Actively Recruiting
Administration of Allogeneic-MSC in Patients With Non-Ischemic Dilated Cardiomyopathy
Led by Joshua M Hare · Updated on 2026-03-24
136
Participants Needed
4
Research Sites
307 weeks
Total Duration
On this page
Sponsors
J
Joshua M Hare
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the safety and effectiveness of an experimental drug called human allogeneic mesenchymal stem cell therapy.
CONDITIONS
Official Title
Administration of Allogeneic-MSC in Patients With Non-Ischemic Dilated Cardiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 to 80 years (inclusive) at the time of signing the informed consent form.
- Diagnosis of non-ischemic dilated cardiomyopathy with left ventricular ejection fraction 45%.
- On appropriate guideline-directed optimal medical therapy for non-ischemic cardiomyopathy, including beta blockers and ACE inhibitors or ARBs or ARNI, or have a medical reason preventing use of these, with a stable regimen for at least 30 days prior.
- Candidate for cardiac catheterization.
- Willing to undergo DNA testing.
You will not qualify if you...
- Eligible for or requiring surgical or percutaneous intervention for non-ischemic dilated cardiomyopathy.
- Clinical signs or history of coronary artery disease or prior coronary interventions.
- Epicardial stenosis of 70% or greater in major coronary arteries.
- Valvular heart disease including certain prostheses and severe aortic valve insufficiency/regurgitation within 12 months.
- Aortic stenosis with valve area 1.5 cm2.
- Cardiomyopathy due to acute postpartum (within 6 months), non-compaction, hypertrophic, or known toxin causes (except anthracycline-induced).
- QTc interval greater than 550 ms on baseline ECG.
- Recent appropriate firing of implantable cardioverter defibrillator or pacing within 30 days.
- Baseline kidney function below site cutoff.
- Blood abnormalities including low hemoglobin, hematocrit, neutrophils, or platelets.
- Liver dysfunction with enzyme levels greater than three times normal.
- Bleeding disorders or inability to stop anticoagulation therapy.
- Solid organ transplant recipients (excluding certain cell-based therapies or grafts).
- History of transplant rejection.
- Malignancy within past 12 months except certain skin or cervical cancers.
- Drug or alcohol abuse within past 9 months.
- Positive for HIV, hepatitis B, or viremic hepatitis C.
- Known left ventricular thrombus, aortic dissection, or aneurysm.
- Blood glucose (HbA1c) above 10%.
- Severe allergy to radiographic contrast.
- Known anaphylactic reactions to penicillin or streptomycin.
- Hypersensitivity to dimethyl sulfoxide (DMSO).
- Non-cardiac condition with life expectancy under 1 year.
- Stroke or transient ischemic attack within 3 months.
- Pregnant, nursing, or of childbearing potential without contraception.
- Pacemaker-dependent with ICD, or pacemaker/ICD with specific device limitations.
- Cardiac resynchronization therapy device implanted less than 3 months ago.
- Other MRI contraindications.
- Need for advanced heart failure therapy.
- Participation in another investigational trial within 30 days.
- Any condition deemed a contraindication by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Stanford University
Stanford, California, United States, 94304
Actively Recruiting
2
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Actively Recruiting
3
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
4
Texas Heart Institute
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Shelly L Sayre, MPH
CONTACT
L
Lina Caceres
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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