Tabriz University of Medical Sciences BioImpacts 2228-5652 15 1 2025 01 19 Safety and efficacy of extracellular vesicles in individuals with cancer; A systematic review 30501 30501 10.34172/bi.30501 EN Hila Asham https://orcid.org/0009-0003-5915-4805 Negin Jafari Elham Mohamadrezapour Hossein Bannazadeh Baghi Hosein Eslami Taher Entezari-Maleki https://orcid.org/0000-0003-3653-3653 Journal Article 10.34172/bi.30501 2024 05 13 2024 07 24 Introduction: Extracellular vesicles (EVs) are crucial in intercellular signaling pathways. Since cancer has had a significant impact on global health as the second leading cause of death, this study aimed to systematically review the literature on the efficacy and safety of EVs in this setting. Methods: A systematic literature review was performed on MEDLINE, Embase, the Cochrane Library, and ClinicalTrials.gov from database inception until August 10th, 2023. Based on PICOS, the inclusion criteria were: individuals with cancer treated with EVs compared to control among clinical studies. Results: EVs administered to 46 individuals with cancer. Most studies revealed significant clinical benefits after treatment. Results also demonstrated that EVs are safe without major adverse events (AEs). Conclusion: The use of EVs may provide potential therapeutic benefits for treating cancer. Further, well-designed randomized clinical trials (RCTs) are needed to provide robust evidence for supporting the clinical use of EVs in this setting.