BioCardia has announced that it has resumed cases in the CardiAMP Heart Failure Trial. The first patient procedure completed since elective procedures were paused due to COVID-19 took place at Morton Plant Hospital in Clearwater, Florida, USA, this month. New consents have also taken place at additional centres.
The company statement explains that the CardiAMP Heart Failure Trial is studying CardiAMP cell therapy, an autologous bone marrow-derived mononuclear cell formulation designed to stimulate the body’s natural healing response in treating heart failure which develops after a heart attack. The trial is evaluating the cell therapy’s ability to improve patient survival, exercise capacity, and quality of life, as well as its safety. It says the CardiAMP Heart Failure Trial is the first multicentre clinical trial of an autologous cell therapy to prospectively select patients based on cell potency to maximise the probability of patient benefit.
The ongoing multicentre, double-blinded, randomised (3:2), controlled pivotal CardiAMP Heart Failure Trial is expected to enrol 260 patients at up to 40 centres nationwide. The national coprincipal investigators are Amish Raval, University of Wisconsin, Madison, USA, and Carl Pepine, University of Florida, Gainesville, USA.
In March 2020, the Data Safety Monitoring Board indicated there were no safety concerns with the CardiAMP study results and recommended that the trial continue, as planned. To date, 75 patients have been enrolled at 25 active centers. The trial is sponsored, in part, by the Maryland Stem Cell Research Foundation and has reimbursement from the Centers for Medicare and Medicaid Services (CMS).
BioCardia CEO Peter Altman says: “We are pleased to be able to resume enrollment at several sites for our lead clinical programme and look forward to cases taking place in July and August. As study centres resume elective procedures, we are working closely with our clinical partners to implement new FDA recommendations [Food and Drug Administration] for clinical trials with respect to COVID-19 in order to minimise the impact on our patients, as well as the trial ahead. COVID-19 has been reported to cause heart damage, and some of our clinical investigators are seeing an increased amount of heart damage in patients who have avoided treatment due to fear of COVID-19 exposure. Our cardiac programmes have the potential to help address this growing clinical need, and are even more important in the current clinical landscape.”