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Background <p>Acute respiratory distress syndrome (ARDS) is closely related to public health because of its consistently high rates of mortality and morbidity. Mesenchymal stem/stromal cells (MSCs) treatment has become a promising therapeutic approach due to the regenerative and immunomodulatory qualities of it. Based on an umbrella review methodology, we seek to thoroughly integrate the available data on the effectiveness and safety of MSCs treatment for ARDS from various angles.</p> Methods <p>This study was conducted following PRISMA 2020 standards. PubMed, Embase, Web of Science, and Cochrane Library databases were searched thoroughly between 1995 and October 2025 in order to find umbrella reviews that addressed the use of MSC treatment for ARDS. Review Manager and Stata MP software were used to carry out a meta-analysis of outcome measures. The methodological quality of the included research was assessed using the AMSTAR-2 scale, while the risk of bias in systematic reviews was assessed using the ROBIS tool. The certainty of the evidence was assessed using the GRADE procedure.</p> Results <p>A total of 15 systematic reviews were included, of which 10 were related to randomized clinical trials (RCTs) and 5 were related to controlled preclinical studies. MSCs therapy may lower the death rate of ARDS patients (risk ratio [RR] = 0.79, 95% confidence interval [CI] 0.66–0.96) with moderate certainty of evidence, according to findings from systematic evaluations of clinical studies. With low certainty of evidence, adverse events did not significantly differ between the groups receiving MSCs therapy and those receiving conventional treatment (RR = 0.98, 95% CI 0.85–1.12). In controlled preclinical studies, ARDS animal models treated with MSCs had lower mortality rates and lower lung injury score (RR = 0.50, 95% CI 0.40–0.62; standardized mean difference [SMD] = − 3.19, 95% CI − 4.33 to − 2.05), which was accompanied by low credibility and significant heterogeneity.</p> Conclusions <p>Our umbrella review shows the potential benefit of MSCS treatment in reducing mortality among ARDS patients, particularly in studies of UC-MSCs, and the possibility of reducing the degree of lung injury in ARDS animal models. The safety of MSCs has been validated in clinical trials, although the certainty of evidence is low. Our umbrella review clarifies the importance of standardized treatment protocols and clinical trials for confirming the efficacy of MSCs treatment and facilitating its clinical translation. However, the current evidence was limited by the substantial heterogeneity with very low certainty and requires confirmation in adequately powered, standardized, multicenter RCTs to promote translational application to human patients.</p> <p><i>Trial registration</i> Systematic Review Registration: PROSPERO registration CRD420251267987 and CRD420251268056.</p>

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The effectiveness and safety of mesenchymal stromal/stem cell therapy for acute respiratory distress syndrome: an umbrella review

  • 期刊论文

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  • 发表日期：

    2026年7月31日

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  • Wenchi Li,
  • Feifei Wang,
  • Yiqing Lin,
  • Jinwei Shang,
  • Shuyue Sheng,
  • Feng Zhu

摘要

Background

Acute respiratory distress syndrome (ARDS) is closely related to public health because of its consistently high rates of mortality and morbidity. Mesenchymal stem/stromal cells (MSCs) treatment has become a promising therapeutic approach due to the regenerative and immunomodulatory qualities of it. Based on an umbrella review methodology, we seek to thoroughly integrate the available data on the effectiveness and safety of MSCs treatment for ARDS from various angles.

Methods

This study was conducted following PRISMA 2020 standards. PubMed, Embase, Web of Science, and Cochrane Library databases were searched thoroughly between 1995 and October 2025 in order to find umbrella reviews that addressed the use of MSC treatment for ARDS. Review Manager and Stata MP software were used to carry out a meta-analysis of outcome measures. The methodological quality of the included research was assessed using the AMSTAR-2 scale, while the risk of bias in systematic reviews was assessed using the ROBIS tool. The certainty of the evidence was assessed using the GRADE procedure.

Results

A total of 15 systematic reviews were included, of which 10 were related to randomized clinical trials (RCTs) and 5 were related to controlled preclinical studies. MSCs therapy may lower the death rate of ARDS patients (risk ratio [RR] = 0.79, 95% confidence interval [CI] 0.66–0.96) with moderate certainty of evidence, according to findings from systematic evaluations of clinical studies. With low certainty of evidence, adverse events did not significantly differ between the groups receiving MSCs therapy and those receiving conventional treatment (RR = 0.98, 95% CI 0.85–1.12). In controlled preclinical studies, ARDS animal models treated with MSCs had lower mortality rates and lower lung injury score (RR = 0.50, 95% CI 0.40–0.62; standardized mean difference [SMD] = − 3.19, 95% CI − 4.33 to − 2.05), which was accompanied by low credibility and significant heterogeneity.

Conclusions

Our umbrella review shows the potential benefit of MSCS treatment in reducing mortality among ARDS patients, particularly in studies of UC-MSCs, and the possibility of reducing the degree of lung injury in ARDS animal models. The safety of MSCs has been validated in clinical trials, although the certainty of evidence is low. Our umbrella review clarifies the importance of standardized treatment protocols and clinical trials for confirming the efficacy of MSCs treatment and facilitating its clinical translation. However, the current evidence was limited by the substantial heterogeneity with very low certainty and requires confirmation in adequately powered, standardized, multicenter RCTs to promote translational application to human patients.

Trial registration Systematic Review Registration: PROSPERO registration CRD420251267987 and CRD420251268056.