drugset / Trial / NCT02485938

HOPE-Duchenne (Halt cardiomyOPathy progrEssion in Duchenne)

NCT02485938 ↗

Phase 2 Completed 25 enrolled Capricor Inc.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2016-01-07
Primary completion
2017-09-14
Completion
2017-09-14

Outcome

Met primary endpoint

release “CAP-1002 has been well-tolerated in the HOPE trial. During and immediately following CAP-1002 infusion, no treated subjects experienced a pre-specified composite safety endpoint” capricor.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Deramiocel Cell therapy 50 cells Other
Subject Deramiocel Cell therapy 75 cells Other