Autologous bone marrow cell transplantation for patients with diabetic foot: a systematic review_Chinese Journal of Evidence-Based Medicine

Authors：

GAO Haihui ^1,2 , LV Xiafei ³ , LI Sheyu ¹ , TIAN Haoming ¹ ,  RAN Xingwu ¹

1. Department of Endocrinology and Metabolism, West China Hospital of Sichuan University, Chengdu, 610041, P.R.China;
2. West China School of Medicine, Sichuan University, Chengdu, 610041, P.R.China;
3. Department of Radiology, West China Hospital of Sichuan University, Chengdu, 610041, P.R.China;

Corresponding?author：

RAN Xingwu, Email: ranxingwu@163.com

Keywords：

Diabetic foot; Autologous bone marrow mononuclear cell transplantation; Randomized controlled trial; Meta-analysis; Systematic review

DOI：

10.7507/1672-2531.201708010

Video：

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ObjectivesTo systematically review the efficacy and safety of autologous bone marrow cells therapy for patients with diabetic foot. GRADE system was used to evaluate the evidence quality of outcomes.MethodsWe searched databases including PubMed, EMbase, The Cochrane Library, CBM, WanFang Data and CNKI for randomized controlled trials (RCTs) about bone marrow cell transplantation in patients with diabetic foot from inception to February 28^th 2017. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was performed using RevMan 5.3 software. The evidence quality was evaluated by using GRADE profiler 3.6 software.ResultsFour RCTs were included. Meta-analysis showed that the bone marrow cell transplantation could decrease the rate of amputation (RR=0.08, 95%CI 0.00 to 1.32, P=0.08) and rest pain score (MD=–1.89, 95%CI –2.24 to –1.55, P<0.000 01), increase the rate of ameliorate ulcer healing (RR=2.01, 95%CI 1.45 to 2.79,P<0.000 1) and the quantity of new collateral vessels (MD=1.33, 95%CI 0.60 to 2.05,P<0.000 3). Besides, bone marrow cell transplantation could improve ankle-brachial index (MD=0.16, 95%CI 0.10 to 0.22,P<0.000 01) and transcutaneous arterial oxygen tension (MD=18.81, 95%CI 16.06 to 21.57,P<0.000 01). No adverse event was reported for all included studies. The qualities of evidence for all outcomes were rated as "low" to "very low".ConclusionBased on the current evidence, autologous bone marrow cells transplantation therapy has a certain effect and it is safe for patients with diabetic foot. However, due to the limited quantity and quality of included studies, the above conclusions are still needed more multicenter clinical trials with large sample size to confirm.

Citation： GAO Haihui, LV Xiafei, LI Sheyu, TIAN Haoming, RAN Xingwu. Autologous bone marrow cell transplantation for patients with diabetic foot: a systematic review. Chinese Journal of Evidence-Based Medicine, 2018, 18(2): 185-191. doi: 10.7507/1672-2531.201708010 Copy

