Angiogenic gene therapy: pre-clinical studies and phase I clinical data.

Over the last three decades, significant progress has been made in the management of patients with atherosclerotic coronary and peripheral vascular diseases using medical, surgical, and percutaneous therapies. Despite these advances, there remains a significant population of patients who are not optimal candidates for surgical or percutaneous revascularization. These patients continue to suffer from the debilitating symptoms of their disease and remain at risk for myocardial infarction, limb loss, or death. It was this clinical need, coupled with the advances in the understanding of angiogenesis, that has led to efforts to develop angiogenic therapies for patients with peripheral and myocardial ischemia. In general, these conditions are characterized by local hypovascularity, and the approach to treatment is therefore focused on stimulating neovascularization.