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Autologous bone marrow stem cell transplantation in critical limb ischemia: a meta-analysis of randomized controlled trials.
MedLine Citation:
PMID:  23217403     Owner:  NLM     Status:  In-Data-Review    
BACKGROUND: Amputation-free survival (AFS) has been recommended as the gold standard for evaluating No-Option Critical Limb Ischemia (NO-CLI) therapy. Early-phase clinical trials suggest that autologous bone-marrow derived cells (BMCs) transplantation may have a positive effect on patients with NO-CLI, especially decreasing the incidence of amputation. However, the BMCs therapeutic efficacy remains controversial and whether BMCs therapy is suitable for all CLI patients is unclear.
METHODS: We conducted a meta-analysis using data from randomized controlled trials (RCTs) by comparing autologous BMCs therapy with controls in patients with critical limb ischemia, and the primary endpoint is the incidence of amputation. Pubmed, EBSCO and the Cochrane Central Register of Controlled Trials (to approximately July 25, 2012) were searched.
RESULTS: Seven RCTs with 373 patients were enrolled in the meta-analysis. Because serious disease was the main reason leading to amputation in one trial, six studies with 333 patients were finally included in the meta-analysis. Pooling the data of the final six studies, we found that BMCs therapy significantly decreased the incidence of amputation in patients with CLI (odds ratio (OR), 0.37; 95% confidence interval (CI), 0.22 to 0.62; P = 0.0002), and the efficacy had not significantly declined within 6 months after BMCs were transplanted; OR, 0.33; 95%CI, 0.16 to 0.70; P = 0.004 within 6 months and OR, 0.30; 95%CI, 0.11 to 0.79; P = 0.01 within 3 months. The rate of AFS after BMCs therapy was significantly increased in patients with Rutherford class 5 CLI (OR 3.28; 95%CI, 1.12 to 9.65; P = 0.03), while there was no significant improvement in patients with Rutherford class 4 (OR 0.35; 95%CI, 0.05 to 2.33; P = 0.28) compared with controls. The BMCs therapy also improved ulcer healing (OR, 5.83; 95%CI, 2.37 to 14.29; P = 0.0001).
CONCLUSIONS: Our analysis suggests that autologous BMCs therapy has a beneficial effect in decreasing the incidence of amputation and the efficacy does not decrease significantly within 6 months after BMCs transplantation. Patients with Rutherford class 5 are suitable for BMCs therapy, while the efficiency in patients with Rutherford 4 needs further evaluation.
Fu-Peng Liu; Jian-Jun Dong; Shu-Juan Sun; Wei-Yi Gao; Zhong-Wen Zhang; Xiao-Jun Zhou; Liu Yang; Jun-Yu Zhao; Jin-Ming Yao; Meng Liu; Lin Liao
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Chinese medical journal     Volume:  125     ISSN:  0366-6999     ISO Abbreviation:  Chin. Med. J.     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-12-10     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7513795     Medline TA:  Chin Med J (Engl)     Country:  China    
Other Details:
Languages:  eng     Pagination:  4296-300     Citation Subset:  IM    
Division of Endocrinology, Department of Medicine, Shandong Provincial Qianfoshan Hospital, Jinan, Shandong 250014, China.
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