Clinical translation of mesenchymal stromal cell extracellular vesicles: Considerations on scientific rationale and production requisites.

The present paper is a commentary to 'Identification and characterization of hADSC-derived exosome proteins from different isolation methods' (Huang et al. 2021; 10.1111/jcmm.16775). Given the enthusiasm for the potential of mesenchymal stromal cell-derived extracellular vesicles (MSC-EVs), some considerations deserve attention as they move through successive stages of research and application into humans. We herein remark the prerequisite of generating that evidence ensuring a high consistency in safety, composition and biological activity of the intended MSC-EV preparations, and the suitability of disparate isolation techniques to produce efficacious EV preparations and fulfil requirements for standardized clinical-grade biomanufacturing.