1 Dec 2026 to 1 Dec 2027.
04 Feb 2025 Planned primary completion date changed from 1 Dec 2024 to 1 Dec 2025.
02 Jan 2025 According to a Capricor Therapeutics media release, company announced the completion of the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking full approval for deramiocel to treat patients diagnosed with Duchenne muscular dystrophy (DMD) cardiomyopathy supported by data from its Phase 2 HOPE-2 and HOPE-2 Open Label Extension (OLE) trials.

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