CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 8 enrolled
Drug / intervention
Allogeneic Cardiosphere-Derived Cells (CAP-1002)biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06304064
NCT06304064Phase 2Completed
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Open-Label Extension of the Halt Cardiomyopathy Progression in Duchenne (HOPE-Duchenne) Trial (CAP-1002-DMD-03)

Capricor Inc.·interventional·Posted Mar 12, 2024·Updated Apr 24, 2024

In Brief

A Phase 2 clinical trial evaluating Allogeneic Cardiosphere-Derived Cells (CAP-1002) for Duchenne Muscular Dystrophy. Completed, enrolled 8 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDuchenne Muscular Dystrophy
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMar 12, 2024
Enrollment StartJun 21, 2018
Primary CompletionMar 6, 2019
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 2.3 years ago

Interventions

Allogeneic Cardiosphere-Derived Cells (CAP-1002)biological

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