Recruiting

CardiAMP

Sponsor:

BioCardia, Inc.

Code:

NCT06258447

Conditions

Ischemic Heart Failure

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief 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.

Conditions

Ischemic Heart Failure

Study ID

NCT06258447

Start date

Aug 1, 2024

Status verified date

Feb, 2026

Completion date

Apr 1, 2029

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Study (ABM MNC) Treatment

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

sham comparator: Control Treatment

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

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.

Primary outcome measure

  • Primary Efficacy Endpoint [ Time Frame: Follow-up duration at endpoint analysis ranges from a minimum of 12 to a maximum of 24 months ]

Central Contacts and Locations

Central contacts

Debby Holmes-Higgin, MS, MPH

650-226-0120debbyhh@biocardia.com

Locations

Morton Plant Hospital - BayCare

Recruiting

Clearwater, Florida, United States, 33756

Contacts

Delia Johnson, RN

Delia.Johnson@baycare.org

Principal Investigator:

Leslie Miller, MD

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Tanveer Kauser Clinical Coordinator

tanveer.kauser@emory.edu

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Melanee Schimmel Clinical Coordinator

MSchimm2@hfhs.org

University of Wisconsin-Division of Cardiovascular Medicine

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Besa Jonuzi

bjonuzi@wisc.edu

More Information

Sponsor

BioCardia, Inc.

Last update posted

Feb 9, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by BioCardia, Inc. on 2026-02-09.