Extracellular Vesicle-Based Drug Overview: Research Landscape, Quality Control, and Nonclinical Evaluation Strategies

    Gangling Xu, Jing Jin, Zhihao Fu, Guangming Wang, Lei Xinhua, Jun Xu, Junzhi Wang
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    Studysummary This review highlights the potential of extracellular vesicle-based therapies for treating various diseases, but it also notes challenges like the lack of regulatory guidelines that hinder their clinical development.
    Our plain-language summary. Not medical advice or a treatment recommendation. Consult a qualified healthcare professional before changing treatment. Full disclaimer
    Extracellular vesicles (EVs) have emerged as promising therapeutic agents due to their ability to transfer bioactive cargo to target cells, offering potential treatments for various diseases. Despite their promise, challenges such as understanding mechanisms, engineering modifications, and establishing quality control hinder their clinical translation. Currently, no specific regulatory guidelines exist for EV-based drugs, complicating their development. This review highlights the current research landscape, quality control strategies, and nonclinical evaluation of EV-based drugs, aiming to expedite their clinical application and benefit patients.
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