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
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
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DOI：
10.1016/j.diabres.2010.12.010
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发表时间：
2011-04-01
影响因子：
5.1
通讯作者：
Chen, Sihao
中科院分区：
文献类型：
--
作者：
Lu, Debin;Chen, Bing;Chen, Sihao
目的：为筛选治疗糖尿病严重肢体缺血（CLI）和足部溃疡的较好细胞，进行初步试验。方法：41例2型糖尿病合并双侧CLI和足部溃疡的患者，在常规治疗的基础上，分别肌肉注射骨髓间充质干细胞（BMMSCs）、骨髓单个核细胞（BMMNCs）或生理盐水（NS）。BMMSC组在注射后6周溃疡愈合率显著高于BMMNC组（P = 0.022），比BMMNC组提前4周达到100%。随访24周后，在无痛步行时间（P = 0.040）、踝臂指数（ABI）（P = 0.017）、经皮氧分压（TcO（2））（P = 0.001）和磁共振血管造影（MRA）分析（P = 0.018）方面，BMMSCs移植诱导的肢体灌注改善比BMMNCs更显著。两组之间在疼痛缓解和截肢方面没有显著差异，也没有与两种细胞注射相关的严重不良事件。结论：BMMSCs治疗可能比BMMNCs耐受性更好，更有效，可增加下肢灌注，促进糖尿病患者CLI足部溃疡愈合。(C)2010爱思唯尔爱尔兰有限公司版权所有。
Aims: 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. (C) 2010 Elsevier Ireland Ltd. All rights reserved.