BioCardia, Inc. has announced the completion of its Phase III CardiAMP HF trial, a randomized, double-blind, placebo-controlled study assessing the safety and effectiveness of the CardiAMP Cell Therapy System for heart failure with reduced ejection fraction (HFrEF). The trial, conducted across 18 hospitals in the United States, enrolled 115 patients with advanced HFrEF on guideline-directed medical therapy (GDMT). Patients were randomized in a 3:2 ratio to receive either the CardiAMP autologous cell therapy or a placebo procedure.
The primary effectiveness follow-up ranged from 12 to 24 months. The study also included an open-label roll-in cohort of ten patients, bringing the total number of patients to 125.
Addressing Unmet Needs in Heart Failure
HFrEF, a late-stage manifestation of ischemic heart disease, affects millions worldwide. Despite advancements in medical therapy, patients continue to face premature death, recurrent hospitalizations, and a decline in quality of life. The CardiAMP Cell Therapy System, which has received Breakthrough Device Designation from the FDA, represents a potential new approach to address these unmet needs.
The therapy involves a minimally invasive, catheter-based procedure to deliver a patient's own bone marrow cells to the heart. The goal is to stimulate microvascular repair by increasing capillary density and reducing fibrosis, mechanisms previously demonstrated in preclinical models.
Mechanism of Action and Clinical Development
The CardiAMP Cell Therapy targets the mechanisms that lead to microvascular dysfunction, including fibrotic, inflammatory, apoptotic, and endothelial autonomic dysfunction, largely through the production of growth factors, cytokines, chemokines, and other factors that directly counteract each of these mechanisms.
According to Peter Altman, PhD, CEO of BioCardia, previous Phase I and II trials, along with interim Phase III results, have indicated trends toward patient benefit across various outcome measures. "These results support our belief that the CardiAMP autologous, minimally invasive, cell therapy has great promise to provide a meaningful benefit for patients suffering from heart failure," Altman stated.
Trial Details and Next Steps
The CardiAMP Cell Therapy System incorporates a pre-procedural cell population analysis for patient selection and treatment planning, a high target dosage of cells, and a proprietary delivery system. Close-out visits and data monitoring are expected to be completed this quarter, with final data transfer to the independent Statistical Data Analysis Core at the University of Wisconsin soon after. BioCardia anticipates releasing top-line results in the first quarter of 2025.
BioCardia has submitted the Annual Report for the CardiAMP Heart Failure Trial to the FDA and intends to request a meeting to discuss the results and the potential approvability of the CardiAMP Cell Therapy System. The company has also engaged with Japan's Pharmaceutical and Medical Device Agency (PMDA) regarding the therapy's potential approval in Japan.
