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

Not yet provided

• 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