Henry Ford Health Initiates Patient Enrollment for BioCardia’s CardiAMP HF II Pivotal Study for Ischemic Heart Failure of Reduced Ejection Fraction

Core Viewpoint - BioCardia, Inc. is advancing its CardiAMP HF II trial for ischemic heart failure, enrolling patients at Henry Ford Health, aiming to confirm the efficacy of its autologous cell therapy [1][2][4] Company Overview - BioCardia, Inc. is a leader in cellular and cell-derived therapeutics focused on cardiovascular and pulmonary diseases, with its headquarters in Sunnyvale, California [9] - The company is developing two biotherapeutic platforms: CardiAMP autologous and CardiALLO™ allogeneic cell therapies, with three clinical stage product candidates [9] Clinical Trial Details - The CardiAMP HF II trial is a 250-patient randomized multicenter placebo-controlled study targeting patients with ischemic HFrEF on guideline-directed medical therapy [4] - The trial aims to confirm safety and efficacy results observed in the previous CardiAMP HF study, utilizing a three-tier composite primary outcome measure [4] - The investigational therapy involves harvesting patients' own bone marrow cells, which are processed and delivered during a minimally invasive procedure [2][4][6] Importance of the Trial - The CardiAMP HF cell therapy trials are crucial for patients with ischemic heart failure, providing potential new treatment options [2] - The therapy is designed to promote microvascular repair, reduce fibrosis, and increase capillary density, addressing mechanisms of microvascular dysfunction [6] Industry Context - Heart failure affects approximately 6.2 million adults in the U.S., with about 960,000 new cases diagnosed each year [5] - Current treatments for heart failure include lifestyle changes, medications, and surgical procedures, but many patients do not respond well or experience adverse effects [5]