[Stem cells and cardiovascular therapy: results in peripheral artery disease]

Critical leg ischemia (CLI) remains a major cause of mortality and morbidity (amputation), and its treatment is a major challenge. Cell therapy designed to stimulate angiogenesis is being evaluated in this setting. Several phase III trials have demonstrated that it is safe and feasible to use autologous bone marrow mononuclear cells or peripheral mononuclear cells harvested after G-CSF stimulation. Three trials with more than 40 patients have been performed in France, and more than 700 patients have been treated worldwide, usually in non controlled trials. The main problems encountered with cell therapy in CLI are not only the need to demonstrate its efficacy and safety, but also to identify the patient categories most likely to benefit. The results of randomized trials, and especially the French BALI trial, are eagerly awaited to confirm that this approach is really beneficial. Afew trials have also been performed in Buerger's disease. Another exciting possibility is to create artificial vessels in vitro for subsequent grafting in patients with no available venous grafts. Several teams are also testing allogeneic stem cells and autologous progenitor endothelial cells for the treatment of peripheral artery disease but they are encountering significant hurdles.