A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ad5FGF-4 in Female Patients with Stable Angina Pectoris Who Are Not Candidates for Revascularization
One aspect of coronary angiogenesis research is the study of growth hormones used to increase the blood supply to the heart. It is optimal to increase the blood supply to the heart because a decreased supply of blood to the heart, caused by narrowed or blocked arteries, may cause angina, also known as chest pain.
Gene therapy refers to the process in which DNA is introduced into cells. The DNA then directs those cells to produce a specific protein. This study delivers a fragment of DNA that produces a protein called FGF. FGF-4 is fibroblast growth factor-4, a growth hormone specific to arteries. FGF is naturally produced in the human body to start the growth of tiny arteries, called collateral vessels, in areas where blood flow is limited. By giving more of what your body produces naturally, growth hormones specifically designed to create blood vessels, we hope to improve the blood supply to the heart and decrease or eliminate angina.
The Minneapolis Heart Institute Foundation (MHIF) participated in the largest gene therapy trial (the Berlex AGENT-3 Trial) in the world ever done to promote growth of new blood vessels in the heart muscle (myocardial angiogenesis). There were 416 patients enrolled in this gene therapy trial from 66 different research centers across the United States. Overall, patients did have improvement in chest pain. MHIF was the highest enrolling site in the United States and Dr. Tim Henry presented the results at the annual American College of Cardiology meeting in March, 2005. All of our 39 patients enrolled at the Minneapolis Heart Institute Foundation were considered high risk and MHIF patients in the Ad5FGF-4 treatment groups (high dose and low dose) showed improvement in exercise time compared with patients in the placebo treated group and angina. Overall safety results for the AGENT-3 clinical study indicated that Ad5FGF-4 was well tolerated with no significant safety concerns.
The Research Continues: MHIF is currently participating in the AWARE study. This study intends to find out whether gene therapy using Ad5FGF-4 (investigational and experimental) can stimulate the growth of new blood vessels in the heart and benefit female patients with chest pain. In this study, the gene for FGF-4 (or placebo) will be delivered into a patient’s coronary arteries during a coronary angiogram. Patients will be required to follow up for clinic visits 1 week, 1, 3, 6, and 12 months after the procedure. 50 clinical sites will enroll 300 female patients into this clinical trial. This randomized study does include a placebo group and is double-blinded.
Meet the Research Team:
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