Therapeutic angiogenesis in Buerger's disease (thromboangiitis obliterans) patients with critical limb ischemia by autologous transplantation of bone marrow mononuclear cells

Background: Peripheral arterial disease is a significant problem worldwide. In developing countries such as India, the increased incidence of smoking and other forms of nicotine intake has resulted in a large proportion of young individuals with Buerger's disease. The results of surgical and endovascular treatment for this condition have not been very, rewarding. Hence, we focused on providing alternative therapies. Neovascularization by autologous bone marrow mononuclear cell transplantation is being tried as an alternative therapeutic option. We have reviewed our series of patients who underwent autologous bone marrow mononuclear cell transplantation during the last 2 years. Methods: We enrolled 38 patients who were chosen to undergo autologous bone marrow mononuclear cell transplantation for nonreconstructible Buerger's disease. We injected the bone marrow mononuclear cells into the calf muscles of the affected limbs in 36 patients. We monitored ulcer healing, ankle-brachial index (ABI), and transcutaneous oximetry (TcPO(2)) level. Results: No procedurally related complications occurred, although one injected sample of bone marrow aspirate later revealed infestation with Strongyloides stercoralis. Two patients were seropositive on the Venereal Disease Research Laboratory test and were not injected with the bone marrow mononuclear cells. Three patients (12%) underwent major amputations <= 6 months. The others had improvements in their ulcer healing, an increase in the mean ABI of 0.14 (range, 0.1-0.19; P < .01), and improvement in the mean TcPO(2) of 52 mm Hg (range, 40-68 mm Hg, P < .01), with resultant limb salvage in all at 6 months. All patients discontinued smoking during the study period. Conclusions: Use of bone marrow-derived progenitor cell transplantation into ischemic limbs is a relatively safe procedure with no demonstrable side effects at 6 months. These study data support conducting controlled and multicenter trials to evaluate the efficacy of this therapy in preventing amputation in selected patients with Buerger's disease who have critical limb ischemia. (J Vasc Surg 2008;48:53S-60S.)