PMID- 35752865 OWN - NLM STAT- MEDLINE DCOM- 20220628 LR - 20221104 IS - 1757-6512 (Electronic) IS - 1757-6512 (Linking) VI - 13 IP - 1 DP - 2022 Jun 25 TI - Safety, efficacy and biomarkers analysis of mesenchymal stromal cells therapy in ARDS: a systematic review and meta-analysis based on phase I and II RCTs. PG - 275 LID - 10.1186/s13287-022-02956-3 [doi] LID - 275 AB - BACKGROUND: 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. METHODS: 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. FINDINGS: 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. INTERPRETATION: 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. CI - (c) 2022. The Author(s). FAU - Wang, Jianbao AU - Wang J AD - Department of Respiratory and Critical Care Medicine, Fujian Respiratory Medical Center, The Second Affiliated Hospital of Fujian Medical University, Quanzhou City, Fujian Province, China. FAU - Luo, Fenbin AU - Luo F AD - Department of Respiratory and Critical Care Medicine, Fujian Respiratory Medical Center, The Second Affiliated Hospital of Fujian Medical University, Quanzhou City, Fujian Province, China. FAU - Suo, Ye AU - Suo Y AD - Department of Respiratory and Critical Care Medicine, Fujian Respiratory Medical Center, The Second Affiliated Hospital of Fujian Medical University, Quanzhou City, Fujian Province, China. FAU - Zheng, Yuxin AU - Zheng Y AD - Department of Respiratory and Critical Care Medicine, Fujian Respiratory Medical Center, The Second Affiliated Hospital of Fujian Medical University, Quanzhou City, Fujian Province, China. FAU - Chen, Kaikai AU - Chen K AD - Department of Respiratory and Critical Care Medicine, Fujian Respiratory Medical Center, The Second Affiliated Hospital of Fujian Medical University, Quanzhou City, Fujian Province, China. FAU - You, Deyuan AU - You D AD - Department of Respiratory and Critical Care Medicine, Fujian Respiratory Medical Center, The Second Affiliated Hospital of Fujian Medical University, Quanzhou City, Fujian Province, China. FAU - Liu, Yuqi AU - Liu Y AUID- ORCID: 0000-0003-0334-5349 AD - Department of Respiratory and Critical Care Medicine, Fujian Respiratory Medical Center, The Second Affiliated Hospital of Fujian Medical University, Quanzhou City, Fujian Province, China. fjydfseyicu@163.com. LA - eng GR - P30 CA086862/CA/NCI NIH HHS/United States PT - Journal Article PT - Meta-Analysis PT - Research Support, Non-U.S. Gov't PT - Review PT - Systematic Review DEP - 20220625 PL - England TA - Stem Cell Res Ther JT - Stem cell research & therapy JID - 101527581 SB - IM MH - Humans MH - *Mesenchymal Stem Cells MH - *Respiratory Distress Syndrome/therapy PMC - PMC9233855 OTO - NOTNLM OT - Acute respiratory distress syndrome OT - Adverse events OT - Biomarkers OT - Mesenchymal stromal cells OT - Meta-analysis OT - Mortality OT - Serious adverse events OT - Stem cell OT - Systematic review COIS- The authors have disclosed that they do not have any potential conflicts of interest. EDAT- 2022/06/26 06:00 MHDA- 2022/06/29 06:00 PMCR- 2022/06/25 CRDT- 2022/06/25 23:34 PHST- 2022/04/05 00:00 [received] PHST- 2022/06/08 00:00 [accepted] PHST- 2022/06/25 23:34 [entrez] PHST- 2022/06/26 06:00 [pubmed] PHST- 2022/06/29 06:00 [medline] PHST- 2022/06/25 00:00 [pmc-release] AID - 10.1186/s13287-022-02956-3 [pii] AID - 2956 [pii] AID - 10.1186/s13287-022-02956-3 [doi] PST - epublish SO - Stem Cell Res Ther. 2022 Jun 25;13(1):275. doi: 10.1186/s13287-022-02956-3.