TABMMI Heart Failure Stem Cell Clinical Trial Results Presented; Improvements Sustained at Three Year Follow-up
San Carlos, CA - March 10, 2009
BioCardia announces scientific presentation of clinical results at the 2009 Cardiac Research Technologies meeting in Washington DC. The presentation entitled: ”Three Year Follow-up in an Open-Label, Pilot Study of Transendocardial Autologous Bone Marrow in Chronic Myocardial Infarction (TABMMI) using a Helical Needle Catheter” presented data by investigator Dr. Luis de la Fuente.
In this BioCardia sponsored Phase I trial, cells are taken from the patient’s own bone marrow before being processed and re-administered at target sites near damaged tissue in the heart. The use of the patient’s own cells, known as autologous therapy, avoids the problems of rejection that are common in many cell and organ transplantation procedures. In published basic science studies these cells have been shown to promote the growth of blood vessels, 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. This delivery system avoids the risk of open chest surgical delivery that is of significant in this patient population.
The presentation reported on the first ten patients treated with three year follow-up and provided preliminary results on all twenty patients treated to date. Results are positive, as all patients were discharged within 24 hours of therapy with no safety issues associated with therapy, and patients at three years have shown functional increases in the efficiency of their heart function as well as improvements in exercise tolerance. The last patient follow-up for this trial is scheduled for later this month, and final results on all twenty patients will be submitted to peer reviewed scientific journals for publication.
BioCardia is encouraged with these results as they suggest better outcomes may be achieved through direct delivery to the heart than from the delivery of cells to the arteries feeding the heart. Extensive animal data shows that BioCardia’s Helical Infusion Catheter system has ten to twenty times the delivery efficiency by delivering directly into the heart tissue from within the heart. This delivery is also targeted to diseased regions where the blood vessels often cannot reach because of the disease.
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. Therapies today for these patients are limited. Stem cell therapy in this population has shown enormous promise to provide benefit to patients.