At a glance
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A Randomized, Open-label Study of the Safety and Efficacy of Multi- Vessel Intracoronary Delivery of Allogeneic Cardiosphere-Derived Cells in Patients With Cardiomyopathy Secondary to Duchenne Muscular Dystrophy
In Brief
A Phase 2 clinical trial evaluating Allogeneic Cardiosphere-Derived Cells (CAP-1002) for Duchenne Muscular Dystrophy and Cardiomyopathy. Completed, enrolled 25 participants across 3 sites.
Detailed Summary
Male participants with cardiomyopathy secondary to Duchenne muscular dystrophy (DMD) meeting all inclusion and no exclusion criteria will be randomized. All participants will be at least 12 years of age. They will be randomized in a 1:1 manner to either intracoronary infusion of CAP-1002 in three coronary arteries supplying the three major cardiac territories of the left ventricle of the heart (anterior, lateral, inferior/posterior) or usual care. In the active treatment arm, all three major cardiac territories will be treated (infused) during a single procedure in an open-label fashion.
Study Details
Timeline
Interventions
Intracoronary delivery of Allogeneic Cardiosphere-Derived Cells (CAP-1002)