Gene therapy in critical limb ischemia

Critical limb ischemia (CLI) represents the most severe stage of atherosclerotic lower extremity peripheral artery disease (PAD), and CLI prevalence is expected to increase as the population ages. The current standard of care for CLI relies on direct revascularization, either by endovascular techniques or open surgical approaches, as there are few effective medical treatments for this condition. Therapeutic angiogenesis is a novel approach to improving limb outcomes for these patients. Experimental preclinical studies and phase I/II clinical trials of therapeutic angiogenesis using gene transfer in patients with CLI unsuitable for revascularization have shown promising results. In this review, we describe the potential clinical impact of this new approach as an adjunct in our therapeutic armamentarium.