NCT06579352Active, not recruitingPhase 2
Study of UC-MSC in DMD Patients
Study of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSC) In Patients With Duchenne Muscular Dystrophy
Source: ClinicalTrials.gov · Last updated 14 Aug 2026
Brief summary (registry, in English)
The primary objective of this study is to provide UC-MSC treatment to patients with DMD. Secondary objectives will be to further evaluate treatment-related adverse events as well as changes in DMD-related functional testing/assessments, blood laboratories, and inflammation related biomarker levels over time.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 35 (estimated)
- First submitted
- 27 Aug 2024
- Start date
- 5 Aug 2024
- Primary completion date
- 31 Oct 2028
- Lead sponsor
- MED Institute Inc.
- Diseases
- Duchenne muscular dystrophy
- NCT number
- NCT06579352
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 35
- From 5 Aug 2024 to the primary completion date, 31 Oct 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
- Treatment with an exon skipping therapy within 3 months of study start.
- Major surgery within 3 months prior to Day 0 or planned surgery or procedures that could affect the conduct of the study.
Other illness
- Cognitive delay or impairment that can confound motor development in the opinion of the investigator.
Lab values
- 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.
Other
- BMI \> 45 kg/m².
Who the study is looking for
- Male sex by birth with a genetically confirmed diagnosis of Duchenne Muscular Dystrophy (DMD).
- Age is greater than or equal to 5 and less than or equal to 10 years.
- Has a North Star Ambulatory Assessment (NSAA) score greater than 13 and less than 30.
- Demonstrates the ability to perform the "time to rise" test in under 10 seconds.
- Is up-to-date on immunizations.
- Is on a stable dose of glucocorticoids for at least 12 weeks prior to study participation, except for weight-based or toxicity-related adjustments.
- Is on a stable dose of supplements for at least 12 weeks prior to study participation.
- 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.
- Patient must be either a non-responder to or a poor candidate for treatment with another established therapy.
Age in the registry: 5 years to 10 years · Sex: Male · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Other locations - TBD Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Neurology Rare Disease Center Coordinator of this site? Confirm its status | Flower Mound | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.