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SRD-001 Gene Therapy for Duchenne Muscular Dystrophy Cardiomyopathy

This study is testing an experimental gene therapy called SRD-001 for men aged 18 and older with Duchenne muscular dystrophy (DMD) who also have a weakened heart (cardiomyopathy). SRD-001 aims to help your heart muscle cells pump better by providing extra copies of a gene called SERCA2a. Researchers want to see if SRD-001 is safe and if it improves heart function. You would continue taking your current heart medications. The study is looking at how many people pass away, and the number and seriousness of any side effects. This study is currently unclear about its recruitment status.

Study design
This is a Phase 1b, multi-center, open-label study with 12 participants. It is not randomized and includes a no-intervention control group.
What's involved
If you receive SRD-001, you will have a cardiac catheterization and angiography, followed by an overnight hospital stay for observation.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and side effects for up to 104 weeks (about 2 years) after the treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06224660

Modulation of SERCA2a of Intra-Myocytic Calcium Trafficking in Cardiomyopathy Secondary to Duchenne Muscular Dystrophy

Recruiting
PHASE1Ages 18+InterventionalTreatment
Sardocor Corp.
~12 participants
Updated 2025-02-27 on ClinicalTrials.gov
What's tested:SRD-001

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of all-cause mortality
Measured over From Day 1 to Week 52 and Week 104
+3 more outcomes measured

Conditions

DMD-Associated Dilated Cardiomyopathy

Explore related trials

Dilated CardiomyopathyDuchenne Muscular Dystrophy

Where it's being run

3 sites across 2 states
Ohio2
Kansas1

Who to contact

Sardocor Corp.
[email protected]
+1-617-880-7616
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Diagnosis of DMD with confirmatory genetic testing
Cardiomyopathy with left ventricular scar in at least 3 of 16 segments
Left ventricular ejection fraction \< 40%
Individualized, optimized cardiac medical therapy and glucocorticoid treatment for at least 12 months prior to enrollment
Willing and able to provide informed consent

Exclusion

Abnormal blood pressure
Non-DMD-related liver function test elevations
Cystatin C ≥ 1.2 mg/L
Thrombocytopenia
Anemia
Inadequate pulmonary function

What this trial measures

  • Rate of all-cause mortalityFrom Day 1 to Week 52 and Week 104

    Death

  • Rate and severity of related treatment-emergent adverse eventsFrom Day 1 to Week 52 and Week 104

    Adverse events related to the investigational product or the administration procedure

  • Rate and severity of all treatment-emergent adverse eventsFrom Day 1 to Week 52 and Week 104

    Adverse events

  • Rate of cell-mediated immune reactionFrom Day 1 to Week 52

    Cell-mediated immune reaction as assessed by enzyme-linked immunosorbent spot (ELISpot)