Concentrated autologous bone marrow mononuclear cells (ABM MNC) contain potentially therapeutic cell factors and past studies support therapeutic benefit to patients with cardiac diseases of acute myocardial infarction, ischemia, and heart failure when utilized as this study is designed. The purpose of the study is to determine the safety and efficacy of CardiAMP cell therapy system in patients with ischemic heart failure. It is a prospective, multi-center, randomized, controlled, patient and evaluator-blinded study comparing treatment with the CardiAMP cell therapy system to a control procedure with diagnostic catheterization.
Chronic heart failure is in need of new therapies. Over the past few years, cardiovascular regenerative medicine using bone marrow derived cells has emerged as a new treatment strategy that could have tremendous benefit in treating heart failure and are well supported by recent meta analyses of early clinical data sets. Concentrated autologous bone marrow mononuclear cells (ABM MNC) are the subject of the current study as they are supported by more clinical data than any other cell type described, and contain all of the potentially therapeutic cell factors from studies of selected cells. Study results demonstrate ABM MNC to be safe, and, when delivered intramyocardially as intended in the current study, results consistently support therapeutic benefit to patients with cardiac diseases of acute myocardial infarction, ischemia, and heart failure. The purpose of the study is to determine the safety and efficacy of CardiAMP cell therapy system in patients with ischemic heart failure. It is a prospective, multi-center, randomized, controlled, patient and evaluator-blinded study comparing treatment with the CardiAMP cell therapy system to a control procedure with diagnostic catheterization. The Treatment Group undergoes left ventricular catheterization and is treated with ABM MNC using the CardiAMP cell therapy system. The Control Group has a Control procedure consisting of left ventricular diagnostic catheterization but no introduction of the Helix transendocardial delivery catheter and no administration of ABM MNC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
250
the ABM MNC is obtained from the study patient via bone marrow aspiration in the hip and processed and delivered using the CardiAMP cell therapy system during the cardiac catheterization.
Morton Plant Hospital - BayCare
Clearwater, Florida, United States
RECRUITINGEmory University
Atlanta, Georgia, United States
RECRUITINGHenry Ford Hospital
Detroit, Michigan, United States
RECRUITINGCleveland Clinic
Cleveland, Ohio, United States
WITHDRAWNUniversity of Wisconsin-Division of Cardiovascular Medicine
Madison, Wisconsin, United States
RECRUITINGPrimary Efficacy Endpoint
The primary efficacy endpoint is the comparison of a composite score based on a 3-tiered Finkelstein-Schoenfeld (FS) hierarchical analysis. The tiers, starting with the most serious events, would be (1) all cause death, including cardiac death equivalents such as heart transplant or left ventricular assist device placement, ordered by time to event; (2) non-fatal MACCE events (heart failure hospitalization or a worsening heart failure, stroke or MI) ordered by time to event, excluding those deemed procedure related occurring within the first 7 days, and (3) change for quality of life as measured using the Minnesota Living with Heart Failure Questionnaire (MLwHFQ)
Time frame: Follow-up duration at endpoint analysis ranges from a minimum of 12 to a maximum of 24 months
First Secondary Endpoint
Time to all-cause death, LVAD/heart transplant, or heart failure hospitalization
Time frame: Baseline through study completion, maximum of two years
Second Secondary Endpoint
Cumulative heart failure hospitalizations
Time frame: Baseline through study completion, maximum of two years
Third Secondary Endpoint
Time to first heart failure hospitalization
Time frame: Baseline through study completion, maximum of two years
Fourth Secondary Endpoint
Change in quality of life as measured using the MLwHF questionnaire based on a scale of 0-105, with 0 being best.
Time frame: Baseline to 12 months, 24 months
Fifth Secondary Endpoint
Change in quality of life as measured using the Kansas City Cardiomyopathy questionnaire (KCCQ), based on a scale of 0-100, with 100 being best
Time frame: Baseline to 12 months, 24 months
Sixth Secondary Endpoint
Change in functional capacity as measured using the 6-minute walk test (6MWT)
Time frame: Baseline to 12 months, 24 months
Seventh Secondary Endpoint
Modified Primary Efficacy Endpoint consisting of all-cause death, LVAD/heart transplant, heart failure hospitalizations and worsening heart failure events treated as an outpatient but without a quality-of-life measure
Time frame: Baseline through study completion, maximum of two years
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