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Autologous Transplantation of Granulocyte Colony–Stimulating Factor–Mobilized Peripheral Blood Mononuclear Cells Improves Critical Limb Ischemia in Diabetes

¹ National Research Center for Stem Cell Engineering and Technology, State Key Laboratory of Experimental Hematology, Institute of Hematology & Hospital of Blood Diseases, Chinese Academy of Medical Sciences & Peking Union of Medical College, Tianjin, China
² TEDA Center of Life Science & Technology, Tianjin, China

Address correspondence and reprint requests to Dr. Zhong Chao Han, Institute of Hematology & Hospital of Blood Diseases, Chinese Academy of Medical Sciences & Peking Union of Medical College, 288 Nanjing Rd., Tianjin, 300020, China. E-mail: tihzchan{at}public.tpt.tj.cn

OBJECTIVE— To assess the application of autologous transplantation of granulocyte colony–stimulating factor (G-CSF)–mobilized peripheral blood mononuclear cells (PBMNCs) in the treatment of critical limb ischemia (CLI) of diabetic patients and to evaluate the safety, efficacy, and feasibility of this novel therapeutic approach.

RESEARCH DESIGN AND METHODS—Twenty-eight diabetic patients with CLI were enrolled and randomized to either the transplant group or the control group. In the transplant group, the patients received subcutaneous injections of recombinant human G-CSF (600 µg/day) for 5 days to mobilize stem/progenitor cells, and their PBMNCs were collected and transplanted by multiple intramuscular injections into ischemic limbs. All of the patients were followed up after at least 3 months.

RESULTS—At the end of the 3-month follow-up, the main manifestations, including lower limb pain and ulcers, were significantly improved in the patients of the transplant group. Their laser Doppler blood perfusion of lower limbs increased from 0.44 ± 0.11 to 0.57 ± 0.14 perfusion units (P < 0.001). Mean ankle-brachial pressure index increased from 0.50 ± 0.21 to 0.63 ± 0.25 (P < 0.001). A total of 14 of 18 limb ulcers (77.8%) of transplanted patients were completely healed after cell transplantation, whereas only 38.9% of limb ulcers (7 of 18) were healed in the control patients (P = 0.016 vs. the transplant group). No adverse effects specifically due to cell transplantation were observed, and no lower limb amputation occurred in the transplanted patients. In contrast, five control patients had to receive a lower limb amputation (P = 0.007, transplant vs. control group). Angiographic scores were significantly improved in the transplant group when compared with the control group (P = 0.003).

CONCLUSIONS—These results provide pilot evidence indicating that the autologous transplantation of G-CSF–mobilized PBMNCs represents a simple, safe, effective, and novel therapeutic approach for diabetic CLI.

Abbreviations: ABI, ankle-brachial pressure index • CLI, critical limb ischemia • EPC, endothelial progenitor cell • G-CSF, granulocyte colony–stimulating factor • PAD, peripheral arterial disease • PBMNC, peripheral blood mononuclear cell

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