BioCardia, Inc. has announced the completion of the last protocol-specified follow-up visit in its Phase III CardiAMP HF trial. This randomized, double-blind, placebo procedure-controlled, multi-center pivotal clinical trial is evaluating the CardiAMP Cell Therapy System for the treatment of heart failure with reduced ejection fraction (HFrEF).
The CardiAMP HF Trial enrolled 115 advanced HF patients on guideline-directed medical therapy (GDMT) across 18 hospitals in the United States. Participants were randomized 3:2 to either the CardiAMP autologous cell therapy treatment arm or a procedure placebo control arm. The trial is designed to assess the therapy's potential to reduce all-cause death and future hospitalizations, enhance functional capacity, and improve symptoms and quality of life for HF patients. The outcomes analysis of the randomized cohort will soon take place with primary effectiveness follow-up ranging from 12 to 24 months. The trial also includes an open-label roll-in cohort of ten patients, bringing the total number of patients to 125.
Addressing a Critical Unmet Need
HFrEF, an end-stage of ischemic heart disease, affects over a million U.S. patients and millions more worldwide. Despite advances in therapy, premature death, recurrent hospitalizations, and deteriorating quality of life remain significant burdens for patients, families, and healthcare systems.
CardiAMP Cell Therapy: A Novel Approach
The CardiAMP Cell Therapy System, which has received Breakthrough Device Designation from the FDA, involves a minimally invasive, catheter-based procedure to deliver a patient's own marrow cells to the heart. This therapy aims to promote microvascular repair through enhanced capillary density and reduced fibrosis, effects demonstrated in preclinical models.
According to Peter Altman, PhD, CEO of BioCardia, Phase I and II trial results, along with interim Phase III trial results, have indicated trends toward patient benefit across most outcome measures. He stated, "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."
Upcoming Milestones
Close-out visits and data monitoring with source data verification are expected to be completed this quarter. Final data transfer to the independent Statistical Data Analysis Core at the University of Wisconsin is anticipated soon thereafter. Top-line results are expected to be released in the first quarter of 2025.
BioCardia has submitted the Annual Report for the CardiAMP Heart Failure Trial to the FDA, detailing plans for completing patient follow-up, and intends to request a meeting with the FDA to discuss the results regarding the approvability of the CardiAMP Cell Therapy System. The company has also completed a supplementary submission to Japan’s Pharmaceutical and Medical Device Agency (PMDA), providing answers to PMDA’s previous responses on the approvability of the CardiAMP Cell Therapy System based on U.S. data, and has requested a consultation scheduled for late November. This consultation will prepare for a subsequent clinical consultation with PMDA after the results from the CardiAMP Heart Failure Trial are available.
Mechanism of Action
CardiAMP Cell Therapy targets 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. The therapy incorporates a pre-procedural cell population analysis for patient selection and treatment planning, a high target dosage of cells, and a proprietary delivery system designed for safer and more effective cell retention.
