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.