CardiAMP cell therapy for ischemic heart failure
Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy System in Patients With Ischemic Heart Failure II Trial
NA · BioCardia, Inc. · NCT06258447
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 21 Years to 90 Years |
| Sex | All |
| Sponsor | BioCardia, Inc. (industry) |
| Locations | 5 sites (Clearwater, Florida and 4 other locations) |
| Trial ID | NCT06258447 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous studies utilizing similar regenerative approaches with bone marrow-derived cells have shown promising results, indicating potential for success in this trial.
Eligibility criteria
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 this trial is running
Clearwater, Florida and 4 other locations
- Morton Plant Hospital - BayCare — Clearwater, Florida, United States (RECRUITING)
- Emory University — Atlanta, Georgia, United States (RECRUITING)
- Henry Ford Hospital — Detroit, Michigan, United States (RECRUITING)
- Cleveland Clinic — Cleveland, Ohio, United States (WITHDRAWN)
- University of Wisconsin-Division of Cardiovascular Medicine — Madison, Wisconsin, United States (RECRUITING)
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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ischemic Heart Failure