title: Comparison of bone marrow mesenchymal stem cells with bone marrow-derived mononuclear cells for treatment of diabetic critical limb ischemia and foot ulcer: a double-blind, randomized, controlled trial.
abstract: OBJECTIVE
  To identify better cells for the treatment of diabetic critical limb ischemia (CLI) and foot ulcer in a pilot trial.
  
  
  METHODS
  Under ordinary treatment, the limbs of 41 type 2 diabetic patients with bilateral CLI and foot ulcer were injected intramuscularly with bone marrow mesenchymal stem cells (BMMSCs), bone marrow-derived mononuclear cells (BMMNCs), or normal saline (NS).
  
  
  RESULTS
  The ulcer healing rate of the BMMSC group was significantly higher than that of BMMNCs at 6 weeks after injection (P=0.022), and reached 100% 4 weeks earlier than BMMNC group. After 24 weeks of follow-up, the improvements in limb perfusion induced by the BMMSCs transplantation were more significant than those by BMMNCs in terms of painless walking time (P=0.040), ankle-brachial index (ABI) (P=0.017), transcutaneous oxygen pressure (TcO(2)) (P=0.001), and magnetic resonance angiography (MRA) analysis (P=0.018). There was no significant difference between the groups in terms of pain relief and amputation and there was no serious adverse events related to both cell injections.
  
  
  CONCLUSIONS
  BMMSCs therapy may be better tolerated and more effective than BMMNCs for increasing lower limb perfusion and promoting foot ulcer healing in diabetic patients with CLI.
authors.affiliation: Department of Endocrinology and Metabolism, Southwest Hospital, Third Military Medical University, Chongqing 400038, China.
authors.forename: Debin
authors.initials: D
authors.lastname: Lu
authors.forename: Bing
authors.initials: B
authors.lastname: Chen
authors.forename: Ziwen
authors.initials: Z
authors.lastname: Liang
authors.forename: Wuquan
authors.initials: W
authors.lastname: Deng
authors.forename: Youzhao
authors.initials: Y
authors.lastname: Jiang
authors.forename: Shufa
authors.initials: S
authors.lastname: Li
authors.forename: Jing
authors.initials: J
authors.lastname: Xu
authors.forename: Qinan
authors.initials: Q
authors.lastname: Wu
authors.forename: Zhonghui
authors.initials: Z
authors.lastname: Zhang
authors.forename: Bing
authors.initials: B
authors.lastname: Xie
authors.forename: Sihao
authors.initials: S
authors.lastname: Chen
mesh_terms: D000328:Adult; D000368:Aged; D048909:Diabetes Complications; D017719:Diabetic Foot / Q000150:complications / Q000628:therapy*; D004311:Double-Blind Method; D005260:Female; D016523:Foot Ulcer / Q000628:therapy*; D006801:Humans; D007511:Ischemia / Q000628:therapy*; D007963:Leukocytes, Mononuclear / Q000637:transplantation*; D008297:Male; D045164:Mesenchymal Stem Cell Transplantation; D008875:Middle Aged