NEW YORK – Emory University School of Medicine has begun enrolling patients with ischemic heart failure into the pivotal, Phase III CardiAMP HF II trial testing the efficacy of BioCardia's autologous cell therapy, the company announced last week.
Sunnyvale, California-based BioCardia is developing the CardiAMP Cell Therapy, for which the company harvests a patient's own bone marrow cells and delivers them to the heart via a catheter in a minimally invasive procedure. The treatment is designed to "stimulate the body’s natural healing response," according to BioCardia.
Emory University School of Medicine in Atlanta is the latest clinical trial site to begin enrolling ischemic heart failure patients in the CardiAMP HF II trial, which is testing the activity of the CardiAMP Cell Therapy compared to a placebo arm, in which patients will also receive guideline-directed treatment.
BioCardia launched this latest study to home in on a biomarker-defined subset of patients that appeared to benefit from its cell therapy in the earlier CardiAMP Heart Failure Study. BioCardia last year determined that first study, results from which it presented at the American College of Cardiology's annual meeting last month, was unlikely to show that the cell therapy bested the control arm based on a composite endpoint that factored in all-cause death, major adverse cardiac events, and improvement in a six-minute walking test.
However, researchers reported statistically significant improvements on a composite outcome measure that combined survival, major adverse cardiac events, and quality of life seen in patients who have active heart stress, as indicated by elevated levels of N-terminal pro B-type natriuretic peptide (NT-proBNP), a biomarker of cardiac failure and stress. The CardiAMP HF II study will specifically home in on these patients with active heart stress and track a composite endpoint comprising quality of life but not the six-minute walking test.
BioCardia said in a statement that it will share results from CardiAMP Cell Therapy trials with US and Japanese regulators on patients with elevated NT-proBNP, who may not benefit from existing treatment options.
"The screening for CD34-positive cell composition and high dosage being delivered in an interventional cardiology setting is in alignment with our own past research and enhances both my confidence in the results recently presented and the potential for treated patients to do well in the study ahead," Arshed Quyyumi, a professor of medicine in the cardiology division at Emory University School of Medicine and codirector of the Emory Clinical Cardiovascular Research Institute, said in a statement. "Our team at Emory is looking forward to offering patients with heart failure the opportunity to participate in this minimally invasive autologous cell therapy trial."