BioCardia announced that Emory University School of Medicine is enrolling patients in the Phase III CardiAMP HF II trial, evaluating the CardiAMP Cell Therapy for ischemic heart failure. The therapy involves harvesting, processing, and minimally invasively delivering a patient’s own mononuclear cells to their heart to improve microvascular density and reduce fibrosis. The trial compares this treatment to a placebo procedure, with all participants receiving standard medical therapy.
This trial expansion is crucial because it brings a highly respected institution and a leading expert in interventional cardiology into the fold. Emory’s involvement, under the leadership of Dr. Arshed Quyyumi, is expected to accelerate patient enrollment and potentially strengthen the study’s findings. Positive results could significantly advance the field of heart failure treatment, especially for patients who don’t respond well to current medications. Dr. Quyyumi’s confidence in the therapy, based on promising earlier trial data presented at the American College of Cardiology Scientific Sessions, further underscores the trial’s potential.
CardiAMP Cell Therapy, which has received Breakthrough Designation from the FDA, involves a patient-specific cell analysis, a high cell dosage, and a proprietary delivery system designed for better cell retention and safety. Earlier trials have indicated trends toward improved survival, reduced major adverse cardiac events, and better quality of life. The CardiAMP HF II trial focuses on patients with elevated NTproBNP and BNP biomarkers, indicative of active heart stress, who showed significant positive responses in a previous study. BioCardia aims to submit the final results to the FDA and Japan’s Pharmaceutical and Medical Device Agency for potential approvals of both the CardiAMP Cell Therapy and the Helix delivery system.
Positive results from the CardiAMP HF II trial could lead to a much-needed new treatment option for heart failure patients, particularly those with elevated cardiac stress markers. This could shift the treatment paradigm, offering a minimally invasive approach that harnesses the body’s natural healing capacity. Approval of the Helix delivery system could also open doors for other biotherapeutic applications in the future, expanding its impact beyond this specific cell therapy.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
