Core Insights - BioCardia, Inc. has completed enrollment and dosing in the low dose cohort of its CardiALLO™ Allogeneic Mesenchymal Cell Therapy Phase I/II trial aimed at treating patients with ischemic heart failure of reduced ejection fraction (HFrEF) [1][2] - The trial is notable for being the world's first prospective study of allogeneic mesenchymal stem cells (MSC) for HFrEF patients with elevated markers of heart stress and systemic inflammation [1][3] Company Overview - BioCardia, Inc. is a leader in cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, with a focus on developing therapies like CardiAMP™ and CardiALLO for heart disease [5][6] - The company is headquartered in Sunnyvale, California, and is also involved in biotherapeutic delivery partnerships for various heart-related conditions [6] Clinical Trial Details - The CardiALLO Heart Failure Trial consists of a Phase I/II study with an open label Phase I nine-patient dose escalation cohort, followed by a thirty-patient randomized double-blinded placebo-controlled cohort [2][3] - The Phase I trial involves treating three patients at escalating doses of 20 million, 100 million, and 200 million cells, utilizing a minimally invasive delivery system [2][3] - A Data Safety Monitoring Board (DSMB) will review safety data after each dose cohort, with the first review expected in March 2025 [2][3] Treatment Mechanism - The "off the shelf" MSCs used in the study are believed to provide immunomodulatory benefits and promote microvascular repair, enhancing capillary density and reducing fibrosis in patients with inflammatory disease-mediated heart failure [3][4] - Previous clinical trials have shown safety and trends of efficacy for these allogeneic cells without the need for immunosuppression or causing arrhythmias [3] Future Prospects - The current study aims to position the CardiALLO MSC therapy for pivotal clinical studies in the U.S. and conditional approval in Japan [4] - Enhanced manufacturing capabilities for MSCs are expected to be commercially scalable, supporting potential partnerships for other indications [4]
BioCardia Reports Completion of Low Dose Cohort Enrollment for CardiALLO Phase I/II Clinical Trial of BCDA-03 Allogeneic Mesenchymal Stem Cells to Treat Ischemic Heart Failure of Reduced Ejection Fraction (HFrEF)