Requirements for human pluripotent stem cell derived small extracellular vesicles

Abstract Small extracellular vesicles derived from human pluripotent stem cells (hPSC‐sEVs) have shown great application potential in regenerative medicine. To standardise its research and clinical application, the first set of guidelines on hPSC‐sEVs in China ‘Requirements for human pluripotent stem cell derived small extracellular vesicles’ was released by the Chinese Research Hospital Association on 28 December 2021 and came into effect on 1 January 2022. It was jointly drafted and agreed upon by the experts from the Chinese Society of Extracellular Vesicles. This standard specifies the technical requirements, test methods and regulations, packaging, instructions for use, labelling, storage, transportation, and waste handling for hPSC‐sEVs, which apply to the production and quality control of hPSC‐sEVs. We hope that the publication of these guidelines will make it one step closer to international standardisation of hPSC‐sEVs for research and application.