COLUMBUS, Ohio – A new clinical trial at The Ohio State University Wexner Medical Center and Richard M. Ross Heart Hospital is using gene therapy in a new approach to help those suffering from chronic angina (chest pain) who can't undergo stenting or coronary bypass surgery.
The Ohio State Wexner Medical Center is one of 11 sites nationwide and the only one in central Ohio to participate in this research, which provides hope for patients. Angina is chest pain or discomfort that happens when the heart doesn't get as much blood and oxygen as it needs.
In the clinical trial, Ohio State cardiac surgeons inject an experimental gene therapy drug into the muscle tissue of a patient's heart. It's designed to boost a naturally-existing protein to promote growth of new blood vessels and improve blood flow in the heart. The minimally invasive procedure allows patients to go home after a brief hospital stay.
"Research in gene therapy has been around for decades and has safely been used to treat a wide range of diseases such as cancer, cystic fibrosis, diabetes and AIDS. We're just now starting to see more cardiovascular research in this area, and gene therapy treatment for refractory angina is completely new – there's nothing like this anywhere in the world. We're pleased that our team was chosen to participate in this groundbreaking clinical trial, which is providing hope for patients in improving their quality of life," said Dr. Nahush Mokadam, division director of Cardiac Surgery at the Ohio State Wexner Medical Center and local principal investigator of the clinical trial. Angina affects millions of adults and often is a symptom of coronary heart disease. Discomfort can be in the chest, shoulders, arms, neck, jaw or back. Triggers are stress, smoking, extreme heat and cold, heavy meals and excessive alcohol consumption. Angina often happens with physical activity and can usually be controlled by rest and medication. Patients with chronic angina continue to have problems even after taking medicine or undergoing procedures such as coronary bypass surgery or insertion of stents to keep arteries open.
Sponsored by XyloCor, the EXACT trial is a phase 1/2 multicenter, open-label, single arm, dose escalation trial. Participation includes nine clinic visits during the first six months and a final visit one year after receiving the study drug.
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