Heart Failure Clinical Trial
CardiAMP™ Cell Therapy for 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.
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
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.
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There are 22 Locations for this study
Phoenix Arizona, 85054, United States
Los Angeles California, 90048, United States
Palo Alto California, 94305, United States
San Francisco California, 94115, United States
Aurora Colorado, 80045, United States
Washington District of Columbia, 20010, United States
Clearwater Florida, 33756, United States
Gainesville Florida, 32606, United States
Des Moines Iowa, 50266, United States
Baltimore Maryland, 21287, United States
Bethesda Maryland, 20814, United States
Detroit Michigan, 48202, United States
Saginaw Michigan, 48601, United States
Ypsilanti Michigan, 48197, United States
Morristown New Jersey, 07960, United States
New York New York, 10010, United States
Cleveland Ohio, 44195, United States
Tulsa Oklahoma, 74104, United States
Memphis Tennessee, 38103, United States
Richmond Virginia, 23298, United States
Madison Wisconsin, 53792, United States
Vancouver British Columbia, , Canada
London Ontario, , Canada
Ottawa Ontario, KIY 4, Canada
Toronto Ontario, , Canada
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