CardiAMP™ Cell Therapy for Heart Failure Trial
- Conditions
- Heart Failure, Systolic
- Interventions
- Biological: Autologous cell therapyOther: Sham
- Registration Number
- NCT02438306
- Lead Sponsor
- BioCardia, Inc.
- Brief Summary
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.
- Detailed Description
Heart failure is a clinical condition in which the output of blood from the heart is insufficient to meet the metabolic demands of the body. In 2015, the American Heart Association, or AHA, report on heart disease statistics estimated that there are 5.7 million Americans over the age of 20 that have heart failure. Heart failure is increasingly prevalent due to the aging population and the increase in major cardiovascular risk factors, including obesity and diabetes.
The AHA also estimates that one in five adults will develop heart failure after the age of 40. During heart failure progression, the heart steadily loses its ability to respond to increased metabolic demand, and mild exercise soon exceeds the heart's ability to maintain adequate output. Towards the end stage of the disease, the heart cannot pump enough blood to meet the body's needs at rest. At this stage, fluids accumulate in the extremities or in the lungs making the patient bedridden and unable to perform the activities of daily living. The long-term prognosis associated with heart failure is approximately 50% mortality at five years following the initial diagnosis.
CardiAMP cell therapy is a comprehensive therapeutic treatment that comprises (i) a point of care cell processing platform and (ii) a biotherapeutic delivery system. CardiAMP cell therapy is the first comprehensive therapeutic treatment utilizing a patient's own cells for the treatment of ischemic heart failure with reduced ejection fraction. In the screening process, the physician extracts a small sample of the patient's bone marrow in an outpatient procedure performed under local anesthesia. The clinic sends the sample to a central diagnostic lab, which tests the sample. For the study treatment, a clinician collects and then prepares the patient's own bone marrow mononuclear cells, or autologous cells, using the CardiAMP point of care cell processing platform, which a cardiologist then delivers into the heart using the Helix biotherapeutic delivery system.
BioCardia intends to submit data obtained from this clinical trial in a Pre-Market Approval Application to the United States Food and Drug Administration
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 125
- 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
• Other cardiac or vascular system or other health-related criteria which may be seen in a patient's history and physical examination.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CardiAMP cell therapy Autologous cell therapy Placement of an introducer guidewire, performance of a left ventriculogram, and treatment with autologous cell therapy. Sham Comparator Sham Placement of an introducer guidewire and performance of a left ventriculogram with no autologous cell therapy treatment.
- Primary Outcome Measures
Name Time Method A composite endpoint based on a 3-tiered Finkelstein-Schoenfeld (FS) hierarchical analysis. 12 Months The tiers include (1) all-cause death, (2) non-fatal MACCE events, and (3) change for 6MWD from baseline to month 12.
- Secondary Outcome Measures
Name Time Method Minnesota Living with Heart Failure Questionnaire (MLHFQ) 12 months Mean change in quality of life score as measured by the MLHFQ at 12 months compared to baseline (superiority, treatment vs sham)
Time to first Major Adverse Cardiac Events (MACE) 12 months Time to first MACE, defined as the composite of all-cause death, hospitalization for worsening heart failure, nonfatal recurrent myocardial infarction, placement of a left ventricular assist device (LVAD), or heart transplantation (non-inferiority, treatment vs sham)
Survival 12 Months Overall survival compared between both study arms (non-inferiority, treatment vs sham)
Trial Locations
- Locations (25)
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States
John Hopkins University School of Medicine - Dept of Cardiology
🇺🇸Baltimore, Maryland, United States
Atlantic Health System
🇺🇸Morristown, New Jersey, United States
University of Florida - College of Medicine/ div of Cardiovascular Medicine
🇺🇸Gainesville, Florida, United States
Iowa Heart
🇺🇸Des Moines, Iowa, United States
Division of Cardiovascular Medicine, University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States
St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
Virginia Commonwealth University (VCU) Medical Center
🇺🇸Richmond, Virginia, United States
Unity Health Toronto
🇨🇦Toronto, Ontario, Canada
London Health Sciences Center
🇨🇦London, Ontario, Canada
Ottawa Heart Institute
🇨🇦Ottawa, Ontario, Canada
Michigan Cardiovascular Institute
🇺🇸Saginaw, Michigan, United States
Mayo Clinic
🇺🇸Phoenix, Arizona, United States
University of Colorado, Denver
🇺🇸Aurora, Colorado, United States
Suburban Hospital
🇺🇸Bethesda, Maryland, United States
Stanford Medical Center, Stanford Health Care
🇺🇸Palo Alto, California, United States
MedStar Health Research Institute
🇺🇸Washington, District of Columbia, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Michigan Heart - St.Joseph Mercy Health System (Trinity Health)
🇺🇸Ypsilanti, Michigan, United States
Morton Plant Mease Health Care
🇺🇸Clearwater, Florida, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
New York University School of Medicine
🇺🇸New York, New York, United States
Oklahoma Heart
🇺🇸Tulsa, Oklahoma, United States
Stern Cardiovascular Foundation
🇺🇸Memphis, Tennessee, United States