Administration of Allogeneic-MSC in Patients With Non-Ischemic Dilated Cardiomyopathy
ConditionNon-ischemic Dilated Cardiomyopathy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorJoshua M Hare
About this trial
The purpose of this study is to evaluate the safety and effectiveness of an experimental drug called human allogeneic mesenchymal stem cell therapy.
Eligibility criteria
Qualifiers
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*
Disqualifiers
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*
Trial design
Treatments tested in this trial
- allogeneic human mesenchymal stem cells (hMSCs)
- Placebo
Treatment groups
136 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Joshua M Hare
Lead sponsor
University of Miami
Sponsor institution
United States Department of Defense
Collaborator
The University of Texas Health Science Center, Houston
Collaborator
Source ClinicalTrials.gov