Progenitor cell therapy in patients with critical limb ischemia without surgical options

Objective: To provide a review on progenitor cell therapy for critical limb ischemia. Summary Background Data: Critical limb ischemia is estimated to develop in 500 to 1000 individuals per million persons per year and has a major impact on the quality of life. Despite recent advances in surgical and radiologic vascular procedures, a large number of patients (∼40%) are not eligible for these revascularization procedures. New strategies for revascularization need to be explored. Recent evidence indicates that bone marrow-derived mononuclear cells are a potential new therapeutic target. Methods: A comprehensive review of all published literature on progenitor cell therapy in patients with critical limb ischemia was performed. Results: Twenty-five clinical studies that reported on the use of mononuclear cells or progenitor cells for the treatment of patients with critical limb ischemia have been published, of which 18 were included in this review. Seven studies were published in Chinese, Japanese, or Polish and, therefore, not included. Conclusions: Pioneering clinical studies report promising results for progenitor cell-based therapies for chronic limb ischemia, but no definite proof is available because the clinical studies thus far have been small and lacked double-blinded controls. Larger, randomized, blinded, placebo-controlled trials to investigate the potential clinical effects of bone marrow progenitor cell administration in patients with critical limb ischemia are needed.