HOUSTON & SAN CARLOS, Calif.--(BUSINESS WIRE)--BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced that the trial design for its pivotal Phase III CardiAMP Heart Failure Trial will be presented tomorrow during the “Heart Failure: The Big Target for CV Regenerative Therapy State of the Field” session at the Texas Heart Institute International Symposium on Cardiovascular Regenerative Medicine in Houston. As an invited faculty member for the meeting, Professor of Cardiovascular Medicine at the University of Florida and Study Co-National Principal Investigator Carl Pepine, MD is presenting the design.
CardiAMP therapy, an investigational product, takes a personalized and minimally-invasive approach to the use of stem cells for treating heart failure from a heart attack, learning from unsuccessful methods that have come before. By screening for patients with a higher likelihood of benefiting from treatment and delivering a high target dose of 200 million of a patient’s own bone marrow cells directly to injured cardiac tissue using a proprietary delivery system, CardiAMP therapy is designed to stimulate the body’s natural healing response.
The CardiAMP Heart Failure Trial is a Phase III, multi-center, randomized, double-blinded, sham-controlled study at 40 centers nationwide of up to 260 patients, which includes a 10-patient roll-in cohort. The trial’s primary endpoint is an improvement in six-minute walking distance at 12 months’ post-treatment. In addition, the primary endpoint analysis incorporates the impact of major adverse cardiac events and other clinically meaningful events.
“We have designed the CardiAMP therapy and pivotal trial to study a new approach to using bone marrow stem cells to address heart failure. Recognizing that earlier bone marrow cell therapies have been unsuccessful or inconclusive, we have learned from others’ experience,” said BioCardia Chief Medical Officer Eric Duckers, MD. “CardiAMP therapy incorporates a proprietary biomarker screening test to identify patients at a higher likelihood of benefiting from therapy before delivering it, which is designed to optimize outcomes and improve upon earlier results.”
He continued, “We target a high dose of 200 million stem cells, as a high dosage has been associated with improved heart function in previous studies and may improve the opportunity to impact target tissue. Lastly, by using autologous bone marrow cells rather than donor cells, we may improve the body’s acceptance of the therapy and minimize infection risk and complications.”
The company also announced the launch of a new website designed to support patient recruitment for the CardiAMP Heart Failure Trial. On the site, prospective patients can learn more about heart failure and the CardiAMP cell therapy system, and be screened for participation in the trial. The website can be visited at www.cardiamp.com.
Earlier CardiAMP studies – including the Phase II TAC-HFT-BMC trial – have shown an excellent safety profile with statistically significant improvements in patient quality of life and functional capacity. Delivery of stem cell therapy to the heart using the Helix™ transendocardial delivery system incorporated in CardiAMP therapy has been shown to result in superior cell delivery than either percutaneous intra-coronary infusion or direct injection in an open chest procedure.
BioCardia, Inc., headquartered in San Carlos, CA, is developing regenerative biologic therapies to treat cardiovascular disease. CardiAMP® and CardiALLO® cell therapies are the company’s biotherapeutic product candidates in clinical development. For more information, visit www.BioCardia.com.
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