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February 11, 2026International Journal of Molecular Sciences15 citationsOpen Access

Therapeutic Potential of Extracellular Vesicles: From Biogenesis, Isolation and Molecular Characterization to Addressing Translational Gaps and Regulatory Barriers

DPDragan PrimoracPBPetar BrlekLBLuka Bulić

Key Points

  • This review aims to summarize the biogenesis, characterization, and clinical applications of extracellular vesicles in human disease.
  • Comprehensive literature review on the biogenesis of extracellular vesicles.
  • Analysis of various classes of extracellular vesicles and their molecular composition.
  • Focus on recent advancements in isolation and profiling techniques for extracellular vesicles.
  • Discussion of clinical applications, particularly in regenerative medicine and oncology.
  • Extracellular vesicles are identified as key players in intercellular communication.
  • Highlighting the clinical potential of MSC-derived EVs for therapeutic applications.
  • Emphasis on the necessity of regulatory oversight in translating EVs into clinical settings.

Abstract

Extracellular vesicles (EVs) have emerged as essential mediators of intercellular communication, transporting a complex repertoire of lipids, proteins, and nucleic acids that mirror the physiological and pathological status of their parent cells. This review provides a comprehensive overview of EVs from their biogenesis and molecular composition to their translational potential in human disease. This review outlines the major classes of EVs, including exosomes, microvesicles, apoptotic bodies, and oncosomes, together with recent developments in their isolation, molecular characterization, and omics-based profiling. Special focus is given to the role of EVs in viral infection, inflammation, and immune regulation, as well as their contribution to disease development and cancer biology. Moreover, we highlight the emerging clinical applications of mesenchymal stem cell-derived EVs (MSC-EVs) in regenerative medicine and oncology, alongside the therapeutic modulation of EV signaling by photobiomodulation (PBM). Finally, we address key translational challenges related to standardization, scalability, and regulatory validation. As exosome-based therapeutics fall under strict FDA and EMA oversight, their translation further depends on harmonized quality controls and robust safety evaluation. By integrating molecular mechanisms with clinical applications, this review emphasizes the transformative potential of EVs as next-generation diagnostic and therapeutic tools in precision medicine.

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Cite This Study

Primorac et al. (2026) studied this question.

synapsesocial.com/papers/698c1c8e267fb587c655f1a2https://doi.org/10.3390/ijms27041676
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