CardiAMP™ Cell Therapy Heart Failure Trial
This is a prospective, multi-center, randomized (3 Treatment : 2 Sham Control), sham-controlled, patient- and evaluator-blinded study comparing treatment with the CardiAMP cell therapy to a sham treatment. A roll-in phase with a maximum of 10 subjects may occur.
|Condition or Disease||Intervention/Treatment||Phase|
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 is a comprehensive therapeutic treatment that comprises (i) a point of care cell processing platform, and (ii) a biotherapeutic delivery system. CardiAMP is the first comprehensive therapeutic treatment utilizing a patient's own cells for the treatment of ischemic systolic heart failure, which is heart failure that develops after a heart attack. 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 centralized diagnostic lab, which tests the sample. During the treatment, a clinician harvests 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
Arms and Interventions
|Experimental: CardiAMP cell therapy|
Placement of an introducer guidewire, performance of a left ventriculogram, and treatment with autologous cell therapy.
Biological: Autologous cell therapy
Autologous cell therapy delivered into the heart muscle using the CardiAMP Cell Therapy System. The CardiAMP Cell Therapy System consists of the CardiAMP Cell Separator, a cardiac delivery catheter, and flexible tip guide catheter.
|Sham Comparator: Sham Comparator|
Placement of an introducer guidewire and performance of a left ventriculogram with no autologous cell therapy treatment.
An introducer guidewire is placed into the heart and left ventriculography is performed just like it is in the Experimental Arm but no autologous cell therapy is delivered.
Primary Outcome Measures
- 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
- Survival Rate [12 Months]
Survival rate compared between both study arms (non-inferiority, treatment vs sham)
- Major Adverse Cardiac Events (MACE) [12 months]
Freedom from 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)
- 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 MACE [12 months]
Time (in days) to first MACE during the 12 months after the baseline measurements (superiority, treatment vs sham)
- Survival rate [12 months]
Survival rate compared between both study arms (superiority, treatment vs sham)
New York Heart Association (NYHA) Class II or III
A diagnosis of chronic ischemic left ventricular dysfunction secondary to myocardial infarction (MI).
On stable evidence-based medical and device therapy for heart failure or post-infarction left ventricular dysfunction, per the 2013 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 bone-marrow aspiration
• Other cardiac or vascular system or other health-related criteria which may be seen in a patient's history and physical examination.
Contacts and Locations
|1||Cardiology PC||Birmingham||Alabama||United States||35211|
|2||Mayo Clinic||Phoenix||Arizona||United States||85054|
|3||USC||Los Angeles||California||United States||90033|
|4||Cedars Sinai Medical Center||Los Angeles||California||United States||90048|
|5||Stanford Medical Center, Stanford Health Care||Palo Alto||California||United States||94305|
|6||California Pacific Medical Center||San Francisco||California||United States||94115|
|7||University of Colorado, Denver||Aurora||Colorado||United States||80045|
|8||MedStar Health Research Institute||Washington||District of Columbia||United States||20010|
|9||Morton Plant Mease Health Care||Clearwater||Florida||United States||33756|
|10||University of Florida - College of Medicine/ div of Cardiovascular Medicine||Gainesville||Florida||United States||32606|
|11||Northwestern University||Chicago||Illinois||United States||60611|
|12||Iowa Heart||Des Moines||Iowa||United States||50266|
|13||John Hopkins University School of Medicine - Dept of Cardiology||Baltimore||Maryland||United States||21287|
|14||Suburban Hospital||Bethesda||Maryland||United States||20814|
|15||Henry Ford Hospital||Detroit||Michigan||United States||48202|
|16||Michigan Cardiovascular Institute||Saginaw||Michigan||United States||48601|
|17||Michigan Heart - St.Joseph Mercy Health System (Trinity Health)||Ypsilanti||Michigan||United States||48197|
|18||University of Minnesota||Minneapolis||Minnesota||United States||55455|
|19||Atlantic Health System||Morristown||New Jersey||United States||07960|
|20||New York University School of Medicine||New York||New York||United States||10010|
|21||Cornell University||New York||New York||United States||10065|
|22||Oklahoma Heart||Tulsa||Oklahoma||United States||74104|
|23||Texas Heart Institute||Houston||Texas||United States||77030|
|24||Virginia Commonwealth University (VCU) Medical Center||Richmond||Virginia||United States||23298|
|25||Swedish Health Services||Seattle||Washington||United States||98122|
|26||Division of Cardiovascular Medicine, University of Wisconsin Hospital and Clinics||Madison||Wisconsin||United States||53792-0001|
Sponsors and Collaborators
- BioCardia, Inc.
- Principal Investigator: Carl Pepine, MD, University of Florida
- Principal Investigator: Amish Raval, MD, University of Wisconsin, Madison
Study Documents (Full-Text)None provided.
- Website for the study sponsor
- Website with additional information for patients, family members or friends