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.
Age range
12 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of Participants Experiencing Any of the Adjudicated Events
Timeframe: Within 72 hours post-infusion
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timeframe: Up to Month 12 post-infusion
Change From Baseline in Clinical Laboratory Parameters (Chloride, Potassium and Sodium) at Month 6 and Month 12
Timeframe: Baseline, Month 6 and Month 12
Change From Baseline in Clinical Laboratory Parameter - Albumin at Month 6 and Month 12
Timeframe: Baseline, Month 6 and Month 12
Change From Baseline in Clinical Laboratory Parameter - Glucose at Month 6 and Month 12
Timeframe: Baseline, Month 6 and Month 12
Change From Baseline in Hematological Parameters (Platelets, White Blood Cells, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils) at Month 6 and Month 12
Timeframe: Baseline, Month 6 and Month 12
Change From Baseline in Hematological Parameter - Hemoglobin at Month 6 and Month 12
Timeframe: Baseline, Month 6 and Month 12
Change From Baseline in Hematological Parameter - Red Blood Cells at Month 6 and Month 12
Timeframe: Baseline, Month 6 and Month 12
Change From Baseline in Vital Signs - Blood Pressure at Month 6 and Month 12
Timeframe: Baseline, Month 6 and Month 12
Change From Baseline in Vital Signs - Heart Rate at Month 6 and Month 12
Timeframe: Baseline, Month 6 and Month 12
Change From Baseline in Vital Signs - Respiratory Rate at Month 6 and Month 12
Timeframe: Baseline, Month 6 and Month 12
Change From Baseline in Vital Signs - Temperature at Month 6 and Month 12
Timeframe: Baseline, Month 6 and Month 12
Number of Participants With Clinically Significant Change From Baseline in Cardiac Physical Examinations at Month 6 and Month 12
Timeframe: Baseline, Month 6 and Month 12
Change From Baseline in Electrocardiogram (ECG) Parameters (QRS Duration, PR, QT, QTc and QT Interval) at Month 6 and Month 12
Timeframe: Baseline, Month 6 and Month 12
Change From Baseline in Electrocardiogram Parameter - Ventricular Rate at Month 6 and Month 12
Timeframe: Baseline, Month 6 and Month 12