Status:
ACTIVE_NOT_RECRUITING
Open-label Extension of the HOPE-2 Trial
Lead Sponsor:
Capricor Inc.
Conditions:
Duchenne Muscular Dystrophy
Eligibility:
All Genders
10+ years
Phase:
PHASE2
Brief Summary
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 explor...
Detailed Description
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 explor...
Eligibility Criteria
Inclusion
- Documented enrollment in the HOPE-2 trial and completion of trial follow-up through Month 12
- Willing and able to provide informed consent to participate in the trial if ≥ 18 years of age, and assent with parental or guardian informed consent if \< 18 years of age
- Adequate venous access for intravenous deramiocel (CAP-1002) infusions in the judgement of the Investigator
- Assessed by the Investigator as willing and able to comply with the requirements of the trial
Exclusion
- Planned or likely major surgery in the next 12 months after planned first infusion
- Risk of near-term respiratory decompensation in the judgment of the investigator, or the need for initiation of non-invasive ventilator support as defined by serum bicarbonate ≥ 29 mmol/L
- History of non DMD-related chronic respiratory disease including, but not limited to, asthma, bronchitis, and tuberculosis
- Acute respiratory illness within 60 days prior to first infusion
- Known hypersensitivity to dimethyl sulfoxide (DMSO) or bovine products
- Treatment with an investigational product ≤ 6 months prior to first infusion
- History, or current use, of drugs or alcohol that could impair ability to comply with participation in the trial
- Inability to comply with the investigational plan and follow-up visit schedule for any reason, in the judgment of the investigator
Key Trial Info
Start Date :
August 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2026
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04428476
Start Date
August 5 2020
End Date
May 1 2026
Last Update
November 3 2025
Active Locations (5)
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1
University of California, Davis
Sacramento, California, United States, 95817
2
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
3
Washington University
St Louis, Missouri, United States, 63110
4
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229