This is a Phase IIA, randomized, double blind, placebo controlled, multicenter study designed to assess the safety, feasibility, and efficacy of umbilical cord derived mesenchymal stromal cells (UC MSCs, stem cells), administered intravenously (IV) as a single dose or repeated doses, in patients with ischemic cardiomyopathy (ICM).
Be ≥ 21 and ≤ 85 years of age.
Have documented CAD (> 70% lesion in at least 1 epicardial vessel) with evidence of myocardial injury, LV dysfunction, and clinical evidence of HF.
Have a "detectable" area of myocardial injury defined as ≥ 5% LV involvement (infarct volume) and any subendocardial involvement by MRI.
Have an EF ≤ 40% by MRI.
Indication for standard of care surgery (including valve surgery, placement of left ventricular assist device, or imminent heart transplantation), coronary artery bypass grafting (CABG) procedure, and/or percutaneous coronary intervention (PCI) for the treatment of ischemic and/or valvular heart disease. Subjects who require or undergo PCI should undergo these procedures a minimum of 3 months in advance of randomization. Subjects who require or undergo CABG should undergo these procedures a minimum of 3 months in advance of randomization. In addition, subjects who develop a need for revascularization following enrollment should undergo revascularization without delay. Indication for imminent heart transplantation is defined as a high likelihood of transplant prior to collection of the 12 month study endpoint. Candidates cannot be UNOS 1A or 1B, and they must have documented a low probability of being transplanted.
Severe valvular (any valve) insufficiency and/or regurgitation within 12 months of consent
History of ischemic or hemorrhagic stroke within 90 days of consent
manufactured before the year 2000
Parallel
umbilical cord-derived mesenchymal stromal cells (UC-MSCs)
Biological/VaccineThe study product will consist of 100 million UC-MSCs suspended in a final volume of 60 ml given at a rate of 3.3 million cells/min. The product will be infused into vein via intravenous line placed in the arm.
change in LVEF (D LVEF) between baseline (M0) and 12 months after the first study product infusion (SPI) (M12)
Change in left ventricular ejection fraction as assessed via cardiac MRI. Units: %
Change in LV end-systolic volume index (ESVI)
Change in left ventricular end systolic index (LVESVI) as assessed via cardiac MRI. Units: ml/m2
Change in LV end-diastolic volume index (EDVI)
Change in left ventricular end diastolic index (LVEDVI) as assessed via cardiac MRI. Units: ml/m2
Change in LV end-diastolic wall thickness
Change in LV end-diastolic wall thickness as assessed via cardiac MRI. Units: mm
Change in LV wall thickening
Change in LV wall thickening as assessed via cardiac MRI. Units: mm
Serious adverse events
Number of patients experiencing significant adjudicated clinical events including myocardial infarction (MI), stroke, pulmonary embolism, implantable cardioverter-defibrillator (ICD) firing for ventricular fibrillation/tachycardia, ventricular tachycardia (sustained and non-sustained), or hospitalization related to intravenous infusion of UC-MSCs. Units: number of participants who have an incidence of SAE in each group
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Roberto Bolli
Lead sponsor
University of Louisville
Sponsor institution
University of Miami
Collaborator
University of Texas
Collaborator
United States Department of Defense
Collaborator
