Critical limb ischemia and stem cell research: anchoring hope with informed adverse event reporting.

Critical limb ischemia (CLI) represents a syndrome that is associated with a particularly adverse natural history. Although clinicians increasingly recognize that peripheral arterial disease (PAD) includes a broad range of clinical syndromes, CLI is associated with very adverse short-term limb and systemic cardiovascular outcomes.1 CLI is not a specific disease per se; rather, it represents a syndrome that may develop from many fundamentally distinct pathophysiological processes, including advanced atherosclerosis, thromboembolism or atheroembolism, in situ thrombosis, and the arteritides, such as thromboangiitis obliterans (TAO, or Buerger disease).