News | Stem Cell Therapies | September 26, 2017

BioCardia Announces 12-Month Results from TRIDENT Trial of Stem Cell Delivery System

Results show positive safety profile for allogeneic bone marrow stem cells delivered with Helix transendocardial delivery system

BioCardia Announces 12-Month Results from TRIDENT Trial of Stem Cell Delivery System

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

Related Content

News | Cardiovascular Clinical Studies | November 26, 2019
November 26, 2019 — The University of Connecticut (UConn) Department of Kinesiology and Hartford Healthcare have sele
FDA Issues Final Guidance on Live Case Presentations During IDE Clinical Trials
News | Cardiovascular Clinical Studies | July 10, 2019
The U.S. Food and Drug Administration (FDA) issued the final guidance “Live Case Presentations During Investigational...
Veradigm Partners With American College of Cardiology on Next-generation Research Registries
News | Cardiovascular Clinical Studies | July 03, 2019
The American College of Cardiology (ACC) has partnered with Veradigm, an Allscripts business unit, to power the next...
New FDA Proposed Rule Alters Informed Consent for Clinical Studies
News | Cardiovascular Clinical Studies | November 19, 2018
The U.S. Food and Drug Administration (FDA) is proposing to add an exception to informed consent requirements for...
A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development. #SCAI, #SCAI2018

A key slide from Elnabawi's presentation, showing cardiac CT plaque evaluations, showing the impact of psoriasis medication on coronary plaques at baseline and one year of treatment. It shows a reversal of vulnerable plaque development.  

Feature | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 – New clinical evidance shows common therapy options for psoriasis (PSO), a chronic inflammatory skin di
Intravenous Drug Use is Causing Rise in Heart Valve Infections, Healthcare Costs. #SCAI, #SCAI2018
News | Cardiovascular Clinical Studies | May 14, 2018
May 14, 2018 — The opioid drug epidemic is impacting cardiology, with a new study finding the number of patients hosp
Patient Enrollment Completed in U.S. IDE Study of THERMOCOOL SMARTTOUCH SF Catheter
News | Cardiovascular Clinical Studies | March 15, 2018
March 15, 2018 –  Johnson & Johnson Medical Devices Companies announced today that Biosense Webster, Inc., who wo
Lexington Begins HeartSentry Clinical Trial
News | Cardiovascular Clinical Studies | February 20, 2018
February 20, 2018 – Lexington Biosciences, Inc., a development-stage medical device company, announced the commenceme
Endologix Completes Patient Enrollment in the ELEVATE IDE Clinical Study
News | Cardiovascular Clinical Studies | February 06, 2018
February 6, 2018 – Endologix, a developer and marketer of treatments for aortic disorders, announced the completion o
12-Month Results from Veryan Medical's MIMICS-2 IDE Study Presented at LINC
News | Cardiovascular Clinical Studies | February 01, 2018
February 1, 2018 – Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS
Overlay Init