BioCardia reports interim results from Phase III CardiAMP cell therapy trial

BioCardia 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. Results showed reductions in heart death equivalents and MACCE, with a magnified reduction among patients with elevated NTproBNP, a common marker of heart distress. 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. 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. 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.