NCT02438306CompletedPhase 3
CardiAMP™ Cell Therapy for Heart Failure Trial
Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy System in Patients With Ischemic Heart Failure (CardiAMP Heart Failure Trial)
Source: ClinicalTrials.gov · Last updated 19 Sept 2025
Brief summary (registry, in English)
This is a prospective, multi-center, randomized, controlled, patient- and evaluator-blinded study comparing treatment with the CardiAMP cell therapy to a sham control treatment. A roll-in phase with a maximum of 10 subjects may occur.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 125 (actual)
- First submitted
- 5 May 2015
- Start date
- 1 Dec 2016
- Primary completion date
- 28 Feb 2025
- Lead sponsor
- BioCardia, Inc.
- Diseases
- Heart failure
- NCT number
- NCT02438306
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 125
- From 1 Dec 2016 to the primary completion date, 28 Feb 2025
- 24 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Other cardiac or vascular system or other health-related criteria which may be seen in a patient's history and physical examination.
Who the study is looking for
- New York Heart Association (NYHA) Class II or III
- A diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI) as defined by selected criteria.
- 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.
- Left ventricular ejection fraction between 20% and 40%.
- Qualification of a pre-procedure screening of the patient's bone-marrow characteristics
Age in the registry: 21 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (24)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| London Health Sciences Center Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| Ottawa Heart Institute Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Unity Health Toronto Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| St. Paul's Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| University of Colorado Denver Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| John Hopkins University School of Medicine - Dept of Cardiology Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Suburban Hospital Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
| Morton Plant Mease Health Care Coordinator of this site? Confirm its status | Clearwater | United States | Unknown status |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Iowa Heart Coordinator of this site? Confirm its status | Des Moines | United States | Unknown status |
| Henry Ford Hospital Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| University of Florida - College of Medicine/ div of Cardiovascular Medicine Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Division of Cardiovascular Medicine, University of Wisconsin Hospital and Clinics Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Stern Cardiovascular Foundation Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| Atlantic Health System Coordinator of this site? Confirm its status | Morristown | United States | Unknown status |
| New York University School of Medicine Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Stanford Medical Center (Stanford Health Care) Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Virginia Commonwealth University (VCU) Medical Center Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| Michigan Cardiovascular Institute Coordinator of this site? Confirm its status | Saginaw | United States | Unknown status |
| California Pacific Medical Center Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Oklahoma Heart Coordinator of this site? Confirm its status | Tulsa | United States | Unknown status |
| Michigan Heart - St.Joseph Mercy Health System (Trinity Health) Coordinator of this site? Confirm its status | Ypsilanti | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.