Tuesday, January 6, 2009

Find A Doctor

by location

by last name

by specialty

December 16, 2004 Midwest Heart Foundation conducts revolutionary gene therapy trial

Midwest Heart Foundation conducts revolutionary gene therapy trial for severe angina “GENASIS” researchers inject growth-factor gene directly into heart muscle

December 16, 2004
Midwest Heart Foundation is one of the first research centers in the nation to perform an experimental gene-transfer procedure believed to stimulate the growth of new blood vessels in heart tissue damaged by severe cardiovascular disease.

The gene therapy trial is the largest of its kind ever undertaken. Midwest Heart Foundation is one of a handful of medical centers in the Midwest and one of only about 20 in the U.S. invited to conduct this landmark study.

The trial is called GENASIS (Genetic Angiogenic Stimulation Investigational Study). It is a phase IIb, randomized, double-blind, dose-ranging and placebo-controlled study sponsored by Corautus Genetics, Inc.

GENASIS will test the safety and effectiveness of directly injecting into the heart muscle the genetic code of a protein “growth factor” that is believed to promote the development of collateral blood vessels—a process known as therapeutic angiogenesis.

The technology
The injection is done with a special cardiac catheter that precisely delivers the bone marrow-derived, growth-factor protein called Vascular Endothelial Growth Factor-2 (VEGF-2), to ischemic or oxygen-deprived areas of the heart. These areas lack adequate blood flow because of artery blockages from plaque.

In theory, the heart cells near the injection site take VEGF-2 DNA into their nuclei, triggering the production of specialized cells that play a key role in blood vessel formation—in turn, stimulating the growth of new “collateral” blood vessels that supplement the existing circulation. The increased blood flow provides more oxygen to the area, relieving angina and improving heart function.

Notably, preliminary studies report encouraging clinical improvements in exercise tolerance and angina symptoms in patients with severe coronary disease compared to patients who received a placebo.

Patient candidates
The patient entry criteria for GENASIS are stringent.

Midwest Heart Foundation, working in collaboration with Midwest Heart Specialists and Elmhurst Memorial Hospital, is enrolling patients in GENASIS, who have the most debilitating forms of angina (Class III and IV). They are “refractory” or unable to successfully benefit from conventional cardiovascular therapies, and experience chest pain or discomfort when they perform ordinary activities.

A physician can refer patients to the study or patients can refer themselves by contacting Midwest Heart Foundation toll-free at 1-866-MHF-RSCH (866-643-7724).

Clinical facts
According to the American Heart Association: Approximately 6.8 million coronary artery disease patients in the U.S. have angina. Those with Class III and IV angina have the most severe forms of the condition. Among this group, approximately 150,000 to 250,000 are annually diagnosed as “refractory,” meaning they cannot be successfully treated with conventional coronary therapies.

Midwest Heart Foundation is a nonprofit, research and education foundation that has conducted more than 250 clinical trials since it was established in 1988. Midwest Heart Specialists is a 57-physician cardiovascular practice with 15 offices located throughout Greater Chicagoland and northern Illinois. www.midwestheart.com