Trial of Cell Based Therapy for DMD
Recruiting now · Phase 1
Conditions studied: Duchenne Muscular Dystrophy
In brief
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)
Key facts
- Study ID
- NCT06692426
- Run by
- Masonic Cancer Center, University of Minnesota
- People needed
- 8
- Starts
- 2025-03-20
- Expected to finish
- 2027-03-03
- Last updated by the study team
- 2026-03-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Presence of HLA antibodies directed toward HLA antigens on MyoPAXon
- Active treatment with another investigational therapy
- Known allergy to MyoPAXon components
Where it is running
- Masonic Cancer Center — Minneapolis, Minnesota, United States (enrolling)
Full record on ClinicalTrials.gov
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