A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL EVALUATING THE EFFICACY AND SAFETY OF HUMAN ALLOGENEIC CARDIOSPHERE-DERIVED CELLS FOR THE TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (HOPE-3)

eligible subjects will be randomized to CaP-1002 or Placebo. This two Cohort, Phase 3, multi-center, randomized, double-blind, 12-month placebo-controlled trial, will assess the efficacy and safety of human allogeneic CDCs (CaP-1002). Cohort a x 1:1 (active: Placebo) 12-Month placebo-controlled cohort where CaP-1002a (Capricor Manufacturing Facility in Los angeles, Ca) or placebo will be administered as 4 iV infusions, once every 3 months, for the treatment of subjects with Duchenne muscular dystrophy. after completion of the initial 4 iV infusions, all study subjects will be eligible to receive up to 4 additional iV infusions of CaP-1002 (CaP-1002a or upon availability, CaP-1002B [Capricor Manufacturing Facility in San Diego, Ca]) once every 3 months in a 12-month open-label extended assessment period (the oLe phase). Cohort B x 1:1 (active: Placebo) 12-Month placebo-controlled cohort where CaP-1002B (Capricor Manufacturing Facility in San Diego, Ca) or placebo will be administered 4 intravenous (iV) infusions, once every 3 months, for the treatment of subjects with Duchenne muscular dystrophy. all subjects will be eligible to continue to receive CaP-1002B once every 3 months in a subsequent 12-month open-label extended assessment period (the oLe phase). The study hypothesis is that patients with DMD who enroll into this study and receive active treatment with CaP-1002, will show superior upper extremity muscle function compared to those receiving placebo at the 12-month timepoints as measured by the PuL 2.0.