Therapeutic Candidate or Device

Allogeneic Cardiosphere-Derived Cells (CDCs, CAP-1002)

Indication

Duchenne Muscular Dystrophy Cardiomyopathy

Therapeutic Mechanism

Secretion of identified bioactive elements will reduce myocardial fibrosis and improve cardiac function.

Unmet Medical Need

Heart failure is the leading cause of death among young men with Duchenne Muscular Dystrophy. No specific therapies exist to treat this element of the disease. CAP-1002 is intended to treat the cardiomyopathy associated with DMD.

Project Objective

Phase 2 study completed

Major Proposed Activities

• manufacture CAP-1002 in quantities sufficient to treat all subjects enrolled in the trial
• enroll and treat all subjects per the clinical protocol
• enroll and treat all subjects per the clinical protocol

The applicant is a California-based organization. At least one clinical site within California will participate in the study.