Endocrinology and Metabolism Research Institute, Tehran University of Medical Science, Tehran, Iran.
Tehran University of Medical Science, Tehran, Iran.
Syst Rev. 2018 Jan 26;7(1):23. doi: 10.1186/s13643-017-0662-9.
Insulin standard treatment of T1DM cannot cure the patients as different chronic complications occurred subsequently. Investigations on a curative treatment in T1DM propose cell replacement or maintenance instead of exogenous insulin therapy, but different dimensions of this novel treatment are not clarified.
We will include all clinical trials which have evaluated the efficacy MSC or HSC transplantation in T1DM treatment; electronically search bibliographic databases, country registration data banks, and gray literatures; and hand-search two key journals, two experts' article, and references of the included articles with no language restriction. Primary outcome is the extent of reduction in insulin requirement and secondary outcomes are safety of MSC and HSC therapy, effect of this therapy on diabetic parameters, effect of the rout of transplantation and origin of the MSC or HSC on efficacy of treatment, studies heterogeneity and potential reasons of it. Heterogeneity and its severity will be calculated with Q Cochrane test, P value, and I index. STATA software version 12 will be used for meta-analysis. PROSPERO Registration number: CRD42016047176.
We will publish the systematic review in a peer review journal; as it presents an analysis of published literature, the study does not require ethical approval.
This systematic review and meta-analysis will investigate the efficacy of MSC and HSC transplantation in T1DM treatment with no language restriction. Also we will evaluate gray literatures after hand searching. This protocol is prepared according to Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P). Two reviewers will evaluate screened full texts, extract data, and asses risk of bias of eligible primary studies independently. As there is the possibility that we miss some unpublished primary studies due to negative results, we will use funnel plot to detect this and correct it with fill and trim method.
1 型糖尿病患者接受胰岛素标准治疗后，仍会相继出现各种慢性并发症，无法痊愈。针对 1 型糖尿病的治疗方法，有研究提出细胞替代或维持治疗，而非外源性胰岛素治疗，但这种新型治疗方法的不同维度尚不清楚。
我们将纳入所有评估间充质干细胞或造血干细胞移植治疗 1 型糖尿病疗效的临床试验；通过电子检索文献数据库、国家注册数据库和灰色文献；并手工检索两份关键期刊、两位专家的文章以及纳入文章的参考文献，不限制语言。主要结局是胰岛素需求减少的程度，次要结局是间充质干细胞和造血干细胞治疗的安全性、该治疗对糖尿病参数的影响、移植途径和间充质干细胞或造血干细胞来源对治疗效果的影响、研究的异质性及其潜在原因。采用 Q Cochrane 检验、P 值和 I 指数计算异质性及其严重程度。使用 STATA 软件版本 12 进行荟萃分析。PROSPERO 注册号：CRD42016047176。
我们将在同行评议期刊上发表系统评价；由于该研究分析了已发表的文献，因此不需要伦理批准。
本系统评价和荟萃分析将对间充质干细胞和造血干细胞移植治疗 1 型糖尿病的疗效进行研究，不限制语言。我们还将在手检后评估灰色文献。本方案按照系统评价和荟萃分析报告的首选条目（PRISMA-P）制定。两位评审员将独立评估筛选出的全文、提取数据，并评估合格的原始研究的偏倚风险。由于我们有可能因结果为阴性而遗漏一些未发表的原始研究，我们将使用漏斗图来检测并使用填充和修剪方法进行校正。
