MINNEAPOLIS- May 02, 2018- The University of Minnesota is the first institution in the state to participate in the phase III clinical trial for CardiAmp Therapy. Previous clinical studies of this therapy have been promising and have shown improvements in patients' quality of life and heart function.
The CardiAMP investigational therapy is a minimally invasive treatment for ischemic heart failure which occurs after a heart attack. The therapy includes a pre-procedure screening test. A small bone marrow sample is taken and screened to identify patients with a higher likelihood of benefitting from the treatment.
If a patient with University of Minnesota Health qualifies for the therapy, additional bone marrow is collected, which is immediately processed to concentrate the cells into the therapeutic dosage. The dose is then delivered through a catheterization procedure directly into the damaged portions of the heart. Therefore, the patient's own cells are used in a therapy designed to stimulate the body's natural healing response.
"Treatment of heart failure can be very challenging to the patient as well as for the care providers. CardiAMP is an investigational therapy using patients' own cell lines to treat the failing heart muscle," said Ganesh Raveendran, MD, Associate Professor of Medicine, Cardiovascular Division, University of Minnesota Medical School. "This therapy, if proven to be successful, could complement the current treatment modalities available to the patient and eventually reduce the need for LVAD therapy and heart transplantation."
Heart failure is a serious, chronic, and progressive condition in which the heart muscle is unable to pump enough blood to meet the body's needs, and, for which typically there is no cure. However, many people with heart failure lead full, happy lives when the condition is managed properly. In 2015, an estimated 5.7 million Americans over the age of 20 were reported to have heart failure, according to the American Heart Association (AHA). The prevalence of heart failure continues to increase due to the aging population and the increase in major cardiovascular risk factors, including obesity and diabetes.
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About the CardiAMP Heart Failure Trial
The CardiAMP Heart Failure Trial is a phase III, multi-center, randomized, double-blinded, sham-controlled study of up to 260 patients at up to 40 centers nationwide. The primary endpoint for the trial is a significant improvement in Six Minute Walk distance at 12 months' post-treatment. Other endpoints include major adverse cardiac and cerebrovascular events and mortality. Study subjects must be diagnosed with New York Heart Association (NYHA) Class II or III heart failure that has developed after a previous heart attack. The trial is sponsored by BioCardia, Inc., headquartered in San Carlos, Calif., which is developing regenerative biologic therapies to treat cardiovascular disease.