Enhancing limb salvage by non-mobilized peripheral blood angiogenic cell precursors therapy in patients with critical limb ischemia.

Background: Stem cell therapy has been proposed to enhance the salvage of critically ischemic limbs. Objective: Assess the efficacy and safety of the implantation of non-mobilized peripheral blood angiogenic cell precursors (NMPB-ACPs) in patients with critical limb ischemia (CLI) who were poor candidates for standard revascularization treatment options. Material and Method: Six patients with CLI due to the infrapopliteal artery occlusive disease were included in the present study. Intramuscular injections of NMPB-ACPs were administered in the ischemic limbs. The efficacy was evaluated by clinical outcomes, ankle brachial index, toe brachial index, and computerized tomographic angiography. Results: There was no evidence of local or systemic complication related to the procedure. Five patients (83.3%) had clinically significant improvement of adequate circulation at the distal limb for the complete healing. Four of them had complete healing of ischemic ulcers and stumps of toe amputation. However, one patient with adequate granulation tissue at the stump of the left first toe amputation subsequently suffered from severe foot infection originating from the other toes and eventually underwent below knee amputation. There was no improvement of circulation at the distal limb after the administration of NMPB-ACPs in one patient (16.7%) who eventually underwent major amputation. Conclusion: The preliminary result of NMPB-ACPs therapy may be safe and provide benefits in the improve- ment of circulation in patients with CLI. A larger controlled trial is required to ascertain these preliminary results.