September 26, 2017 — BioCardia Inc. recently 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 and presented on the podium at the Heart Failure Society of America (HFSA) Annual Scientific Meeting, Sept. 16-19 in Dallas. Results were presented by Victoria Florea, M.D., 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; and
- Moreover, scar size reduction and functional restoration occurs at the sites of cell delivery.
For more information: www.biocardia.com