The purpose of this study is to evaluate the safety and effectiveness of an experimental drug called human allogeneic mesenchymal stem cell therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
136
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).
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)
Stanford University
Stanford, California, United States
RECRUITINGUniversity of Miami Miller School of Medicine
Miami, Florida, United States
RECRUITINGUniversity of Louisville
Louisville, Kentucky, United States
RECRUITINGChange in LVEF
Change in Left Ventricular Ejection Fraction (LVEF) as assessed via cardiac Magnetic Resonance Imaging (MRI)
Time frame: Baseline, 12 months
Change in global ventricular strain
Change in global ventricular strain as assessed via cardiac Harmonic Phase (HARP) MRI
Time frame: Baseline, 12 months
Change in left regional strain
Change in regional ventricular strain as assessed via cardiac HARP MRI
Time frame: Baseline, 12 months
Left ventricular function concordance
The left ventricular function concordance will be measured as the Number of individuals who experienced an increase in left ventricular ejection fraction (LVEF) and a simultaneous decrease in both left ventricular end systolic volume index (LVESVI) and left ventricular end diastolic volume index (LVEDVI)
Time frame: 12 months
Change in LVEDVI
Change in left ventricular end diastolic index (LVEDVI) as assessed via cardiac MRI
Time frame: Baseline, 12 months
Change in LVESVI
Change in left ventricular end systolic index (LVESVI) as assessed via cardiac MRI
Time frame: Baseline, 12 months
Change in Maximal oxygen consumption (peak VO2)
Change in maximal oxygen consumption (peak VO2) as assessed via treadmill
Time frame: Baseline, 12 months
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Texas Heart Institute
Houston, Texas, United States
RECRUITINGChange in Exercise tolerance
Change in exercise tolerance as assessed as the distance covered via the six-minute walk test
Time frame: Baseline, 12 months
Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) Score
Minnesota Living with Heart Failure Questionnaire (MLHFQ) is a 21-item questionnaire with a total score ranging from 0 to 105 with lower scores indicative of better outcome.
Time frame: Baseline, 12 months
Change in New York Heart Association (NYHA) Class
NYHA Classifications of heart failure are as follows: Class I (no limitations); Class II (mild symptoms); Class III (marked limitations); Class IV (Severe limitations)
Time frame: Baseline, 12 months
Percent change in flow mediated diameter
Change in endothelial function will be reported as the percent change in flow mediated diameter assessed via flow mediated dilation (FMD).
Time frame: Baseline, 12 months
Change in EPC-CFU
Change in endothelial function will be reported as the change in Endothelial Progenitor Cell Colony Forming Unit (EPC-CFU) assessed via blood sample assay
Time frame: Baseline, 12 months
Change in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP)
Change in NT-proBNP as assessed via blooddraw
Time frame: Baseline, 12 months
Change in cytokines
Change in NT-proBNP as assessed via blooddraw
Time frame: Baseline, 12 months
Incidence of MACE
Safety will be reported as the incidence of Major Adverse Cardiac Events (MACE) assessed by treating physician
Time frame: 12 months
Incidence of TE-SAEs
Safety will be reported as the incidence of Treatment Emergent Serious Adverse Events (TE-SAEs) assessed by treating physician
Time frame: Day 30