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CardiAMP Heart Failure II Trial for Patients With Ischemic Heart Failure With Reduced Ejection Fraction
Sponsor: BioCardia, Inc.
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.
Official title: Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy System in Patients With Ischemic Heart Failure II Trial
Key Details
Gender
All
Age Range
21 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2024-08-01
Completion Date
2029-04-01
Last Updated
2026-02-09
Healthy Volunteers
No
Conditions
Interventions
Autologous 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