CardiAMP™ Cell Therapy for Heart Failure Trial

Completed · Phase 3 · Has a placebo group

Conditions studied: Heart Failure, Systolic

In brief

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.

Key facts

Study ID

NCT02438306

Run by

BioCardia, Inc.

People needed

125

Starts

2016-12-01

Expected to finish

2025-06-01

Last updated by the study team

2025-09-19

Who can join

Age: 21 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Other cardiac or vascular system or other health-related criteria which may be seen in a patient's history and physical examination.

Where it is running

• Mayo Clinic — Phoenix, Arizona, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Stanford Medical Center, Stanford Health Care — Palo Alto, California, United States
• California Pacific Medical Center — San Francisco, California, United States
• University of Colorado, Denver — Aurora, Colorado, United States
• Morton Plant Mease Health Care — Clearwater, Florida, United States
• University of Florida - College of Medicine/ div of Cardiovascular Medicine — Gainesville, Florida, United States
• Iowa Heart — Des Moines, Iowa, United States
• John Hopkins University School of Medicine - Dept of Cardiology — Baltimore, Maryland, United States
• Suburban Hospital — Bethesda, Maryland, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Michigan Cardiovascular Institute — Saginaw, Michigan, United States
• Michigan Heart - St.Joseph Mercy Health System (Trinity Health) — Ypsilanti, Michigan, United States
• Atlantic Health System — Morristown, New Jersey, United States
• New York University School of Medicine — New York, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Oklahoma Heart — Tulsa, Oklahoma, United States
• Stern Cardiovascular Foundation — Memphis, Tennessee, United States
• Virginia Commonwealth University (VCU) Medical Center — Richmond, Virginia, United States
• Division of Cardiovascular Medicine, University of Wisconsin Hospital and Clinics — Madison, Wisconsin, United States
• St. Paul's Hospital — Vancouver, British Columbia, Canada
• London Health Sciences Center — London, Ontario, Canada
• Ottawa Heart Institute — Ottawa, Ontario, Canada
• Unity Health Toronto — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.