Administration of Allogeneic-MSC in Patients With Non-Ischemic Dilated Cardiomyopathy

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Non-ischemic Dilated Cardiomyopathy

In brief

The purpose of this study is to evaluate the safety and effectiveness of an experimental drug called human allogeneic mesenchymal stem cell therapy.

Key facts

Study ID: NCT04476901
Run by: Joshua M Hare
People needed: 136
Starts: 2021-05-07
Expected to finish: 2027-04-01
Last updated by the study team: 2026-03-24

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Men and women aged 18 to 80 years (inclusive) at the time of signing the informed consent form.
Diagnosis of NIDCM with left ventricular ejection fraction ≤45%.
Appropriate guideline-directed optimal medical therapy for non-ischemic cardiomyopathy. At a minimum, subjects must be on beta blockers and angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) or Angiotensin Receptor Neprilysin Inhibitors (ARNI) or have appropriate medical indication precluding use of one or both of these agents. Subjects must be on a stable regimen for at least 30 days prior to the procedure. Dose titration is allowed.
Be a candidate for cardiac catheterization*
Be willing to undergo DNA test.

You may not qualify if…

An individual who meets any of the following criteria will be excluded from participation in this study:
Be eligible for or require standard-of-care surgical or percutaneous intervention for the treatment of non-ischemic dilated cardiomyopathy
Clinical manifestation of coronary artery disease (CAD) (e.g., chest pain and concomitant clinical findings such as electrocardiogram changes suggestive of coronary ischemia, myocardial infarction) or evidence of endocardial or transmural scar on cardiac MRI suggestive of undiagnosed CAD or history of percutaneous coronary intervention (PCI) or coronary artery bypass surgery (CABG). Be indicated for or require coronary artery revascularization
Documented presence of epicardial stenosis of 70% or greater in one or more major epicardial coronary arteries
Valvular heart disease including 1) aortic valve prosthesis, mechanical mitral valve, and mitral valve clip; 2) severe aortic valve insufficiency/regurgitation within 12 months of consent*
Aortic stenosis with valve area ≤ 1.5cm2*
Cardiomyopathy due to acute Post-partum (within 6 months), Non-compaction*, or Hypertrophic* cardiomyopathy
Cardiomyopathy due to known toxin (e.g amyloid) Note: anthracycline induced cardiomyopathy will be allowed
QTc interval > 550 ms on baseline electrocardiogram (ECG) (note: QTc interval is the interval between the start of the Q wave and the end of the T wave in the heart's electrical cycle)
Automated Implantable Cardioverter Defibrillator (AICD) appropriate firing or anti tachycardia pacing for ventricular tachycardia or ventricular fibrillation within 30 days prior to consent
Have an estimated baseline glomerular filtration rate below the clinical site's institutional cutoff
A hematologic abnormality during baseline testing as evidenced by hemoglobin < 9 g/dl; hematocrit < 30%; absolute neutrophil count < 2,000 or total WBC count more than 2 times upper limit of normal; or platelet values < 100,000/ul
Have liver dysfunction, as evidenced by enzymes Aspartate Transaminase Enzyme (AST) and Alanine Aminotransferase Enzyme (ALT) greater than three times the ULN
Have a bleeding diathesis or coagulopathy (International Normalised Ratio (INR) > 1.5), cannot be withdrawn from anticoagulation therapy, or will refuse blood transfusions
Be a solid organ transplant recipient. This does not include prior cell based therapy (>12 months prior to enrollment), bone, skin, ligament, tendon or corneal grafting.
Have a history of organ or cell transplant rejection
Have a clinical history of malignancy within the past 12 months (i.e., subjects with prior malignancy must be disease free for 12 months), except curatively treated basal cell or squamous cell carcinoma or cervical carcinoma
Drug and/or alcohol abuse or dependence within the past 9 months
Be serum positive for HIV, hepatitis B surface antigen, or viremic hepatitis C
Documented presence of a known Left Ventricular (LV) thrombus, aortic dissection, or aortic aneurysm. (Refer to "Guidance to the PI" section with regards to LV thrombus, below)*
Blood glucose levels (HbA1c) >10%
Severe radiographic contrast allergy
Known history of anaphylactic reaction to penicillin or streptomycin
Hypersensitivity to dimethyl sulfoxide (DMSO)
Non-cardiac condition with life expectancy < 1 year

Where it is running

Stanford University — Stanford, California, United States (enrolling)
University of Miami Miller School of Medicine — Miami, Florida, United States (enrolling)
University of Louisville — Louisville, Kentucky, United States (enrolling)
Texas Heart Institute — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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