Ischemic Heart Failure
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAutologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy system
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.
Sponsors
BioCardia, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind including study participants and care provider (investigator) conducting outcomes assessments
Intervention model description
Controlled study of study treatment consisting of intramyocardial autologous cell injections compared to sham control, both performed in cardiac catheterization
Eligibility
Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* New York Heart Association (NYHA) Class II or III * Diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI) as described in the study protocol. * Left ventricular ejection fraction \>20% and \<40% * On stable evidence-based medical and device therapy for ischemic etiology heart failure per the ACC/AHA Heart Failure guidelines, for at least three (3) months prior to randomization. * NTproBNP level of \>500 pg/ml * Autologous cell analysis score consistent with study selection assessment
Exclusion criteria
* Selected study criteria as defined in the study protocol indicating that patient is not an optimal candidate for cardiac catheterization or intramyocardial delivery of autologous bone marrow mononuclear cells.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy Endpoint | Follow-up duration at endpoint analysis ranges from a minimum of 12 to a maximum of 24 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| First Secondary Endpoint | Baseline through study completion, maximum of two years | Time to all-cause death, LVAD/heart transplant, or heart failure hospitalization |
| Second Secondary Endpoint | Baseline through study completion, maximum of two years | Cumulative heart failure hospitalizations |
| Third Secondary Endpoint | Baseline through study completion, maximum of two years | Time to first heart failure hospitalization |
| Fourth Secondary Endpoint | Baseline to 12 months, 24 months | Change in quality of life as measured using the MLwHF questionnaire based on a scale of 0-105, with 0 being best. |
| Fifth Secondary Endpoint | Baseline to 12 months, 24 months | 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 |
| Sixth Secondary Endpoint | Baseline to 12 months, 24 months | Change in functional capacity as measured using the 6-minute walk test (6MWT) |
| Seventh Secondary Endpoint | Baseline through study completion, maximum of two years | 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 |
Countries
United States
Contacts
CONTACTDebby Holmes-Higgin, MS, MPH
PRINCIPAL_INVESTIGATORAmish Raval, MD
University of Wisconsin, Madison
Outcome results
None listed