Autologous stem cell therapy in the treatment of limb ischaemia induced chronic tissue ulcers of diabetic foot patients
Autologous stem cell therapy in the treatment of limb ischaemia induced chronic tissue ulcers of diabetic foot patients
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DOI：
10.1111/j.1742-1241.2011.02886.x
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发表时间：
2012-04-01
影响因子：
2.6
通讯作者：
Tschoepe, D.
中科院分区：
文献类型：
--
作者：
Kirana, S.;Stratmann, B.;Tschoepe, D.
背景和目的：尽管手术血运重建有所改善，但解剖学因素或动脉粥样硬化等局限性限制了糖尿病重症肢体缺血患者血运重建的成功。已发表的研究表明，干细胞可以改善微循环。本研究旨在评价骨髓源性细胞制品移植在改善微循环和降低截肢率方面的安全性、可行性和有效性。方法：将骨髓单个核细胞（BMCs）与扩增的CD90+细胞（“组织修复细胞”，TRCs）进行比较，用于治疗糖尿病溃疡，以诱导血管重建。伴有严重肢体缺血且不能选择手术或介入血运重建的糖尿病足患者是合格的。治疗前后检测ABI、TcPO2、反应性充血、血管造影等指标。结果：本试验纳入的30例患者中，24例随机接受bmc或TRCs治疗。对照组（6例中有4例）的高退出率导致被排除在评估之外。共有22例患者进入治疗；TRC组1例、BMC组2例患者在随访期间伤口未愈合，各治疗组1例患者在研究结束前死亡；一组创面愈合后（BMC组），另一组创面未愈合（TRC组）。因此，18例患者在45周后伤口愈合。TRC组应用的细胞总数是TRC组的3.8倍，但TRC患者接受的CD90+细胞数量明显增加。微血管化改善在一些患者中检测到，但不是所有患者，两个治疗组的TcPO2与基线相比均有显著改善。结论：bmc和TRCs的移植是安全可行的。移植组微循环改善，创面完全愈合。
Background and aim: Despite improvements in surgical revascularisation, limitations like anatomical factors or atherosclerosis limit the success of revascularisation in diabetic patients with critical limb ischaemia. Stem cells were shown to improve microcirculation in published studies. The aim of this study was to evaluate safety, feasibility and efficacy of transplantation of bone marrow derived cellular products regarding improvement in microcirculation and lowering of amputation rate. Methods: Bone marrow mononuclear cells (BMCs) in comparison with expanded bone marrow cells enriched in CD90+ cells ('tissue repair cells', TRCs) were used in the treatment of diabetic ulcers to induce revascularisation. Diabetic foot patients with critical limb ischaemia without option for surgical or interventional revascularisation were eligible. Parameters examined were ABI, TcPO2, reactive hyperaemia and angiographic imaging before and after therapy. Results: Of 30 patients included in this trial, 24 were randomised to receive either BMCs or TRCs. The high number of drop- outs in the control group (4 of 6) led to exclusion from evaluation. A total of 22 patients entered treatment; one patient in the TRC group and two in the BMC group did not show wound healing during follow up, one patient in each treatment group died before reaching the end of the study; one after having achieved wound healing (BMC group), the other one without having achieved wound healing (TRC group). Thus, 18 patients showed wound healing after 45 weeks. The total number of applicated cells was 3.8 times lower in the TRC group, but TRC patients received significantly higher amounts of CD90+ cells. Improvement in microvascularisation was detected in some, but not all patients by angiography, TcPO2 improved significantly compared with baseline in both therapy groups. Conclusion: The transplantation of BMCs as well as TRCs proved to be safe and feasible. Improvements of microcirculation and complete wound healing were observed in the transplant groups.