BioCardia, Inc., a leader in cellular therapies for cardiovascular diseases, has announced the completion of its pivotal Phase III trial for CardiAMP®, an autologous cell therapy designed to treat ischemic heart failure with reduced ejection fraction (HFrEF).
This milestone marks the last patient follow-up in the double-blind, placebo-controlled trial, which aims to assess the safety and effectiveness of the CardiAMP Cell Therapy System.
The trial, which enrolled 125 patients at 18 U.S. centers, randomized participants 3:2 to either the CardiAMP cell therapy treatment or a placebo.
This innovative therapy, designed for microvascular repair and reduced fibrosis, leverages a patient’s own marrow cells, delivered via a minimally invasive catheter-based procedure.
CardiAMP’s delivery approach holds potential to improve capillary density and restore damaged heart tissues.
Preliminary results from Phases I and II, as well as interim data from Phase III, indicated trends in improved patient outcomes, reduced hospitalization rates, and enhanced quality of life for those with advanced HFrEF.
Looking ahead, BioCardia is poised for regulatory engagement. The company plans to discuss the trial’s findings with the FDA to evaluate CardiAMP’s potential for broader approval.
Additionally, BioCardia has submitted a report to Japan’s Pharmaceutical and Medical Device Agency (PMDA) to evaluate CardiAMP based on U.S. data, with further consultations planned for November.
With an anticipated top-line release of trial data in early 2025, CardiAMP represents a significant development in stem cell therapies aimed at addressing unmet needs in ischemic heart failure.
More info about trial here: https://cardiamptrial.com/