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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)
Focus on Patients with Elevated Markers of Heart Stress and Inflammation Procedural enhancement using FDA Approved Morph DNA steerable guide for therapeutic
About this update from Biocardia, Inc.
[{"type":"text","content":"Focus on Patients with Elevated Markers of Heart Stress and Inflammation Procedural enhancement using FDA Approved Morph DNA steerable guide for therapeutic delivery SUNNYVALE, Calif., Feb. 13, 2025 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced today completion of enrollment and dosing in the low dose cohort in its CardiALLO™ Allogeneic Mesenchymal Cell Therapy Phase I/II trial. The trial is designed to treat patients with ischemic heart failure of reduced ejection fraction (HFrEF) and is believed to be the world’s first prospective trial of allogeneic mesenchymal stem cells (MSC) intended for treating HFrEF patients having elevated markers of heart stress and systemic inflammation. “This novel investigational cell therapy has great potential to help these patients, who suffer from significant lifestyle limitations despite receiving guideline directed medical therapy,” said Carl Pepine, M.D., Professor of Medicine at the University of Florida Division of Cardiovascular Medicine at Gainesville, and National Principal Investigator for the study. “The higher dosing and precision medicine for patients most likely to be responsive to this novel allogeneic therapy are very promising enhancements.” “The treatment procedures have gone well, and we look forward to the first independent safety review,” said R. David Anderson, M.D., Professor of Medicine in the University of Florida Division of Cardiovascular Medicine and the Director of Interventional Cardiology and Cardiac Catheterization, and Principal Investigator for the study at the University of Florida at Gainesville. “As part of this therapy, we are utilizing the Morph DNA guide to navigate, enhancing physician control for cell delivery. Based on experience to date in this study, it is a compelling product improvement.” The CardiALLO Heart Failure Trial is 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 procedure-controlled cohort, intended to develop support for safety and efficacy of this treatment. For Phase I, three patients are to be treated at one of three escalating doses of 20 million cells, 100 million cells, and 200 million cells, using BioCar...