September 25, 2017 — BioCardia Inc. announced the trial design for its pivotal Phase III CardiAMP Heart Failure Trial was presented 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, Sept. 15-16 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, M.D., presented 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 clinical 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.
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.
For more information: www.biocardia.com