NCT06692426 Trial of Cell Based Therapy for DMD
| NCT ID | NCT06692426 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Masonic Cancer Center, University of Minnesota |
| Condition | Duchenne Muscular Dystrophy |
| Study Type | INTERVENTIONAL |
| Enrollment | 8 participants |
| Start Date | 2025-03-20 |
| Primary Completion | 2027-03-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 8 participants in total. It began in 2025-03-20 with a primary completion date of 2027-03-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a single-center, single-arm, interventional phase 1 trial to evaluate the safety and tolerability of local injection of induced pluripotent stem cell (iPSC)- derived CD54+ allogeneic muscle progenitor cells in individuals with Duchenne muscular dystrophy (DMD)
Eligibility Criteria
Inclusion Criteria: * Duchenne muscular dystrophy, diagnosed by mutations in the DMD (dystrophin) gene and/or absence of immunohistochemical staining for dystrophin on muscle biopsy * Non-ambulatory * Intact extensor digitorum brevis (EDB) muscles bilaterally * Off investigational therapies for \> 30 days * Age 18 years of age or older at the time of consent * Have adequate organ function confirmed by the following laboratory values obtained within 14 days prior to enrollment (28 days for cardiac and pulmonary function): * Participants with partners of childbearing potential must be willing to use at least two forms of effective birth control (one form must be a barrier method) while receiving the study product and for 3 months after stopping tacrolimus therapy. * Ability to follow commands sufficiently to perform voluntary aspects of outcome measures throughout the study period * Willing to consent to monitoring for 15 years, including an extension period, as required for all interventional studies involving the transplantation of cells that have been genetically modified * Voluntary written consent from the subject or parent(s)/guardian(s) and assent from participant prior to the performance of any research related activity. Exclusion Criteria: * Presence of HLA antibodies directed toward HLA antigens on MyoPAXon * Active treatment with another investigational therapy * Known allergy to MyoPAXon components
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06692426 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Duchenne Muscular Dystrophy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06692426 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06692426 currently recruiting?
Yes, NCT06692426 is actively recruiting participants. Contact the research team at mdstemcell@umn.edu for enrollment information.
Where is the NCT06692426 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT06692426 clinical trial?
NCT06692426 is sponsored by Masonic Cancer Center, University of Minnesota. The trial plans to enroll 8 participants.