HOPE Phase I/II
The Halt cardiomyOPathy progrEssion in Duchenne (HOPE) Phase I/II trial will evaluate CAP-1002 in patients with Duchenne Muscular Dystrophy associated cardiomyopathy.
The HOPE-DUCHENNE trial will evaluate CAP-1002 for the first time in boys with Duchenne Muscular Dystrophy who have significant cardiac involvement. Cardiomyopathy is currently the leading cause of death in patients with DMD, having recently supplanted respiratory causes as a result of treatment improvements for that aspect of the disease. Subjects will receive CAP-1002 in all three coronary arteries using the same non-stop flow technique as in the DYNAMIC trial. The first 6 subjects randomized will be 18 years or older. Pending a safety review the trial will then be open to subjects ≥ 12 years of age.
The Phase I/II HOPE-DUCHENNE trial is designed as a randomized open-label usual care controlled multi-center study evaluating the safety and preliminary efficacy of CAP-1002 in up to 24 subjects.
Male subjects with cardiomyopathy secondary to Duchenne muscular dystrophy, with left ventricular scar involving at least 4 cardiac segments and ejection fraction ≥ 35%;
Please visit ClinicalTrials.gov for more information regarding the HOPE clinical trial.