Cardiovascular regenerative therapies specialist, BioCardia®, Inc., has announced positive 12-month results from its Phase II TRIDENT clinical trial.
BioCardia, with its Helix™ transendocardial system for the delivery of stem cells into the heart, was in the news in May. The system is designed to deliver a high dose of a patient’s own bone marrow cells directly to the point of cardiac dysfunction, the idea is to stimulate the body’s natural healing mechanism after a heart attack. Use of Helix resulted in 18 times higher retention of injected cells in the myocardium than intra-coronary artery infusion, as detailed here.
Today’s newly flagged study was concurrently published in Circulation Research – “Dose Comparison Study of Allogeneic Mesenchymal Stem Cells in Patients with Ischemic Cardiomyopathy (The TRIDENT Study)” – and presented on the podium at the Heart Failure Society of America (HFSA) Annual Scientific Meeting in a session entitled “Big Trials of Past Year” by Victoria Florea, MD of the Interdisciplinary Stem Cell Institute at the University of Miami.
The randomized, double-blinded Phase II trial encompassed 30 patients with chronic left ventricular (LV) dysfunction secondary to myocardial infarction. Half of the patients were randomized to receive a dosage of 20 million allogeneic mesenchymal stem cells (MSCs) and the other half received a dosage of 100 million cells.
The TRIDENT study demonstrates that human mesenchymal stem cells are clinically efficacious in reducing scar size and improving cardiac function.
Moreover, scar size reduction and functional restoration occurs at the sites of cell delivery. There were no treatment-emergent serious adverse events within the first 30 days or evidence of ectopic tissue formation at 12 months. The conclusion is a positive safety profile for allogeneic, or donor cell-based, mesenchymal stem cells delivered with the company’s Helix™ transendocardial delivery system at 30 days.
“We congratulate the team at the University of Miami on the completion of another important, world-class study, which follows their POSEIDON trial, which we were also proud to co-sponsor,” said BioCardia CEO Peter Altman, Ph.D. “We are encouraged by the safety outcome seen in this trial, which adds to the growing safety data supporting our transendocardial delivery system. We are also encouraged by the positive efficacy signals for allogeneic human mesenchymal stem cells derived from bone marrow, which we are developing for use in our second therapeutic approach, CardiALLO.”
Source: BioCardia, Inc.