BioCardia, Inc. announced positive interim results from the Phase III randomized controlled trial of its CardiAMP® autologous cell therapy in 110 randomized patients with advanced chronic heart failure at a mean 20-month follow-up, (CardiAMP HF). Results showed reductions in heart death equivalents and MACCE, with a magnified reduction among patients with elevated NTproBNP, a common marker of heart distress. The data was presented by Amish Raval, MD, Director of Clinical Cardiovascular Research and Professor of Medicine at the University of Wisconsin-Madison at the Technology and Heart Failure Therapeutics (THT) 2024 annual meeting.

Over a mean 20 months of follow-up, patients with advanced chronic heart failure who received a single endomyocardial dose of autologous CardiAMP cell therapy while on maximal medical therapy had a 37% relative risk reduction in all-cause heart death equivalents and a 9% relative risk reduction in non-fatal incidence of heart attacks, strokes, and hospitalization due to heart failure (MACCE). Patients treated with CardiAMP cell therapy saw an almost 5% lower rate of heart death equivalents at up to two years compared to control patients treated with heart failure medication alone (8.3% vs. 13.2%, respectively).

CardiAMP cell therapy was also associated with trends toward reduced ventricular tachyarrhythmias, enhanced heart function as measured by left ventricular ejection fraction, and improved NTproBNP. In a subgroup analysis of patients with elevated NTproBNP at baseline ? encompassing 59% of total enrolled randomized patients ?

patients treated with CardiAMP cell therapy experienced an 86.2% relative risk reduction in heart death equivalents and a 23.9% relative risk reduction in MACCE. These patients saw more than a 17% lower rate of heart death equivalents at up to two years compared to control patients treated with heart failure medication alone (2.9% vs. 21.1%, respectively).

Also at the THT scientific meeting, first enrollment for the dose escalation safety phase of BioCardia?s Phase I/II study of the CardiALLO? allogeneic mesenchymal stem cell (MSC) therapy in heart failure patients was reported. The cohort receiving the lowest dose of 20 million cells has been initiated with no treatment-emergent adverse events, arrhythmias, rejection, or allergic response.

The first author of the study is R. David Anderson, MD, Professor of Medicine at the University of Florida at Gainesville. Following completion of the dose escalation safety phase of the study, a Phase II randomized double-blind controlled study is planned to assess efficacy.