Press Releases
TAC-HFT Stem Cell Trial Treats First Heart Failure Patient
October 30, 2008
BioCardia announces that physicians at the University of Miami have successfully treated the first patient in the Transendocardial Autologous Cells in Heart Failure Trial (TAC-HFT). A total of sixty eight patients are to be enrolled in this blinded and randomized trial of adult stem cells to treat this chronic disease.
In this trial, cells are taken from the patient’s own bone marrow before being processed and readministered at target sites near damaged tissue in the heart. The immune system will not attack the newly transplanted autologous cells, a common problem in many cell and organ transplantation procedures, as they are native to the patient. In published basic science studies these cells have been shown to promote the growth of blood vessels, the formation of heart precursor cells, and improve heart function.
The investigational cell based biologic therapy is delivered to the patient’s heart through a two part catheter system that is inserted into a small puncture site in a leg artery. The two part catheter system includes the FDA cleared Morph® deflectable guide catheter which provides navigation and guidance, and a smaller investigational Helix™ catheter which enables precise and controlled delivery of cells to the heart.
TAC-HFT builds on the previous experience obtained in the Phase I Transendocardial Autologous Bone Marrow in Myocardial Infarction (TABMMI) trial that treated twenty patients at two centers in Buenos Aires, led by principle investigator, Dr. Luis de la Fuente. The published TABMMI results have supported the safety of the procedure with patients showing sustained benefits.
TAC-HFT is led by a world class team at the University of Miami, including: Principle Investigator and Chief of Cardiology, Dr. Joshua Hare, Interventional Investigator and Chief of Clinical Cardiology, Dr. Alan Heldman, and Director of Experimental and Clinical Cell-Based Therapies Program, Dr. Ian McNiece.
Heart failure is a disease of increasing concern with 550,000 new patients each year and a prevalence of 5,200,000 patients suffering from this disease in the United States. Fifty percent of all hospital admissions in patients over 65 years of age in the United States are for cardiac failure. It is a significant economic burden, and therapies today for these patients are limited. Stem cell therapy in this population has shown enormous promise to provide benefit to patients.
A video clip is available on the first TAC-HFT patient by following the link: http://video.nbc6.net/player/?id=786401.
About BioCardia
Founded in 1999 and headquartered in South San Francisco, privately held BioCardia, Inc. is a leader in cardiac regeneration therapies. BioCardia is the corporate sponsor of the TAC-HFT and TABMMI stem cell trials. BioCardia provides Helix™ and Morph® catheter systems to partners for other leading biological based therapies to treat cardiovascular disease. BioCardia also markets the Morph® catheter directly to interventional cardiologists, cardiac electrophysiologists, vascular surgeons, and interventional radiologists at more than 200 hospitals in the United States. More information available at: www.biocardia.com. Contact: Miranda Peto 650-624-0900 mpeto@biocardia.com.
