RecruitingNot ApplicableNCT06258447

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

Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy System in Patients With Ischemic Heart Failure II Trial

Sponsor

BioCardia, Inc.

Enrollment

250 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Ischemic Heart Failure

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.

Eligibility

Min Age: 21 YearsMax Age: 90 Years

Inclusion Criteria6

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 Criteria1

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.

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.

Locations(5)

Morton Plant Hospital - BayCare

Clearwater, Florida, United States

Emory University

Atlanta, Georgia, United States

Henry Ford Hospital

Detroit, Michigan, United States

Cleveland Clinic

Cleveland, Ohio, United States

University of Wisconsin-Division of Cardiovascular Medicine

Madison, Wisconsin, United States

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NCT06258447