1.	李舍予, 李蕓, 周方勵, 等. 四川大學華西醫院內分泌代謝科 2011～2012 年住院患者疾病構成與費用調查. 中國循證醫學雜志, 2014, 14(1): 25-29.
2.	李舍予, 李蕓, 周方勵, 等. 四川大學華西醫院內分泌代謝科 2011 年糖尿病住院患者費用情況調查. 中國循證醫學雜志, 2013, 13(10): 1180-1184.
3.	周海龍, 楊曉妍, 潘曉平, 等. 中國人群糖尿病疾病負擔的系統評價. 中國循證醫學雜志, 2014(12): 1442-1449.
4.	侯清濤, 李蕓, 李舍予, 等. 全球糖尿病疾病負擔現狀. 中國糖尿病雜志, 2016, 24(1): 92-96.
5.	管珩, 劉志民, 李光偉, 等. 50 歲以上糖尿病人群周圍動脈閉塞性疾病相關因素分析. 中華醫學雜志, 2007, 87(1): 23-27.
6.	侯宇穎, 張志剛, 張珺, 等. 九種常用敷料治療糖尿病足效果的網狀 Meta 分析. 中國循證醫學雜志, 2016, 16(11): 1291-1297.
7.	李永恒, 何利平, 冉興無, 等. 華西醫院住院糖尿病足的流行率及臨床療效. 西部醫學, 2011, 23(7): 1228-1232.
8.	中國醫療保健國際交流促進會糖尿病足病分會. 中國糖尿病足診治指南. 中華醫學雜志, 2017, 97(4): 251-258.
9.	王芳, 高偉, 冉興無. 自體骨髓干細胞移植治療糖尿病周圍神經病變的系統評價. 中國循證醫學雜志, 2013, 13(9): 1090-1095.
10.	劉超, 吳海琴, 嚴璞, 等. 骨髓間充質干細胞移植治療缺血性腦卒中療效和安全性的 Meta 分析. 中國循證醫學雜志, 2015(6): 659-663.
11.	楊柳, 唐其柱, 郭毅. 骨髓干細胞移植治療擴張性心肌病療效及安全性的系統評價. 中國循證醫學雜志, 2015(2): 194-200.
12.	谷涌泉, 郭連瑞, 張建, 等. 自體骨髓干細胞移植治療嚴重下肢缺血 1 例. 中國實用外科雜志, 2003, 19(11): 687-688.
13.	Benoit E, O'Donnell TF Jr, Iafrati MD, et al. The role of amputation as an outcome measure in cellular therapy for critical limb ischemia: implications for clinical trial design. J Transl Med, 2011, 9(1): 165.
14.	Dubsky M, Jirkovská A, Bem R, et al. Comparison of the effect of stem cell therapy and percutaneous transluminal angioplasty on diabetic foot disease in patients with critical limb ischemia. Cytotherapy, 2014, 16(12): 1733-1738.
15.	Tateishi-Yuyama E, Matsubara H, Murohara T, et al. Therapeutic angiogenesis for patients with limb ischaemia by autologous transplantation of bone-marrow cells: a pilot study and a randomised controlled trial. Lancet, 2002, 360(9331): 427-435.
16.	Bartsch T, Brehm M, Zeus T, et al. Transplantation of autologous mononuclear bone marrow stem cells in patients with peripheral arterial disease (The TAM-PAD Study). Clin Res Cardiol, 2007, 96(12): 891-899.
17.	Sprengers RW, Lips DJ, Moll FL, et al. Progenitor cell therapy in patients with critical limb ischemia without surgical options. Ann Surg, 2008, 247(3): 411-420.
18.	Matoba S, Tatsumi T, Murohara T, et al. Long-term clinical outcome after intramuscular implantation of bone marrow mononuclear cells (therapeutic angiogenesis by cell transplantation [TACT] trial) in patients with chronic limb ischemia. Am Heart J, 2008, 156(5): 1010-1018.
19.	Kirana S, Stratmann B, Prante C, et al. Autologous stem cell therapy in the treatment of limb ischaemia induced chronic tissue ulcers of diabetic foot patients. Int J Clin Pract, 2012, 66(4): 384-393.
20.	Dubsky M, Jirkovska A, Bem R, et al. Both autologous bone marrow mononuclear cell and peripheral blood progenitor cell therapies similarly improve ischaemia in patients with diabetic foot in comparison with control treatment. Diabetes Metab Res Rev, 2013, 29(5): 369-376.
21.	Iwase T, Nagaya N, Fujii T, et al. Comparison of angiogenic potency between mesenchymal stem cells and mononuclear cells in a rat model of hindlimb ischemia. Cardiovasc Res, 2005, 66(3): 543-551.
22.	Ishikane S, Ohnishi S, Yamahara K, et al. Allogeneic injection of fetal membrane-derived mesenchymal stem cells induces therapeutic angiogenesis in a rat model of hind limb ischemia. Stem Cells, 2008, 26(10): 2625-2633.
23.	Dash NR, Dash SN, Routray P, et al. Targeting nonhealing ulcers of lower extremity in human through autologous bone marrow-derived mesenchymal stem cells. Rejuvenation Res, 2009, 12(5): 359-366.
24.	The Cochrane Collaboration. Cochrane handbook for systematic reviews of interventions. Available at: http://www.cochrane.org/.
25.	Lu D, Chen B, Liang Z, et al. 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. Diabetes Res Clin Pract, 2011; 92(1): 26-36.
26.	張忠, 劉文申, 趙秀蘭. 自體骨髓干細胞移植治療糖尿病足潰瘍. 實用臨床醫學, 2007, 8(8): 58-60.
27.	陳兵, 陸德賓, 梁自文, 等. 自體骨髓間充質干細胞體外擴增后移植治療糖尿病足. 中國組織工程研究與臨床康復, 2009, 13(32): 6227-6230.
28.	甘宇, 李鐵男, 于黎麗, 等. 自體骨髓干細胞移植配合中藥治療糖尿病足潰瘍的療效及其與血清 VEGF 水平關系的研究. 中國中西醫結合皮膚性病學雜志, 2010, 9(4): 206-209.
29.	Koch TG, Heerkens T, Thomsen PD, et al. Isolation of mesenchymal stem cells from equine umbilical cord blood. BMC Biotechnol, 2007, 7(1): 1-9.
30.	王晶, 周敏, 孟荔, 等. 兩種分離人骨髓單個核細胞方法的比較. 實用醫學雜志, 2009, 25(5): 725-726.
31.	郝洪波, 任思坡, 謝曉東. 密度梯度離心法分離骨髓單個核細胞方法的優化. 吉林醫學, 2012, 33(35): 7619-7620.
32.	遲作華, 張洹, 陸琰. 人骨髓間充質干細胞分離方法的比較. 中國組織工程研究, 2006, 10(1): 20-22.
33.	蔡金宏, 林春博, 楊淵. 間充質干細胞分離方法的研究與進展. 中國組織工程研究, 2014, 18(45): 7375-7380.
34.	邢文, 龐愛明, 姚劍峰, 等. 直接鋪種結合改良組織塊培養法可有效分離人骨髓中的間充質干細胞. 中國實驗血液學雜志, 2013, 21(2): 451-454.

