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Halt cardiomyOPathy progrEssion in Duchenne (HOPE-OLE)

NCT06304064 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-04-24

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Allogeneic Cardiosphere-Derived Cells (CAP-1002)

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

Sponsors & Collaborators

  • Capricor Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Awadalla · Capricor Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-21
Primary Completion
2019-03-06
Completion
2019-03-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06304064 on ClinicalTrials.gov