NCT06304064

Halt cardiomyOPathy progrEssion in Duchenne (HOPE-OLE)

Open-Label Extension of the Halt Cardiomyopathy Progression in Duchenne (HOPE-Duchenne) Trial (CAP-1002-DMD-03)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Capricor Inc. · Industry
• Sex: Male
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This Phase 2, multi-center, open-label extension trial will provide CAP-1002 to participants who were randomized to the Usual Care treatment group of the HOPE-Duchenne study (NCT02485938) and completed 12 months of follow-up. The trial will assess the safety and efficacy of two intravenous administrations of CAP-1002, each separated by three months.

Detailed description

Participants with documented enrollment in the Usual Care treatment group of the HOPE-Duchenne study and completion of study follow-up through Month 12 were eligible for this study. Participants 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 CAP-1002. All CAP-1002 infusions will be conducted in an outpatient setting at the investigative site on Day 1 and at Month 3. Participants 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.

Conditions

• Duchenne Muscular Dystrophy

Interventions

Type	Name	Description
BIOLOGICAL	Allogeneic Cardiosphere-Derived Cells (CAP-1002)	Intravenous infusion delivery of Allogeneic Cardiosphere-Derived Cells (CAP-1002; 75 million CDCs)

Timeline

• Start date: 2018-06-21
• Primary completion: 2019-03-06
• Completion: 2019-03-06
• First posted: 2024-03-12
• Last updated: 2024-04-24
• Results posted: 2024-04-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study