1. 李舍予, 李蕓, 周方勵, 等. 四川大學華西醫院內分泌代謝科 2011～2012 年住院患者疾病構成與費用調查. 中國循證醫學雜志, 2014, 14(1): 25-29.
2. 李舍予, 李蕓, 周方勵, 等. 四川大學華西醫院內分泌代謝科 2011 年糖尿病住院患者費用情況調查. 中國循證醫學雜志, 2013, 13(10): 1180-1184.
3. 周海龍, 楊曉妍, 潘曉平, 等. 中國人群糖尿病疾病負擔的系統評價. 中國循證醫學雜志, 2014(12): 1442-1449.
4. 侯清濤, 李蕓, 李舍予, 等. 全球糖尿病疾病負擔現狀. 中國糖尿病雜志, 2016, 24(1): 92-96.
5. 管珩, 劉志民, 李光偉, 等. 50 歲以上糖尿病人群周圍動脈閉塞性疾病相關因素分析. 中華醫學雜志, 2007, 87(1): 23-27.
6. 侯宇穎, 張志剛, 張珺, 等. 九種常用敷料治療糖尿病足效果的網狀 Meta 分析. 中國循證醫學雜志, 2016, 16(11): 1291-1297.
7. 李永恒, 何利平, 冉興無, 等. 華西醫院住院糖尿病足的流行率及臨床療效. 西部醫學, 2011, 23(7): 1228-1232.
8. 中國醫療保健國際交流促進會糖尿病足病分會. 中國糖尿病足診治指南. 中華醫學雜志, 2017, 97(4): 251-258.
9. 王芳, 高偉, 冉興無. 自體骨髓干細胞移植治療糖尿病周圍神經病變的系統評價. 中國循證醫學雜志, 2013, 13(9): 1090-1095.
10. 劉超, 吳海琴, 嚴璞, 等. 骨髓間充質干細胞移植治療缺血性腦卒中療效和安全性的 Meta 分析. 中國循證醫學雜志, 2015(6): 659-663.
11. 楊柳, 唐其柱, 郭毅. 骨髓干細胞移植治療擴張性心肌病療效及安全性的系統評價. 中國循證醫學雜志, 2015(2): 194-200.
12. 谷涌泉, 郭連瑞, 張建, 等. 自體骨髓干細胞移植治療嚴重下肢缺血 1 例. 中國實用外科雜志, 2003, 19(11): 687-688.
13. Benoit E, O'Donnell TF Jr, Iafrati MD, et al. The role of amputation as an outcome measure in cellular therapy for critical limb ischemia: implications for clinical trial design. J Transl Med, 2011, 9(1): 165.
14. Dubsky M, Jirkovská A, Bem R, et al. Comparison of the effect of stem cell therapy and percutaneous transluminal angioplasty on diabetic foot disease in patients with critical limb ischemia. Cytotherapy, 2014, 16(12): 1733-1738.
15. Tateishi-Yuyama E, Matsubara H, Murohara T, et al. Therapeutic angiogenesis for patients with limb ischaemia by autologous transplantation of bone-marrow cells: a pilot study and a randomised controlled trial. Lancet, 2002, 360(9331): 427-435.
16. Bartsch T, Brehm M, Zeus T, et al. Transplantation of autologous mononuclear bone marrow stem cells in patients with peripheral arterial disease (The TAM-PAD Study). Clin Res Cardiol, 2007, 96(12): 891-899.
17. Sprengers RW, Lips DJ, Moll FL, et al. Progenitor cell therapy in patients with critical limb ischemia without surgical options. Ann Surg, 2008, 247(3): 411-420.
18. Matoba S, Tatsumi T, Murohara T, et al. Long-term clinical outcome after intramuscular implantation of bone marrow mononuclear cells (therapeutic angiogenesis by cell transplantation [TACT] trial) in patients with chronic limb ischemia. Am Heart J, 2008, 156(5): 1010-1018.
