Stem cell implantation in the treatment of peripheral vascular disease

Abstract

Treatment options of ischemic vascular disease of the lower limbs are a challenged field that necessitates new therapeutic modalities. Stem cell transplantation offers a promising achievement of therapeutic angiogenesis in patients with ischemic limbs. Our study investigated the efficacy and safety of the implantation of autologous peripheral blood mononuclear cells (PBMNCs) mobilized by granulocyte colony-stimulating factor (G-CSF) in patients with chronic limb ischemia. Twenty-four patients with chronic lower limb ischemia were enrolled and divided randomly into two groups: the implanted group (n = 12) and the control group (n = 12). In the implanted group, the patients received subcutaneous injections of recombinant human G-CSF (300 μg/day) for 5 days to mobilize stem/progenitor cells, and their PBMNCs were harvested using a blood cell separator and were implanted by multiple intramuscular injections into the ischemic limbs, while the control group was injected with sterile saline and received conventional medical treatment. All patients were followed up after 12 weeks. At the end of the follow-up period, the main manifestations significantly improved in patients of the implanted group compared with the control group. The mean of rest pain decreased from the baseline level of 6.42 ± 2.15 to 1.67 ± 0.389 (P < 0.001). The mean of pain-free walking distance increased from 25.00 ± 8.90 to 409.00 ± 104.00 (P < 0.001). The mean ankle–brachial pressure index increased from 0.45 ± 0.12 to 0.79 ± 0.38 (P = 0.005). Seven out of nine limb ulcers and wounds (77.8 %) of implanted patients healed after cell implantation. Two lower limb amputations (16.67 %) occurred in the implanted patients. In contrast, eight control patients (66.67 %) had to receive lower limb amputation. Implantation of stem/progenitor cells is a feasible and readily available effective strategy for therapeutic angiogenesis in patients with chronic limb ischemia.