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Hope for duchenne: new cell therapy shows promise in Long-Term trial

NCT ID NCT04428476

Disease control Sponsor: Capricor Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests the long-term safety and effectiveness of a cell therapy called deramiocel (CAP-1002) in people with Duchenne muscular dystrophy who completed the earlier HOPE-2 trial. Participants receive an infusion of deramiocel every 3 months for about 5 years, with the option to continue until the drug is available commercially. The goal is to see if regular treatment can help maintain upper limb function and keep side effects manageable.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

13 people

The number who actually took part.

Started

Aug 2020

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Documented enrollment in the HOPE-2 trial and completion of trial follow-up through Month 12 2. 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 3. Adequate venous access for intravenous deramiocel (CAP-1002) infusions in the judgement of the Investigator 4. Assessed by the Investigator as willing and able to comply with the requirements of the trial Exclusion Criteria: 1. Planned or likely major surgery in the next 12 months after planned first infusion 2. 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 3. History of non DMD-related chronic respiratory disease including, but not limited to, asthma, bronchitis, and tuberculosis 4. Acute respiratory illness within 60 days prior to first infusion 5. Known hypersensitivity to dimethyl sulfoxide (DMSO) or bovine products 6. Treatment with an investigational product ≤ 6 months prior to first infusion 7. History, or current use, of drugs or alcohol that could impair ability to comply with participation in the trial 8. Inability to comply with the investigational plan and follow-up visit schedule for any reason, in the judgment of the investigator

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Conditions

The condition(s) this trial relates to.

Duchenne muscular dystrophy muscular dystrophy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Duchenne muscular dystrophy

Contacts and locations

Locations

  • Children's Hospital Colorado

    Aurora, Colorado, 80045, United States

  • Children's Hospital Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229, United States

  • University of California, Davis

    Sacramento, California, 95817, United States

  • Washington University

    St Louis, Missouri, 63110, United States

More trials for these conditions

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