RESUMEN
BACKGROUND AND OBJECTIVES: This study was performed to investigate whether stem cell therapy enhances ß 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. METHODS: A systematic search was performed from inception to January 2018 in PubMed, EMBASE, and Cochrane databases. ß 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. RESULTS: 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. CONCLUSIONS: The stem cell therapy for DM patients is not effective in T1DM but seems to be effective in improving the ß 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.
RESUMEN
BACKGROUND AND OBJECTIVES: Mesenchymal stem cells (MSC) have emerged as breakthrough treatments for myocardial infarction. However, the efficacy of MSC remains unclear. The aim of the study was to evaluate treatment effect of MSC in terms of mechanical, regenerative, and clinical outcomes for patients with myocardial infarction (MI) using meta-analysis. METHODS: A systematic search and critical review of MEDLINE, EMBASE, and Cochrane database literature published from inception through December 2017 was performed. The inclusion criteria were randomized controlled trials, studies on patients with myocardial infarction, and studies compared with placebo as a control group. RESULTS: A total of 950 patients from 14 randomized placebo controlled trials were included in the final meta-analysis. MSC treatment showed benefits for mechanical, regenerative, and clinical outcomes. In terms of mechanical outcomes, the LVEF of the MSC treatment group increased by 3.84% (95% CI: 2.32~5.35, I²=43) and the effect was maintained for up to 24 months. Regenerative outcomes were measured by scar mass and WMSI. Scar mass was reduced by -1.13 (95% CI: -1.80 to -0.46, I²=71) and WMSI was reduced by -0.05 (95% CI: -0.07 to -0.03, I²=45) at 6 months after MSC treatment. Mortality rate and incidence of re-hospitalization for HF in MSC group patients trended toward reduced incidence compared to the control group, although this was not statistically significant because of the low event rate. CONCLUSIONS: The findings of this meta-analysis indicate that MSCs can be beneficial in improving heart function in the treatment of MI. However, the efficacy of MSCs must be further explored through large randomized controlled trials based on rigorous research design.
