BioCardia, a leader in cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, announced that the University of Wisconsin School of Medicine and Public Health has enrolled its first patient in the company’s ongoing Phase 3 CardiAMP HF II clinical trial. The trial evaluates BioCardia’s CardiAMP cell therapy for patients with ischemic heart failure with reduced ejection fraction (HFrEF) who continue to show elevated markers of heart stress despite optimized medical therapy.
The CardiAMP HF II trial is a 250-patient randomized, multicenter, placebo-controlled study designed to assess the safety and efficacy of CardiAMP autologous cell therapy as a one-time treatment. The study aims to validate the positive outcomes observed in the prior CardiAMP HF study, where patients with elevated NTproBNP levels achieved statistically significant improvements in a three-tier composite endpoint consisting of all-cause mortality, non-fatal major adverse cardiac events, and quality of life measures.
The trial also incorporates key advancements, including the use of cell population analysis at screening to define treatment doses and improvements to BioCardia’s Helix biotherapeutic delivery system, featuring the FDA-approved Morph DNA steerable platform.
CardiAMP Cell Therapy, which has received FDA Breakthrough designation, utilizes a patient’s own bone marrow cells delivered directly into the heart via a minimally invasive, catheter-based procedure intended to increase capillary density and reduce tissue fibrosis, targeting microvascular dysfunction. The program’s clinical development is supported by the Maryland Stem Cell Research Fund and reimbursed by the Centers for Medicare and Medicaid Services (CMS).
Headquartered in Sunnyvale, California, BioCardia continues to advance its autologous and allogeneic cell therapy platforms—CardiAMP and CardiALLO—with three clinical-stage product candidates enabled by its Helix and Morph platforms.
KEY QUOTES:
“CardiAMP cell therapy has shown evidence of benefit for ischemic heart failure patients with elevated markers of heart stress, despite being on optimized medical therapy. We look forward to offering patients the opportunity to participate in this important study and potentially contributing to the evidence that may enable this therapy to be more broadly available.”
Dr. Amish Raval, M.D., Professor of Medicine at UW School of Medicine and Public Health and CardiAMP HF II Trial National Co-Principal Investigator
“We are pleased that the UW School of Medicine and Public Health has completed their first enrollment in our ongoing Phase 3 CardiAMP HF II clinical trial. The leadership of this prestigious cardiology center strengthens our trial. We share the vision of providing specialized medicine that translates into personalized care for improved patient outcomes. Dr. Amish Raval, who has served as our CardiAMP HF II Trial Co-National Principal Investigator since the trial’s inception, is a valued world leader in both basic science and translation of biotherapeutic interventions in cardiology. We are proud to partner with the University of Wisconsin, as well as our other CardiAMP HF II clinical sites, as they strive to provide the best in care for patients diagnosed with ischemic heart failure.”
Peter Altman, PhD, CEO of BioCardia
