Chinese Journal of Tissue Engineering Research ›› 2010, Vol. 14 ›› Issue (45): 8526-8530.doi: 10.3969/j.issn.1673-8225.2010.45.039

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Autologous peripheral blood mononuclear cells transplantation in treatment of 30 cases of critical limb ischemia: 3-year safety follow-up

Wen Jin-chao, Huang Ping-ping   

  1. Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin  300020, China
  • Online:2010-11-05 Published:2010-11-05
  • Contact: Huang Ping-ping, Doctor, Chief physician, Doctoral supervisor, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin 300020, China huangpp66@yahoo.com.cn
  • About author:Wen Jin-chao★, Master, Associate chief physician, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin 300020, China wruting@126.com
  • Supported by:

    a grant of the Key Science and Technology Project of Tianjin City, No.08ZCKFSF03200*　

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Abstract:

BACKGROUND: Stem cell therapy for vascular diseases has been a hot research point. At present, no reports have addressed diagnostic criteria or long-term safety.
OBJECTIVE: To assess safety, efficacy and feasibility of the application of autologous transplantation of peripheral blood stem cells (PBSC) in the treatment of critical limb ischemia (CLI).
METHODS: A total of 60 patients with CLI (30 cases of diabetic foot, 22 cases of atherosclerosis obliterans and 8 cases of thromboangiitis obliterans) were enrolled and randomized to the transplant group and control group. In the transplant group, the patients received subcutaneous injection of recombinant human granulocyte colony-stimulating factor (G-CSF) (600 μg/d) for
5 days to mobilize stem/progenitor cells, and their peripheral blood mononuclear cells were collected and transplanted by multiple intramuscular injections into ischemic limbs. All patients were followed up after at least 3 months, but those in the transplant group were at least 3 years.
RESULTS AND CONCLUSION: The main manifestations, including lower limb pain and ulcers, were significantly improved in patients of the transplant group. The results of laser Doppler flowmetry showed that blood perfusion of lower limbs increased from (0.42±0.13) to (0.59±0.12) perfusion units (P < 0.001). Mean ankle-brachial pressure index was increased from (0.47±0.22) to (0.59±0.27) (P < 0.001). A total of 28 of 40 limb ulcers (70.0%) of transplanted patients were completely healed after cell transplantation, whereas only 26.8% of limb ulcers (11 of 41) were healed in the control patients (P=0.012). Angiographic scores were significantly improved in the transplant group compared with the control group (P = 0.002). One patient received a lower limb amputation in the transplanted patients. In control group, five control patients received a lower limb amputation (P = 0.005). No adverse effects specifically related to cell transplantation were observed in the transplant group at least 3 years after treatment. These results indicate that blood stem cell transplantation standard scheme for CLI is simple, safe and effective.

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