CardiAMP Heart Failure II Trial for Patients With Ischemic Heart Failure With Reduced Ejection Fraction

BioCardia

Status: Enrolling

Conditions: Ischemic Heart Failure

Treatments: Device: Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy system

Study type: Interventional

Funder types: Industry

Identifiers

NCT06258447

05804 (CLIN)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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250 participants in 2 patient groups

Study (ABM MNC) Treatment

Experimental group

Description:

Left ventricular catheterization with treatment consisting of autologous bone marrow mononuclear cells (ABM MNC) processed and delivered using the CardiAMP cell therapy system

Treatment:

Device: Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy system

Control Treatment

Sham Comparator group

Description:

Left ventricular (diagnostic) catheterization but no administration of ABM MNC

Treatment:

Device: Autologous bone marrow mononuclear cells processed / delivered using the CardiAMP cell therapy system