Critical Limb Ischemia (CLI) – A Significant Market
Approximately 1 M people in the US suffer from Critical limb ischemia (CLI). This disease results in more than 160,000 amputations each year.
CLI is the term used for patients with chronic ischemic rest pain, ulcers, or gangrene that is attributable to inadequate blood flow or arterial occlusive disease. CLI is typically identified as the end stage of peripheral arterial disease. CLI is the most severe form of PAD, and is typically the end stage of the disease.
CLI is a severe obstruction of the arteries which decreases blood flow to the extremities (hands, feet and legs) and has progressed to the point of severe pain and even skin ulcers or sores. Patients with CLI often suffer from severe pain caused by ischemia, tissue loss, ischemic neuropathy or a combination of these factors. The pain typically occurs at night when the patient is resting, and episodes can last for hours.
A large percentage of patients with CLI have coexisting diseases, such as cardiovascular and renal disorders. CLI patients also are at high risk for myocardial infarction, stroke, and vascular death. Therefore, prompt referral to a specialized vascular center improves the success of their treatment and reduces the systemic risk in this population.
People with CLI face a high risk of amputation and in some cases death. No effective pharmacologic therapy is available, and amputation is often the only option left, but is associated with an even worse prognosis: perioperative mortality is 5% to 20% and a second amputation is required in 30% of all patients.
Aastrom Biosciences’ (NASDAQ:ASTM) positive and encouraging RESTORE-CLI P2b interim results provide a strong signal of the potential efficacy and safety of autologous cell therapy in patients with CLI. The final patient has been (3/24/10) treated in the P2b RESTORE-CLI P2b clinical trial.
