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Purpose <p>To evaluate the safety and efficacy of mesenchymal stromal/stem cell (MSC)–derived extracellular vesicles (EVs) in human clinical trials across immunomodulatory and regenerative indications.</p> Methods <p>Following Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines, we systematically searched Web of Science, Scopus, and PubMed (from inception to June 20, 2025) and included 24 interventional trials (n, 536). Meta-analyses estimated pooled proportions of serious adverse events (SAEs) and adverse events (AEs), with subgroup analyses by EV source, engineering status, tissue origin, and administration route.</p> Results <p>Across diverse conditions—including COVID-19 acute respiratory distress syndrome (ARDS), Crohn’s perianal fistula, osteoarthritis, and skin aging—the pooled SAE rate was 1.0% (95% CI 0.00–0.02; I<sup>2</sup>, 0%) and AEs 2.0% (95% CI 0.01–0.05; I<sup>2</sup>, 46%). SAE and AE rates did not differ by EV source, engineering, or route. Clinical improvement was reported in most studies, though many were small or non-randomized.</p> Conclusion <p>MSC-EV therapies demonstrate a low incidence of SAEs and promising preliminary efficacy across multiple indications. However, heterogeneity in EV manufacturing, characterization, and trial design limits definitive conclusions. Standardized protocols and large randomized controlled trials are essential to advance clinical translation.</p> Lay Summary <p>Stem cells release tiny healing particles called extracellular vesicles (EVs). We reviewed 24 clinical studies that used these particles for problems like lung injury from COVID-19, Crohn’s fistulas, arthritis, and skin aging. Treatments were very safe, with side effects rare. Many patients improved, especially for inflammation and tissue repair. Because the studies made and used the particles in different ways, results are hard to compare. Bigger, better-standardized studies are needed to confirm benefits and decide the best dose and delivery.</p> Future Work Description <p>Future research should focus on standardizing EV isolation and dosing methods, conducting large-scale randomized controlled trials, and exploring long-term safety and efficacy. Emphasis will also be placed on optimizing engineered EVs and evaluating specific disease-targeted applications to enhance therapeutic outcomes in regenerative and immune-related disorders.</p>

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Efficacy and Safety of Mesenchymal Stromal Cell-derived Extracellular Vesicles: A Systematic Review and Meta-analysis of Human Clinical Trials

  • 期刊论文

  • 发表日期：

    2026年1月7日

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  • Nadiar M. Mussin,
  • Kulyash R. Zhilisbayeva,
  • Akmaral Baspakova,
  • Bibigul K. Karimsakova,
  • Gulzhan A. Tulegenova,
  • Madina A. Kurmanalina,
  • Amin Tamadon

摘要

Purpose

To evaluate the safety and efficacy of mesenchymal stromal/stem cell (MSC)–derived extracellular vesicles (EVs) in human clinical trials across immunomodulatory and regenerative indications.

Methods

Following Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines, we systematically searched Web of Science, Scopus, and PubMed (from inception to June 20, 2025) and included 24 interventional trials (n, 536). Meta-analyses estimated pooled proportions of serious adverse events (SAEs) and adverse events (AEs), with subgroup analyses by EV source, engineering status, tissue origin, and administration route.

Results

Across diverse conditions—including COVID-19 acute respiratory distress syndrome (ARDS), Crohn’s perianal fistula, osteoarthritis, and skin aging—the pooled SAE rate was 1.0% (95% CI 0.00–0.02; I2, 0%) and AEs 2.0% (95% CI 0.01–0.05; I2, 46%). SAE and AE rates did not differ by EV source, engineering, or route. Clinical improvement was reported in most studies, though many were small or non-randomized.

Conclusion

MSC-EV therapies demonstrate a low incidence of SAEs and promising preliminary efficacy across multiple indications. However, heterogeneity in EV manufacturing, characterization, and trial design limits definitive conclusions. Standardized protocols and large randomized controlled trials are essential to advance clinical translation.

Lay Summary

Stem cells release tiny healing particles called extracellular vesicles (EVs). We reviewed 24 clinical studies that used these particles for problems like lung injury from COVID-19, Crohn’s fistulas, arthritis, and skin aging. Treatments were very safe, with side effects rare. Many patients improved, especially for inflammation and tissue repair. Because the studies made and used the particles in different ways, results are hard to compare. Bigger, better-standardized studies are needed to confirm benefits and decide the best dose and delivery.

Future Work Description

Future research should focus on standardizing EV isolation and dosing methods, conducting large-scale randomized controlled trials, and exploring long-term safety and efficacy. Emphasis will also be placed on optimizing engineered EVs and evaluating specific disease-targeted applications to enhance therapeutic outcomes in regenerative and immune-related disorders.