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Umbilical cord stem cells aim to slow muscle loss in duchenne boys

NCT ID NCT06579352

Disease control Sponsor: MED Institute 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 21, 2026 · Last updated Aug 14, 2026 · Updated 3 times

Summary

This study tests whether stem cells from donated umbilical cords can help boys with Duchenne muscular dystrophy (DMD). The cells are given through a vein and are meant to reduce inflammation and improve muscle function. The trial includes boys aged 5 to 10 who can still walk and have stable steroid use. Researchers will track side effects and changes in movement tests and blood markers over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
human umbilical cord mesenchymal stem cells (UC-MSC) given intravenously
What this could lead to
If successful, this could point toward a treatment that slows muscle decline and improves daily function in Duchenne muscular dystrophy.
What could go wrong
This is a small, early-phase study focused on safety, so it may not show clear benefit. Stem cell treatments also carry risks like infusion reactions or unknown long-term effects.

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

About 35 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Apr 2029

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

5 to 10 years

Sex

Male participants only

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. Male sex by birth with a genetically confirmed diagnosis of Duchenne Muscular Dystrophy (DMD). 2. Age is greater than or equal to 5 and less than or equal to 10 years. 3. Has a North Star Ambulatory Assessment (NSAA) score greater than 13 and less than 30. 4. Demonstrates the ability to perform the "time to rise" test in under 10 seconds. 5. Is up-to-date on immunizations. 6. Is on a stable dose of glucocorticoids for at least 12 weeks prior to study participation, except for weight-based or toxicity-related adjustments. 7. Is on a stable dose of supplements for at least 12 weeks prior to study participation. 8. Has the ability to comply with the requirements of the study and the ability to understand and provide written informed assent and a guardian's consent. 9. Patient must be either a non-responder to or a poor candidate for treatment with another established therapy. Exclusion Criteria: 1. Active cancer or prior diagnosis of cancer within the past year (patients with basal and squamous cell cancer of the skin will not be excluded). 2. BMI \> 45 kg/m². 3. Any other condition (including concomitant treatment) that, in the judgment of the Investigator or Sponsor, would be a contraindication to enrollment, study product administration (e.g., known hypersensitivity to dimethyl sulfoxide (DMSO), Human Serum Albumin (HSA), or PlasmaLyte), or follow-up. 4. Treatment with an exon skipping therapy within 3 months of study start. 5. Cognitive delay or impairment that can confound motor development in the opinion of the investigator. 6. Major surgery within 3 months prior to Day 0 or planned surgery or procedures that could affect the conduct of the study.

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Conditions

The condition(s) this trial relates to.

Duchenne 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

  • Neurology Rare Disease Center

    Flower Mound, Texas, 75028, United States

  • Other locations - TBD

    Dallas, Texas, 75201, United States

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