CardiAMP cell therapy for ischemic heart failure
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
Run by BioCardia, Inc. · NCT06258447 · Data updated 2026-11-12
This study is testing a new cell therapy for people with ischemic heart failure to see if it can help improve their heart function compared to a standard procedure.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 21 Years to 90 Years |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | BioCardia, Inc. Industry-sponsored |
| Locations | 5 sites (Clearwater, Florida and 4 other locations) |
| Status | Recruiting |
| Started | August 1, 2024 |
| Main results expected | April 1, 2027 |
| Study ends | April 1, 2029 |
| Registry record updated | February 9, 2026 |
| Trial ID | NCT06258447 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals with chronic ischemic left ventricular dysfunction, classified as NYHA Class II or III, and with specific ejection fraction and NTproBNP levels.
✕Probably not a fit
Patients who are not optimal candidates for cardiac catheterization or intramyocardial delivery of cells, as defined by the study protocol, may not benefit from this therapy.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the safety and efficacy of the CardiAMP cell therapy system, which utilizes concentrated autologous bone marrow mononuclear cells (ABM MNC), in patients suffering from ischemic heart failure with reduced ejection fraction. It is a prospective, multi-center, randomized, controlled trial that compares the treatment group receiving ABM MNC via intramyocardial delivery to a control group undergoing diagnostic catheterization without cell therapy. The study aims to provide new therapeutic options for chronic heart failure, leveraging regenerative medicine approaches supported by previous clinical data.
Why it matters
Potential benefit: If successful, this therapy could significantly improve heart function and quality of life for patients with ischemic heart failure.
How similar studies have gone: Previous studies utilizing similar regenerative approaches with bone marrow-derived cells have shown promising results, indicating potential for success in this trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
-
Morton Plant Hospital - BayCare
Clearwater, Florida, United States Recruiting -
Emory University
Atlanta, Georgia, United States Recruiting -
Henry Ford Hospital
Detroit, Michigan, United States Recruiting -
University of Wisconsin-Division of Cardiovascular Medicine
Madison, Wisconsin, United States Recruiting -
Cleveland Clinic
Cleveland, Ohio, United States Withdrawn
Study contacts
- Principal investigator: Amish Raval, MD — University of Wisconsin, Madison
- Study coordinator: Debby Holmes-Higgin, MS, MPH
- Email: debbyhh@biocardia.com
- Phone: 650-226-0120
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
FAPI Imaging to gauge revascularization outcomes in ischemic heart failure
This study tests whether a special imaging test (FAPI) can help predict how well people with ischemic heart failure will respond after revascularization.
-
Endocardial delivery of stem-cell derived heart cells to help severe heart failure
This study tests endocardial delivery of HS-001 cell sheets made from iPSC-derived cardiomyocytes in adults with severe heart failure and reduced ejection fraction to see if it is safe and may improve heart function over 26 weeks.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.