Tests a patient's own bone marrow cells for ischemic heart failure
Tests the CardiAMP system, using a patient's own bone marrow cells, in ischemic heart failure.
Plain-language title generated from the registry record
Registry title: CardiAMP Heart Failure II Trial for Patients With Ischemic Heart Failure With Reduced Ejection Fraction
Key facts
- Where
- Atlanta, Clearwater, Cleveland, Detroit, and Madison, United StatesSee the 5 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 21 and 90 years old?
Source: NCT06258447, who can take part
Where in United States
- Emory UniversityAtlanta, United StatesTaking people
- Morton Plant Hospital - BayCareClearwater, United StatesTaking people
- Cleveland ClinicCleveland, United StatesNo longer taking part
- Henry Ford HospitalDetroit, United StatesTaking people
- University of Wisconsin-Division of Cardiovascular MedicineMadison, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- BioCardia, Inc.
- Trial code
- NCT06258447
- Record updated
- 9 February 2026
- Original description
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.Read full original descriptionShow less
Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy System in Patients With Ischemic Heart Failure II Trial
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.
Inclusion: 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: 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.