A Phase IIB Randomized, Placebo-Controlled, Multicenter Study of the Comparative Efficacy and Safety of Administration of Allogeneic-MSC Versus Placebo in Patients With Non- Ischemic Dilated Cardiomyopathy
Joshua M Hare
Summary
The purpose of this study is to evaluate the safety and effectiveness of an experimental drug called human allogeneic mesenchymal stem cell therapy.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Men and women aged 18 to 80 years (inclusive) at the time of signing the informed consent form. 2. Diagnosis of NIDCM with left ventricular ejection fraction ≤45%. 3. 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…
Interventions
- Biologicalallogeneic human mesenchymal stem cells (hMSCs)
allo-hMSCs, 16-20 million cells/ml delivered at a dose of 0.5 ml/ injection x 10 injections for a total of 80-100 million allo-hMSCs or a single administration of intravenous allogeneic hMSCs (100 million).
- OtherPlacebo
Placebo will be administered as injections of plasmalyte A supplemented with 1% of 25% human serum albumin (HSA). 0.5 ml/ injection x 10 injections or an intravenous placebo infusion of Cell-free PlasmaLyte-A medium supplemented with 1% of 25% human serum albumin (HSA)
Locations (4)
- Stanford UniversityStanford, California
- University of Miami Miller School of MedicineMiami, Florida
- University of LouisvilleLouisville, Kentucky
- Texas Heart InstituteHouston, Texas