ABSTRACT
@#The concept of extracellular vesicles(EV) was proposed in 2011 by the International Society for Extracellular Vesicles(ISEV),and EV can be widely used in various fields of disease treatment as therapeutic drugs and drug delivery carriers.The therapy based on EV may become a new model of disease treatment in addition to traditional drug therapy and cell therapy-EV cell-free therapy.As a vector,compared with viral vector and synthetic non viral vector,EV have unique advantages and great potential.However,EV have some challenges in clinical transformation because of their unique biological properties.Moreover,this field is relatively new,and there are no relevant policies and regulations specifically for EV therapy.By collecting information from ClinicalTrials.gov platform,this paper summarized the research progress based on EV therapy,put forward suggestions for the existing regulatory system,discussed the general principles of EV non clinical research,pharmaceutical research,pharmacodynamics and pharmacokinetics research,safety evaluation and other non clinical evaluation strategies,so as to provide reference for the formulation of non clinical evaluation research scheme based on EV therapy.