Integrative Biomedical Research
Integrative Biomedical Research (Journal of Angiotherapy) | Online ISSN 3068-6326
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Volume 10 Number 1 2026
REVIEWS (Open Access)
Extracellular Vesicles as Diagnostic and Therapeutic Tools: Closing the Translational Gap
Betty Fitriyasti 1, Siska Ferilda 2, Widia Sari 3*
Integrative Biomedical Research 10 (1) 1-8 https://doi.org/10.25163/biomedical.10110886
Submitted: 17 March 2026 Revised: 03 May 2026 Accepted: 14 May 2026 Published: 16 May 2026
Abstract
Extracellular vesicles (EVs) have moved from being dismissed as inert cellular debris to being recognized as active, evolutionarily conserved carriers of intercellular information — a shift that now underpins two overlapping clinical ambitions: non-invasive liquid biopsy diagnostics and engineered, cell-free drug delivery. Yet, despite an expanding preclinical literature, few EV products have reached routine practice. We conducted a narrative, informed synthesis of peer-reviewed literature, supplemented by registry data from ClinicalTrials.gov, focusing on EV biology, isolation methodology, single-vesicle diagnostics, bioengineering, and regulatory frameworks. Synthesis of more than one hundred registered interventional trials, together with comparative isolation and bioengineering data, shows that mesenchymal stem cell-derived EVs dominate the therapeutic pipeline, that single-EV digital platforms (eSimoa, ddSEE, nFCM) now resolve rare oncogenic subpopulations once masked by bulk assays, and that tangential flow filtration and emerging passive-concentration platforms are gradually displacing ultracentrifugation as the scalable isolation standard. Closing the translational gap will depend less on further proof-of-concept biology and more on harmonized potency assays, cGMP-compatible bioprocessing, and converging regulatory pathways across major jurisdictions.
Keywords: extracellular vesicles; exosomes; liquid biopsy; drug delivery; translational medicine; single-vesicle profiling; regulatory science
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