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

Recruiting · NCT06258447 · Interventional (participants receive a specific treatment) · Lead sponsor: BioCardia, Inc.

View the official record on ClinicalTrials.gov →

Interventions studied

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

What this trial is 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.

Who can take part

Age range

21 Years to 90 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

5 locations listed across 5 US states.

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

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →