Endpoint Assessment for Cell Therapy in Patients with Intermittent Claudication and Critical Limb Ischemia
Peripheral artery disease (PAD) affects over eight million Americans and is associated with significant morbidity and mortality as it is a marker of subclinical heart disease and systemic atherosclerosis (Rooke TW et al. J Am Coll Cardiol 2011;58:2020-2045). Patients with PAD are at increased risk for myocardial infarction, stroke, and death (Rooke TW et al. J Am Coll Cardiol 2011;58:2020-2045; European Stroke O et al. Eur Heart J 2011;32: 2851-2906; Jaff MR, Cahill KE, Yu AP, Birnbaum HG, Engelhart LM. Ann Vasc Surg 2010;24:577-587). PAD can be silent, however when symptomatic it is associated with a significant reduction in quality of life and, in its most sobering form, limb amputation (Rooke TW et al. J Am Coll Cardiol 2011;58:2020-2045; European Stroke O et al. Eur Heart J 2011;32: 2851-2906). Given its substantial health burden, PAD has become the focus of many therapeutic developments including drugs, surgical revascularization, endovascular devices, and emerging gene and cellular therapies discussed in this book.