The University of California, San Diego Medical Center is the first hospital in California to enroll patients in a multi-center clinical trial, sponsored by Angioblast Systems Inc., to examine the safety and feasibility of administering adult stems cells to treat congestive heart failure.
The cells, derived from bone marrow, are injected by a catheter directly into the heart muscle. Sixty patients will be recruited for this clinical trial through UC San Diego Medical Center and hospitals nationwide.
“This Phase 2 clinical trial will evaluate whether or not adult stems cells can be targeted to the heart muscle to repair and help improve cardiac function in patients with severe heart disease,” said Anthony DeMaria, M.D., director of the Sulpizio Family Cardiovascular Center at UC San Diego Medical Center. “The hope is to identify an effective, minimally-invasive treatment for the growing numbers of patients in the U.S. who suffer from advanced heart failure and have no other treatment alternatives.”
Heart failure, which affects more than five million patients in the United States, is a condition in which the heart progressively loses its ability to pump blood throughout the body. Heart failure patients often have a history of prior heart attack and underlying disorders such as narrowing and hardening of the arteries, high blood pressure, and arrhythmia or irregular heartbeat.
The stem cells used in this clinical trial are derived from the bone marrow of an adult donor. Angioblast Systems Inc. of New York has identified a population of stem cells which may stimulate the regrowth of a patient's own heart muscle cells and blood vessels. This cell type is selected and prepared from a universal donor, expanded into large numbers, and injected into a recipient. The cells can be used in unrelated recipients because they do not activate the immune system.
Before the cells are injected into the patient's heart, a three-dimensional color-coded map is made of the heart's left ventricle, where the pumping action takes place. Using a technology called the NOGA XP Cardiac Navigation System, a visual is created which identifies the electric signals of the heart. By assessing the living and scarred areas, physicians can identify diseased tissue and then guide the injection catheter with pinpoint accuracy to the desired location.