Qu Jiayang, Liu Zicai, Li Lincai, Zou Zhengwei, He Zhengyi, Zhou Lin, Luo Yaolin, Zhang Minhong, Ye Junsong
The First Clinical Medicine College of Gannan Medical University, Ganzhou, China.
Subcenter for Stem Cell Clinical Translation, First Affiliated Hospital of Gannan Medical University, Ganzhou, China.
Front Pediatr. 2022 May 4;10:897398. doi: 10.3389/fped.2022.897398. eCollection 2022.
There is insufficient evidence regarding the efficacy and safety of stem cell therapy for autism spectrum disorders. We performed the first meta-analysis of stem cell therapy for autism spectrum disorders in children to provide evidence for clinical rehabilitation.
The data source includes PubMed/Medline, Web of Science, EMBASE, Cochrane Library and China Academic Journal, from inception to 24th JULY 2021. After sifting through the literature, the Cochrane tool was applied to assess the risk of bias. Finally, we extracted data from these studies and calculated pooled efficacy and safety.
5 studies that met the inclusion criteria were included in current analysis. Meta-analysis was performed using rehabilitation therapy as the reference standard. Data showed that the Childhood Autism Rating Scale score of stem cell group was striking lower than the control group (WMD: -5.96; 95%CI [-8.87, -3.06]; < 0.0001). The Clinical Global Impression score consolidated effect size RR = 1.01, 95%CI [0.87, 1.18], Z = 0.14 ( = 0.89), the effective rate for The Clinical Global Impression was 62% and 60% in the stem cell group and the control group, respectively. The occurrence events of adverse reactions in each group (RR = 1.55; 95%CI = 0.60 to 3.98; = 0.36), there was no significant difference in the incidence of adverse reactions between the stem cell group and the control group.
The results of this meta-analysis suggested that stem cell therapy for children with autism might be safe and effective. However, the evidence was compromised by the limitations in current study size, lacking standardized injection routes and doses of stem cells, as well as shortages in diagnostic tools and long period follow-up studies. Hence, it calls for more studies to systematically confirm the efficacy and safety of stem cell therapy for children with autism spectrum disorders.
关于干细胞疗法治疗自闭症谱系障碍的疗效和安全性,目前证据不足。我们首次对儿童自闭症谱系障碍的干细胞疗法进行荟萃分析,为临床康复提供依据。
数据来源包括PubMed/Medline、Web of Science、EMBASE、Cochrane图书馆和中国学术期刊,时间跨度从创刊至2021年7月24日。在筛选文献后,应用Cochrane工具评估偏倚风险。最后,我们从这些研究中提取数据并计算合并疗效和安全性。
本分析纳入了5项符合纳入标准的研究。以康复治疗作为参考标准进行荟萃分析。数据显示,干细胞组的儿童自闭症评定量表得分显著低于对照组(加权均数差:-5.96;95%置信区间[-8.87,-3.06];P<0.0001)。临床总体印象量表得分合并效应量RR = 1.01,95%置信区间[0.87,1.18],Z = 0.14(P = 0.89),干细胞组和对照组的临床总体印象有效率分别为62%和60%。每组不良反应的发生事件(RR = 1.55;95%置信区间 = 0.60至3.98;P = 0.36),干细胞组和对照组之间的不良反应发生率无显著差异。
这项荟萃分析的结果表明,干细胞疗法治疗自闭症儿童可能是安全有效的。然而,目前的研究规模有限、缺乏标准化的干细胞注射途径和剂量,以及诊断工具不足和长期随访研究的缺乏,这些因素削弱了证据的说服力。因此,需要更多的研究来系统地证实干细胞疗法治疗自闭症谱系障碍儿童的疗效和安全性。