Department of Respiratory and Critical Care Medicine, Fujian Respiratory Medical Center, The Second Affiliated Hospital of Fujian Medical University, Quanzhou City, Fujian Province, China.
Stem Cell Res Ther. 2022 Jun 25;13(1):275. doi: 10.1186/s13287-022-02956-3.
Mesenchymal stromal cells (MSCs) therapy for acute respiratory distress syndrome (ARDS) is an emerging treatment, but most of the current trials of MSCs stay in the animal experimental stage, and the safety and efficacy of MSCs in clinical application are not clear. We aimed to analyze the safety, efficacy and biomarkers of mesenchymal stromal cells in the treatment of ARDS.
For this systematic review and meta-analysis, we searched PubMed, Embase, Cochrane Central Register of Controlled Trials, Web of science, CNKI, VIP and Wan Fang data, studies published between database inception and Mar 17, 2022. All randomized controlled trials (RCT) of stem cell interventions for ARDS were included, without language or date restrictions. We did separate meta-analyses for mortality, subjects with adverse events (AEs) and subjects with serious adverse events (SAEs). Since the trials data are dichotomous outcomes, the odds ratio (OR) is adopted for meta-analysis. The quality of the evidence was assessed with the Cochrane risk of bias tool.
In total, 5 trials involving 171 patients with ARDS were included in this meta-analysis. A total of 99 individuals were randomly assigned to receive MSCs treatment, and 72 were randomly assigned to receive placebo treatment. Treatment with MSCs appeared to increase the occurrence of adverse events, but this result was not statistically significant (OR, 1.58; 95%CI, 0.64-3.91; P = 0.32). The occurrence of serious adverse events was lower in the MSCs group than in the placebo group (OR, 0.57; 95%CI, 0.14-2.32; P = 0.43); there seems to be no significant difference between the two groups in terms of 28 days mortality (OR, 0.93; 95%CI, 0.45-1.89); oxygenation index and biomarkers showed a tendency to improve in treatment, but there was a lack of more statistically significant clinical evidence to support them.
Based on the current clinical trials, MSCs intervention has some safety for ARDS patients, but its effectiveness and predictive value of airspace biomarkers need to be determined by more large-scale, standard randomized controlled trials.
间充质基质细胞（MSC）治疗急性呼吸窘迫综合征（ARDS）是一种新兴的治疗方法，但目前大多数 MSC 的临床试验仍处于动物实验阶段，MSC 在临床应用中的安全性和疗效尚不清楚。我们旨在分析间充质基质细胞治疗 ARDS 的安全性、疗效和生物标志物。
本系统评价和荟萃分析检索了 PubMed、Embase、Cochrane 对照试验中心注册库、Web of Science、中国知网、维普和万方数据库，检索时间为数据库建立至 2022 年 3 月 17 日。纳入了所有用于 ARDS 的干细胞干预的随机对照试验（RCT），无语言或日期限制。我们分别对死亡率、不良事件（AE）和严重不良事件（SAE）患者进行了荟萃分析。由于试验数据为二项分类结局，采用比值比（OR）进行荟萃分析。采用 Cochrane 偏倚风险工具评估证据质量。
本荟萃分析共纳入了 5 项涉及 171 例 ARDS 患者的试验。共有 99 人被随机分配接受 MSC 治疗，72 人被随机分配接受安慰剂治疗。MSC 治疗似乎增加了不良事件的发生，但这一结果无统计学意义（OR，1.58；95%CI，0.64-3.91；P=0.32）。MSC 组严重不良事件的发生率低于安慰剂组（OR，0.57；95%CI，0.14-2.32；P=0.43）；28 天死亡率两组间似乎无显著差异（OR，0.93；95%CI，0.45-1.89）；氧合指数和生物标志物显示治疗有改善趋势，但缺乏更具统计学意义的临床证据支持。
基于目前的临床试验，MSC 干预对 ARDS 患者具有一定的安全性，但需要更多大规模、标准的随机对照试验来确定其疗效和肺泡生物标志物的预测价值。
