BioCardia Announces Publication of 12-Month Results from Phase II TRIDENT Clinical Trial That Shows Positive Safety Profile for Allogeneic Bone Marrow Stem Cells Delivered with Helix Transendocardial Delivery System
September 19, 2017
Results Concurrently Published in Circulation Research and Unveiled on Podium at Heart Failure Society of America (HFSA) Annual Scientific Meeting
DALLAS and SAN CARLOS, Calif. –BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced 12-month results from the Phase II TRIDENT clinical trial, conducted by the University of Miami Miller School of Medicine and co-sponsored by the company. The results showed 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. The 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 Circulation Research article highlights the following:
• The primary objective of this study was to determine the safety of the two doses of allogeneic MSCs, and this trial supports that transendocardial stem cell injection of these cells is safe, as there were no treatment-emergent serious adverse events within the first 30 days or evidence of ectopic tissue formation at 12 months.
• 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.
“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.”
BioCardia, Inc., headquartered in San Carlos, CA, is developing regenerative biologic therapies to treat cardiovascular disease. CardiAMP® and CardiALLO® cell therapies are the company’s biotherapeutic product candidates in clinical development.
Forward Looking Statements
This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. Such factors include, among others, the inherent uncertainties associated with developing new products or technologies, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardia’s business and product development plans and overall market conditions. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements.
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