Capricor Deramiocel (CAP-1002) HOPE-2-OLE Clinical Trial for Duchenne muscular dystrophy

Active, Not RecruitingPhase 2Improving Muscle Growth & Protection

Age: 10 years and older
Phase: Phase 2
Sponsor: Capricor
Therapeutic Approach: Improving Muscle Growth & Protection
Variant Requirement: Documented enrollment in the HOPE-2 trial and completion of trial follow-up through Month 12.
Eligible Sex: Male
Ambulation: Ambulatory and Non-Ambulatory
Study Start (Actual): 2020-08-05
Primary Completion (Estimated): 2022-02-16
Study Completion (Estimated): 2026-05
Enrollment (Estimated): 13
Countries: United States

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

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

NCT ID

This information is provided for educational purposes only. Always consult the study investigators before making medical decisions.

Study Requirements and Criteria