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A Study of Deramiocel (CAP-1002) in Ambulatory and Non-Ambulatory Patients With Duchenne Muscular Dystrophy
NCT05126758 · View on ClinicalTrials.gov ↗
Study Summary
HOPE-3 is a two cohort, Phase 3, multi-center, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of a cell therapy called deramiocel (CAP-1002) in study participants with Duchenne muscular dystrophy (DMD) and impaired skeletal muscle function. Non-ambulatory and ambulatory boys and young men who meet eligibility criteria will be randomly assigned to receive either deramiocel or placebo every 3 months for a total of 4 doses during the first 12 months of the study. All participants will be eligible to receive 4 doses of deramiocel for an additional 12 months as part of an open-label extended assessment period. After completion of the first open-label extension (Months 12-24), subjects who have completed Month 24 are eligible to continue onto a Long-Term Open-Label Extension period that will provide treatment with deramiocel until commercial availability, or until sponsor's decision to terminate the trial, or the participant withdraws consent.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Deramiocel (CAP-1002)
Study Locations (20)
California
- UCSD Altman Clinical and Translational Research Institute — La Jolla
- Children's Hospital of Los Angeles, Division of Neurology — Los Angeles
- University of California, Davis — Sacramento
Missouri
- University of Missouri Health Care — Columbia
- Saint Louis Children's Hospital — St Louis
Ohio
- Akron Children's Hospital — Akron
- Cincinnati Children's Hospital Medical Center — Cincinnati
Arizona
- Phoenix Children's Hospital — Phoenix
Arkansas
- Arkansas Children's Hospital — Little Rock
Colorado
- Children's Hospital Colorado — Aurora
Georgia
- Rare Disease Research, LLC — Atlanta
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2022-06-22 |
| Est. Completion | 2026-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05126758
The ClinicalTrials.gov registry entry for NCT05126758 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Capricor, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 8 conditions, with Nervous System Diseases appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05126758 reports 20 study locations spanning 16 distinct geographic areas — top geographies include California, Missouri, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05126758 about?
NCT05126758 is a clinical study titled "A Study of Deramiocel (CAP-1002) in Ambulatory and Non-Ambulatory Patients With Duchenne Muscular Dystrophy". HOPE-3 is a two cohort, Phase 3, multi-center, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of a cell therapy called deramiocel (CAP-1002) in study participants with Duchenne muscular dystrophy (DMD) and impaired skeletal muscle function. Non-ambulat...
What is the current status of trial NCT05126758?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 106 participants. The study started on 2022-06-22. Estimated completion is 2026-12.
What conditions does trial NCT05126758 study?
This clinical trial studies the following conditions: Nervous System Diseases, Neuromuscular Diseases, Muscular Dystrophies, Muscular Diseases, Genetic Diseases, Inborn. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05126758?
The interventions under investigation include: Placebo (BIOLOGICAL), Deramiocel (CAP-1002) (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05126758?
This trial is sponsored by Capricor, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05126758 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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