Results Presented for AMI Patients Treated Early With Cell Therapy Delivered Using Biocardia’s Helix System
June 3, 2019—BioCardia, Inc. announced the presentation of results from a study of the company’s Helix biotherapeutic delivery system for cell therapy used to treat patients early after acute myocardial infarction (AMI) to prevent long-term heart failure. Christina Paitazoglou, MD, presented the Alster-Helix registry findings during a Hot Line/Late Breaking Trials session of first-in-human trials and early phase studies at EuroPCR held May 21–24 in Paris, France.
The study was designed to determine if intramyocardial injection of autologous bone marrow–derived mononuclear cells using the Helix system 2 to 4 weeks after AMI is feasible, potentially block ventricular adverse remodeling, and improve symptoms of heart failure.
According to the company, nine patients were treated with cell therapy delivered intramyocardially with the Helix system. The results from these patients were reviewed relative to results of 11 patients previously treated with the Noga XP delivery system (Biosense Webster, Inc., part of Johnson & Johnson Medical Devices Companies) and a control group of 11 patients treated with optimal standard care.
The investigators reported that at 12 months, patients with Helix-delivered cell therapy experienced a 7.33% improvement in ejection fraction at 12 months (P = .017) compared with the control group; there were no 12-month data available for the Noga system at 12 months.
Additionally, Helix patients showed an improvement in New York Heart Association class of more than one class versus the control at 6 months (2.55 ± 0.1 vs 1.33 ± 0.1; P = .0078), which was greater than both the Noga-treated and control groups.
In the presentation at EuroPCR, Dr. Paitazoglou commented, “Results suggest that intramyocardial cell therapy possibly improves left ventricular function and symptoms by attenuating myocardial remodeling on top of successful percutaneous coronary intervention and optimal standard care after AMI. Results (for the Helix system) are similar to the Noga-treated patients, as previously observed in the ALSTER stem cell trial.”
This study, the first of the Helix system used with patients early after a heart attack to prevent heart failure, demonstrated very encouraging results that support the promise of Helix delivery of autologous bone marrow–derived cells to improve the lives of patients with cardiovascular disease, stated BioCardia.