BioCardia Begins Phase 3 CardiAMP HF II Trial for Heart Failure Treatment

On May 1, 2025, BioCardia, Inc., a prominent firm specializing in cellular therapies for cardiovascular and pulmonary diseases, unveiled the enrollment of the first patient in their CardiAMP HF II clinical trial. This Phase III trial, being conducted at BayCare Morton Plant Hospital in Clearwater, Florida, is meticulously designed as a double-blind, placebo-controlled study that evaluates the efficacy of the company's primary autologous cell therapy program in treating heart failure.

Dr. Leslie Miller, a leading physician at BayCare Morton Plant Hospital, expressed enthusiasm about spearheading the CardiAMP HF II trial. The study offers heart failure patients an innovative cell therapy known to improve microvascular function, with positive clinical results previously noted in the CardiAMP HF trial. As a Principal Investigator and part of the Executive Steering Committee, Dr. Miller emphasized the therapy's personalized approach, leveraging a patient's own cellular attributes to treat heart failure. This personalization eliminates the necessity for immune suppression and allows for repeated cell therapy, preserving all therapeutic options for patients. He extended gratitude to his team for reaching this significant milestone of enrolling the first patient in what is the pioneering Phase III confirmatory cardiac cell therapy trial for heart failure.

Dr. Rakesh Sharma, also involved in the trial, reported that the first procedure under the CardiAMP HF II study was executed smoothly and adhered to protocol. His extensive experience in cardiac cell therapy supports the potential of CardiAMP therapy, which involves the harvesting, processing, and delivery of cells into the heart muscle. Dr. Sharma praised the Helix minimally invasive delivery platform for its precision and the Morph DNA steerable catheter for its advanced design.

BioCardia's CEO, Peter Altman, Ph.D., expressed appreciation for the contributions of the BayCare Morton Plant team and other clinical teams worldwide engaged in CardiAMP trials. He mentioned ongoing preparations for regulatory submissions in Japan and the USA, aimed at securing separate approvals for the CardiAMP therapy and Helix delivery platform. The CardiAMP HF II trial is a crucial step in gathering confirmatory evidence to aid in approvals, adoption, and reimbursement of this autologous cell therapy.

The CardiAMP HF II trial involves 250 patients and is a multicenter study testing the CardiAMP autologous cell therapy as a one-time intervention for patients with ischemic heart failure and reduced ejection fraction on standard medical therapy. This trial aims to validate the safety and efficacy results observed in previous CardiAMP HF studies, focusing on patients with elevated NTproBNP. The study employs a three-tier composite primary outcome measure, similar to previous trials, but introduces a new quality of life self-assessment tool for patients.

Innovations in the CardiAMP HF II include cell population analysis during screening to determine treatment doses, broadening patient eligibility, and enhancements to the Helix system, notably the FDA-approved Morph DNA steerable platform. The CardiAMP Cell Therapy, recognized with FDA Breakthrough designation, uses a patient’s bone marrow cells in a catheter-based procedure to potentially boost the body's natural healing by increasing capillary density and reducing tissue fibrosis. It targets mechanisms of microvascular dysfunction through the production of various growth factors and cytokines.

The CardiAMP clinical development, supported by the Maryland Stem Cell Research Fund and reimbursed by the Centers for Medicare and Medicaid Services (CMS), represents BioCardia’s commitment to advancing therapies for heart failure. BioCardia, headquartered in Sunnyvale, California, remains a leader in therapeutic innovations for cardiovascular and pulmonary conditions, with its CardiAMP autologous and CardiALLO allogeneic therapies at the forefront.