CAP-1002 for Duchenne Muscular Dystrophy
(HOPE-2-OLE Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
How is the drug CAP-1002 different from other treatments for Duchenne Muscular Dystrophy?
What is the purpose of this trial?
This Phase 2, multi-center, open-label extension trial will provide deramiocel (CAP-1002) to subjects that were enrolled in the HOPE-2 trial and completed 12 months of follow-up. The trial will explore the safety and efficacy of twenty intravenous administrations of deramiocel, each separated by three months. Subjects will undergo a targeted screening during a 30-day screening period, eligible subjects will then undergo baseline safety and efficacy assessments on Day 1 prior to their first infusion of deramiocel.Subjects will complete trial assessments at Screening; Day 1; Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, and 60. Safety and efficacy assessments will be conducted prior to deramiocel administration at the Day 1, Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, and 57 trial visits, unless otherwise indicated.All deramiocel infusions will be conducted in an outpatient setting at the investigative site on Day 1 and Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, and 57. Subjects will be observed in the outpatient setting for at least two hours post infusion and then discharged the same day, if medically cleared by the site Investigator.
Research Team
Craig McDonald, MD
Principal Investigator
UC Davis
Mark Awadalla
Principal Investigator
Capricor Inc.
Eligibility Criteria
This trial is for those who were in the HOPE-2 study, finished a year of follow-up, and can give consent. They must have good veins for infusions and be able to stick to the trial plan. People with planned major surgery, recent investigational drug use, substance abuse issues, or severe respiratory problems can't join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 20 intravenous infusions of deramiocel, each separated by three months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- CAP-1002
Find a Clinic Near You
Who Is Running the Clinical Trial?
Capricor Inc.
Lead Sponsor