Nervous System Diseases Clinical Trial
Official title:
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Intravenous Delivery of Allogeneic Cardiosphere-Derived Cells in Subjects With Duchenne Muscular Dystrophy
HOPE-2 is a double-blind clinical trial evaluating the safety and efficacy of a cell therapy called CAP-1002 in study participants with Duchenne muscular dystrophy (DMD). Non-ambulatory and ambulatory boys and young men who meet eligibility criteria will be randomly assigned to receive either CAP-1002 or placebo every 3 months for a total of 4 doses during a 12-month period.
- Approximately 84 eligible study participants will be randomized to either CAP-1002 or
placebo in a 1:1 ratio.
- The trial will include visits at Screening, Baseline/Day 1, Week 4, and Months 3, 6, 9,
and 12 with IV infusions of CAP-1002 or placebo on Day 1 and Months 3, 6, and 9.
- Safety evaluations will include adverse events, concomitant medications, physical exam,
vital signs, 12-lead ECG, and clinical laboratory testing.
- Efficacy will be evaluated in the Performance of the Upper Limb, pulmonary function
testing, North Star Ambulatory Assessment (ambulatory subjects only), strength testing,
cardiac MRI, and quality of life.
- If trial data suggests an appropriate risk/benefit profile of CAP-1002, Capricor, upon
the recommendation of the Data Safety Monitoring Board (DSMB), will introduce an
open-label extension study to offer CAP-1002 to study participants who were randomized
to placebo and completed all trial visits during the 12-month period.
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