Safety of intravenous mesenchymal stem cell therapy: a meta-analysis of randomized controlled trials

Résumé fourni par la source

Previous preclinical research and human trials have demonstrated that intravenous cell administration is a safe and successful treatment method for improving the quality of life in patients with a variety of illnesses. The purpose of this study was to evaluate the safety profile of mesenchymal stem cells administered intravenously. We explored PubMed, ScienceDirect, Web of Science, ClinicalTrials.gov, and the Cochrane Library for published research from their creation through December 2024, following PRISMA 2020 guidelines. Two researchers independently assessed the study’s inclusion and exclusion criteria, data extraction, and risk of bias assessment. Our meta-analysis includes 36 studies on mesenchymal stem cell therapy by intravenous method. The safety profile of mesenchymal stem cell therapy was evaluated across various adverse event categories using meta-analyses of randomized controlled trials. Twenty-two randomized controlled trials assessed general disorders and administration site conditions, showing no statistically significant increase in adverse event risk in the mesenchymal stem cell group compared to controls (log odds ratio [OR]: 0.29, 95% confidence interval [CI]: –0.15 to 0.73, P = 0.201). Similarly, analyses of musculoskeletal/connective tissue disorders (four randomized controlled trials, log OR: –0.26, 95% CI: –1.81 to 1.29, P = 0.742) and renal/urinary disorders (five randomized controlled trials, log OR: 0.30, 95% CI: –0.59 to 1.19, P = 0.511) revealed non-significant results. Conversely, a statistically significant increase in nervous system disorders was observed (thirteen randomized controlled trials, log OR: 0.54, 95% CI: –0.05 to 1.13, P = 0.072). Infection-related adverse events, evaluated in twenty randomized controlled trials, showed a slight but significant elevated risk in the mesenchymal stem cell group (log OR: –0.32, 95% CI: –0.61 to -0.02, P = 0.036). Gastrointestinal disorders (five randomized controlled trials, log OR: 0.00, 95% CI: –0.33 to 0.33, P = 0.988), respiratory/thoracic disorders (eight randomized controlled trials, log OR: –0.12, 95% CI: –0.67 to 0.42, P = 0.652), and immune system disorders (three randomized controlled trials, log OR: –0.97, 95% CI: –2.42 to 0.49, P = 0.193) did not show significant risk increases. Injury and procedural complications (five randomized controlled trials) also demonstrated a non-significant trend. Heterogeneity was minimal across all analyses, and no substantial publication bias or influential studies were identified. While most findings support the safety of mesenchymal stem cell therapies, significant results for nervous system and infection-related adverse events warrant further investigation. We conclude that intravenous delivery of mesenchymal stem cells is safe for many conditions. However, large-scale randomized controlled trials are required to confirm the findings.

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