19. Kirana S, Stratmann B, Prante C, et al. Autologous stem cell therapy in the treatment of limb ischaemia induced chronic tissue ulcers of diabetic foot patients. Int J Clin Pract, 2012, 66(4): 384-393.
20. Dubsky M, Jirkovska A, Bem R, et al. Both autologous bone marrow mononuclear cell and peripheral blood progenitor cell therapies similarly improve ischaemia in patients with diabetic foot in comparison with control treatment. Diabetes Metab Res Rev, 2013, 29(5): 369-376.
21. Iwase T, Nagaya N, Fujii T, et al. Comparison of angiogenic potency between mesenchymal stem cells and mononuclear cells in a rat model of hindlimb ischemia. Cardiovasc Res, 2005, 66(3): 543-551.
22. Ishikane S, Ohnishi S, Yamahara K, et al. Allogeneic injection of fetal membrane-derived mesenchymal stem cells induces therapeutic angiogenesis in a rat model of hind limb ischemia. Stem Cells, 2008, 26(10): 2625-2633.
23. Dash NR, Dash SN, Routray P, et al. Targeting nonhealing ulcers of lower extremity in human through autologous bone marrow-derived mesenchymal stem cells. Rejuvenation Res, 2009, 12(5): 359-366.
24. The Cochrane Collaboration. Cochrane handbook for systematic reviews of interventions. Available at: http://www.cochrane.org/.
25. Lu D, Chen B, Liang Z, et al. 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. Diabetes Res Clin Pract, 2011; 92(1): 26-36.
26. 張忠, 劉文申, 趙秀蘭. 自體骨髓干細胞移植治療糖尿病足潰瘍. 實用臨床醫學, 2007, 8(8): 58-60.
27. 陳兵, 陸德賓, 梁自文, 等. 自體骨髓間充質干細胞體外擴增后移植治療糖尿病足. 中國組織工程研究與臨床康復, 2009, 13(32): 6227-6230.
28. 甘宇, 李鐵男, 于黎麗, 等. 自體骨髓干細胞移植配合中藥治療糖尿病足潰瘍的療效及其與血清 VEGF 水平關系的研究. 中國中西醫結合皮膚性病學雜志, 2010, 9(4): 206-209.
29. Koch TG, Heerkens T, Thomsen PD, et al. Isolation of mesenchymal stem cells from equine umbilical cord blood. BMC Biotechnol, 2007, 7(1): 1-9.
30. 王晶, 周敏, 孟荔, 等. 兩種分離人骨髓單個核細胞方法的比較. 實用醫學雜志, 2009, 25(5): 725-726.
31. 郝洪波, 任思坡, 謝曉東. 密度梯度離心法分離骨髓單個核細胞方法的優化. 吉林醫學, 2012, 33(35): 7619-7620.
32. 遲作華, 張洹, 陸琰. 人骨髓間充質干細胞分離方法的比較. 中國組織工程研究, 2006, 10(1): 20-22.
33. 蔡金宏, 林春博, 楊淵. 間充質干細胞分離方法的研究與進展. 中國組織工程研究, 2014, 18(45): 7375-7380.
34. 邢文, 龐愛明, 姚劍峰, 等. 直接鋪種結合改良組織塊培養法可有效分離人骨髓中的間充質干細胞. 中國實驗血液學雜志, 2013, 21(2): 451-454.

Chinese Journal of Evidence-Based Medicine

Autologous bone marrow cell transplantation for patients with diabetic foot: a systematic review

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