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This meta-analysis aimed to comprehensively evaluate the efficacy and safety of stem cell-based therapies, including mesenchymal stem\/stromal cells (MSCs) and their derived extracellular vesicles (EVs), in the treatment of ARDS.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A comprehensive literature search of the Cochrane Library, PubMed, and Web of Science databases and the US National Institutes of Health Trials Registry (ClinicalTrials.gov) was conducted to identify eligible studies assessing the efficacy and safety of stem cell-based therapies in ARDS. The primary outcomes included all-cause mortality within or over one month, adverse events (AEs), and serious adverse events (SAEs). To explore possible bias, subgroup analysis was performed based on the design of study (randomized controlled trial vs. nonrandomized interventional trial), etiology of ARDS, type of stem cell-based therapy, and times of infusion. Relative risk (RR) and mean difference (MD) were calculated to evaluate efficacy and safety. This study was registered with PROSPERO (CRD42024593740).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      A total of 48 studies involving 1,773 patients were eligible, of which 31 studies were included in the meta-analysis. The results revealed a significant reduction in all-cause mortality among patients receiving MSCs or their derived EVs and secretomes compared to those receiving routine therapy (RR\u2009=\u20090.74, 95% CI\u2009=\u20090.63\u20130.87,\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.0003,\n                      <jats:italic>I\u00b2<\/jats:italic>\n                      =5%). This effect was only seen in all-cause mortality within one month (RR\u2009=\u20090.74, 95% CI\u2009=\u20090.62\u20130.89,\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.002,\n                      <jats:italic>I\u00b2<\/jats:italic>\n                      =0%); furthermore, high dose MSCs (over 1\u2009\u00d7\u200910\n                      <jats:sup>6<\/jats:sup>\n                      cells\/kg or 7\u2009\u00d7\u200910\n                      <jats:sup>7<\/jats:sup>\n                      cells per infusion) was associated with reduction of all-cause mortality in ARDS (RR\u2009=\u20090.70, 95% CI\u2009=\u20090.55\u20130.89). There were no significant differences in AE (RR\u2009=\u20091.08, 95% CI\u2009=\u20090.97\u20131.21,\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.17,\n                      <jats:italic>I<\/jats:italic>\n                      <jats:sup>\n                        <jats:italic>2<\/jats:italic>\n                      <\/jats:sup>\n                      \u2009=\u200926%) or SAE (RR\u2009=\u20090.94, 95% CI\u2009=\u20090.80\u20131.11,\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.49,\n                      <jats:italic>I<\/jats:italic>\n                      <jats:sup>\n                        <jats:italic>2<\/jats:italic>\n                      <\/jats:sup>\n                      \u2009=\u20090) between the stem cell-based therapy group and the control group. In addition, MSC-derived EVs and secretomes demonstrated preliminary efficacy in the treatment of ARDS (RR\u2009=\u20090.63, 95% CI\u2009=\u20090.46\u20130.86,\n                      <jats:italic>p<\/jats:italic>\n                      \u2009=\u20090.003,\n                      <jats:italic>I<\/jats:italic>\n                      <jats:sup>\n                        <jats:italic>2<\/jats:italic>\n                      <\/jats:sup>\n                      \u2009=\u200940%).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Stem cell-based therapy significantly reduced mortality within one month and was well tolerated in ARDS patients. Given the limited sample size of included studies, the efficacy of stem cell-based therapy in patients with ARDS needs to be validated in further larger and more rigorous randomized controlled trials.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13287-025-04644-4","type":"journal-article","created":{"date-parts":[[2025,9,29]],"date-time":"2025-09-29T13:22:26Z","timestamp":1759152146000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Efficacy and safety of mesenchymal stem\/stromal cells and their derived extracellular vesicles for acute respiratory distress syndrome: a systematic review and meta-analysis"],"prefix":"10.1186","volume":"16","author":[{"given":"Yaxin","family":"Wu","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruonan","family":"Xu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuanyuan","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kai","family":"Liu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tao","family":"Yang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ming","family":"Shi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fu-Sheng","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhe","family":"Xu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,9,29]]},"reference":[{"issue":"10300","key":"4644_CR1","doi-asserted-by":"publisher","first-page":"622","DOI":"10.1016\/S0140-6736(21)00439-6","volume":"398","author":"NJ Meyer","year":"2021","unstructured":"Meyer NJ, Gattinoni L, Calfee CS. 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