title: Combination of autologous transplantation of G-CSF-mobilized peripheral blood mononuclear cells and Panax notoginseng saponins in the treatment of unreconstructable critical limb ischemia.
abstract: BACKGROUND
  The aim of this study is to explore the efficacy and safety of the combination of autologous transplantation of granulocyte colony-stimulating factor (G-CSF)-mobilized peripheral blood mononuclear cells (PBMNCs) and Panax notoginseng saponins (PNS) in the treatment of unreconstructable critical limb ischemia (CLI).
  
  
  METHODS
  We performed an open-label, parallel-group, single-center, randomized clinical trial in this study. A total of 52 patients were enrolled and randomly divided into 2 groups (the PBMNC + PNS group and the PBMNC group) in a 1:1 ratio. Evaluation variables, including changes in the ankle-brachial index (ABI) of ischemic limbs, ulcer area, severity of rest pain, transcutaneous oxygen pressure (T(C)PO2), and 6-min walk distance from baseline to week 8 and 16, as well as angiographic scores for new collateral vessel formation at week 16, were used to compare the benefits of these 2 treatment approaches.
  
  
  RESULTS
  After 16 weeks of treatment, improvement in ABI, T(C)PO2, and 6-min walk distance was significantly better in the PBMNC + PNS group. In addition, the combination of PBMNC transplantation and PNS administration yielded a greater reduction in ulcer area and severity of rest pain than did PBMNC transplantation alone. The proportion of patients experiencing any adverse event was similar between both treatment groups. Adverse events caused by PBMNC transplantation or PNS were generally mild and no serious adverse events occurred throughout the entire period of study.
  
  
  CONCLUSIONS
  A combination of PNS and PBMNC transplantation appears to be a safe and effective treatment for patients with unreconstructable CLI. This combination may have great potential advantages in comparison with PBMNC transplantation alone and might constitute a novel therapeutic option for unreconstructable CLI.
authors.affiliation: Department of Vascular Interventional Radiology, the Affiliated Hospital of Weifang Medical University, Weifang, Shandong Province, China.
authors.forename: Xiuchun
authors.initials: X
authors.lastname: Wang
authors.affiliation: Department of Rehabilitation and Health Care Services, Weifang People's Hospital, Weifang, Shandong Province, China.
authors.forename: Liping
authors.initials: L
authors.lastname: Jiang
authors.affiliation: Department of Vascular Interventional Radiology, the Affiliated Hospital of Weifang Medical University, Weifang, Shandong Province, China.
authors.forename: Xuemei
authors.initials: X
authors.lastname: Wang
authors.affiliation: Department of Vascular Interventional Radiology, the Affiliated Hospital of Weifang Medical University, Weifang, Shandong Province, China.
authors.forename: Fengling
authors.initials: F
authors.lastname: Yin
authors.affiliation: Department of Vascular Interventional Radiology, the Affiliated Hospital of Weifang Medical University, Weifang, Shandong Province, China. Electronic address: guixin_li2013@163.com.
authors.forename: Guixin
authors.initials: G
authors.lastname: Li
authors.affiliation: Department of Vascular Interventional Radiology, the Affiliated Hospital of Weifang Medical University, Weifang, Shandong Province, China.
authors.forename: Xueqiang
authors.initials: X
authors.lastname: Feng
authors.affiliation: Department of Vascular Interventional Radiology, the Affiliated Hospital of Weifang Medical University, Weifang, Shandong Province, China.
authors.forename: Kai
authors.initials: K
authors.lastname: Wang
authors.affiliation: Department of Vascular Interventional Radiology, the Affiliated Hospital of Weifang Medical University, Weifang, Shandong Province, China.
authors.forename: Shunji
authors.initials: S
authors.lastname: Sun
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015901:Angiography, Digital Subtraction; D055109:Ankle Brachial Index; D002681:China; D003131:Combined Modality Therapy; D016638:Critical Illness; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000302:isolation & purification / Q000627:therapeutic use*; D005080:Exercise Test; D017079:Exercise Tolerance; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000009:adverse effects / Q000627:therapeutic use*; D006439:Hemodynamics; D006801:Humans; D007511:Ischemia / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D053723:Panax notoginseng / Q000737:chemistry; D036102:Peripheral Blood Stem Cell Transplantation / Q000009:adverse effects; D008517:Phytotherapy; D010946:Plants, Medicinal; D012503:Saponins / Q000009:adverse effects / Q000302:isolation & purification / Q000627:therapeutic use*; D013997:Time Factors; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D014945:Wound Healing
chemical_list: D004365:Drugs, Chinese Herbal; D012503:Saponins; D016179:Granulocyte Colony-Stimulating Factor