The treatment, administered through a catheter, delivers a growth factor gene that triggers production of a protein to stimulate new blood vessel growth, a process known as angiogenesis. The newly formed vessels may provide alternate routes for blood to bypass clogged and blocked arteries that feed the heart, according to Jeffrey A. Brinker, M.D., director of interventional cardiology at Hopkins and principal investigator for the trial. Angiogenesis is a natural biological healing process, but the body's natural response is often insufficient to overcome injury caused by ischemia, or a lack of blood flow.
Gene therapy is designed to enhance the body's abilities to build new routes.
For the study, the interventional cardiology group is seeking patients with moderate chest pain and early signs of coronary artery disease. Patients should be able to exercise on a treadmill for at least three minutes. To evaluate the therapy's effects, researchers will have patients take part in treadmill exercise tests and stress echocardiography four and 12 weeks following treatment. The clinical trial is sponsored by Berlex Laboratories Inc., a subsidiary of Schering AG, Germany, in collaboration with Collateral Therapeutics of San Diego.