Mesenchymal stromal cell-derived extracellular vesicles in regenerative medicine: Standardisation, bioengineering and clinical translation.

ABSTRACT: Mesenchymal stromal cell-derived extracellular vesicles (MSC-EVs) have emerged as promising cell-free therapeutics that recapitulate key paracrine functions of MSCs whilst mitigating limitations of viable-cell therapies. Clinical translation is hindered by inconsistent dose metrics, lack of validated potency assays, and manufacturing complexities. Here we review advances in MSC-EV standardisation, source and culture determinants, engineering and delivery platforms, and clinical applications, exemplified by chronic wound healing. We operationalise dual-metric dosing (particles plus protein) linked to mechanism-aligned potency assays, adopt a route-aware exposure-response framework to guide delivery strategies, and propose decision matrices aligning MSC sources and bioprocesses with i

SUBMITTER: Shimizu Y 

PROVIDER: S-EPMC12796862 | biostudies-literature | 2026 Mar

REPOSITORIES: biostudies-literature