Hwang Gyudeok, Jeong Hyunsuk, Yang Hae Kyung, Kim Hun-Sung, Hong Hanter, Kim Na Jin, Oh Il-Hoan, Yim Hyeon Woo
The Catholic University of Korea, Catholic Medical Center, Seoul, Korea.
Department of Preventive Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Int J Stem Cells. 2019 Jul 31;12(2):195-205. doi: 10.15283/ijsc18076.
This study was performed to investigate whether stem cell therapy enhances cell function by meta-analysis with proper consideration of variability of outcome measurements in controlled trial of type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) patients.
A systematic search was performed from inception to January 2018 in PubMed, EMBASE, and Cochrane databases. cell function was assessed by stimulated C-peptide, fasting C-peptide, normal glycosylated hemoglobin levels (HbA1C), and exogenous insulin dose patterns. The quality of the studies were assessed by both the Cochrane Collaboration's Risk of Bias (ROB) for Randomized controlled trials and the Risk of Bias in Non-randomized Studies of Interventions (ROBINS-I) for non-randomized controlled trials.
From the selected final 15 articles, total of 16 trials were analyzed. There were 6 T1DM trials (total 153 cases) and 10 T2DM trials (total 457 cases). In T2DM patients, the changes in stimulated C-peptide, HbA1c, and exogenous insulin dose versus baseline showed a favorable pattern with a significant heterogeneity in stem cell therapy. In T1DM, there was no significant difference between control group and stem cell therapy group in three indicators except for HbA1c. Most of the studies were rated as having high risk of bias in the quality assessment.
The stem cell therapy for DM patients is not effective in T1DM but seems to be effective in improving the cell function in T2DM. However the observed effect should be interpreted with caution due to the significant heterogeneity and high risk of bias within the studies. Further verification through a rigorously designed study is warranted.
本研究旨在通过荟萃分析，在充分考虑1型糖尿病（T1DM）和2型糖尿病（T2DM）患者对照试验中结果测量变异性的情况下，研究干细胞疗法是否能增强细胞功能。
从创刊至2018年1月，在PubMed、EMBASE和Cochrane数据库中进行了系统检索。通过刺激C肽、空腹C肽、正常糖化血红蛋白水平（HbA1C）和外源性胰岛素剂量模式评估细胞功能。研究质量通过Cochrane协作网的随机对照试验偏倚风险（ROB）和非随机干预研究偏倚风险（ROBINS-I）进行评估。
从最终选定的15篇文章中，共分析了16项试验。其中有6项T1DM试验（共153例）和10项T2DM试验（共457例）。在T2DM患者中，与基线相比，刺激C肽、HbA1c和外源性胰岛素剂量的变化显示出干细胞疗法具有良好的模式，但存在显著异质性。在T1DM中，除HbA1c外，对照组和干细胞治疗组在三项指标上无显著差异。在质量评估中，大多数研究被评为具有高偏倚风险。
干细胞疗法对DM患者在T1DM中无效，但似乎对改善T2DM中的细胞功能有效。然而，由于研究中存在显著的异质性和高偏倚风险，对观察到的效果应谨慎解释。有必要通过严格设计的研究进行进一步验证。
