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Trial of Cell Based Therapy for Duchenne Muscular Dystrophy

This study is testing a new cell therapy called MyoPAXon for Duchenne Muscular Dystrophy (DMD). MyoPAXon is made from special muscle cells. You would also receive Tacrolimus, a medicine commonly used to prevent the body from rejecting new cells. The main goal of this study is to find the highest safe dose of MyoPAXon. This study is for men aged 18 or older who have DMD, are no longer able to walk, and have specific muscles (extensor digitorum brevis, or EDB) that are still working. This study is currently unclear about its recruitment status and plans to enroll 8 participants.

Study design
This is a single-center study, meaning it takes place at one location. It is a single-arm study, so all participants will receive the same treatment. The study plans to enroll 8 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary goal of the study is measured at 3 months, but the full follow-up duration is not specified.

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NCT06692426

Trial of Cell Based Therapy for DMD

Recruiting
PHASE1Ages 18+InterventionalTreatment
Masonic Cancer Center, University of Minnesota
~8 participants
Updated 2026-03-04 on ClinicalTrials.gov
What's tested:MyoPAXonTacrolimus

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximal tolerable dose (MTD) of MyoPAXon
Measured over 3 months

Conditions

Duchenne Muscular Dystrophy

Explore related trials

Duchenne Muscular DystrophyDMD GeneDystrophin

Where it's being run

1 sites across 1 states
Minnesota1

Who to contact

Peter Kang, MD
[email protected]
612-624-9452
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Presence of HLA antibodies directed toward HLA antigens on MyoPAXon
Active treatment with another investigational therapy
Known allergy to MyoPAXon components

What this trial measures

  • Maximal tolerable dose (MTD) of MyoPAXon3 months

    Maximal tolerable dose (MTD) of MyoPAXon