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2023, Vol. 27 ›› Issue (19): 3052-3060

Recent advances of engineered exosomes and challenges on clinical translational research

Zhang Qi, Yu Mei, Liu Lei, Tian Weidong   

  1. National Engineering Laboratory for Oral Regenerative Medicine, West China School of Stomatology, Sichuan University, Chengdu 610041, Sichuan Province, China

  • Received:2022-07-14 Accepted:2022-08-29 Online:2023-07-08 Published:2022-11-28

  • Contact: Yu Mei, PhD, Associate professor, National Engineering Laboratory for Oral Regenerative Medicine, West China School of Stomatology, Sichuan University, Chengdu 610041, Sichuan Province, China

  • About author:Zhang Qi, Master candidate, National Engineering Laboratory for Oral Regenerative Medicine, West China School of Stomatology, Sichuan University, Chengdu 610041, Sichuan Province, China

  • Supported by:

    Key Technology Research and Development Program of Sichuan Province, No. 2019YFS0312 (to YM); Applied Basic Research Project of Sichuan Provincial Science and Technology Program, No. 2020YJ0278 (to LL); National Natural Science Foundation of China, No. U21A20369 (to TWD)


Abstract: BACKGROUND: Currently, exosomes were widely attracted as a new form of drug carrier by many researchers. Based on the modification by different bioengineering techniques, natural exosomes were engineered to obtain the enhanced exosomal characteristics and functions.  
OBJECTIVE: To review the preparation strategies, research progress and challenges in clinical translation of engineered exosomes.
METHODS: We searched the articles on PubMed database and FDA online statements with the key words of “extracellular vesicles, exosomes, drug delivery, engineering, engineered, treatment, clinical translation, scale production, isolation, characterization, quality control, storage, safety” in English. Finally, 73 articles and 1 statement met the criteria for review.  
RESULTS AND CONCLUSION: (1) Engineered exosomes can be produced by cell engineering and exosome engineering. The enhanced properties of engineered exosomes manufactured by the two strategies have been verified in basic research, which proves that they have great clinical application prospects. However, both of them have a series of problems such as biosafety and low drug loading efficiency that need to be solved. (2) Engineered exosomes have been proven to have great clinical application potential in various fields such as tumor, cardiovascular disease, tissue regeneration and repair, and nervous system diseases, and have shown better therapeutic effect and targeting ability than natural exosomes. (3) Clinical transformation of engineered exosomes faces many problems and challenges. All kinds of common cells can be used for exosome production and manufacturing. Changes in cell number and culture condition will lead to variation in exosomes. Expanding the scale of cell culture is the most direct method for mass production of exosomes. Different extraction methods will affect the yield and the homogeneity of exosome. The methods on scale culture, isolation and extraction need to be standardized. Characterization and quantification can predict the expected therapeutic potential of drug-loaded exosome systems. It is necessary to further develop gold standards for the quantification of exosomes and the description of molecular and physical characteristics. Exosome products require additional quality control to ensure that the exosome end products meet key quality attributes. Freeze-drying is most conducive process to the commercialize exosome therapeutic drugs. Guideline for the safety and efficacy of exosomes product has not been issued yet, and it is necessary to improve existing methods or find new methods to prove the safety and efficacy of engineered exosomes. (4) Although none of the engineered exosomes has been officially clinically applied yet, their therapeutic potential is indisputable. There is still a long way to go before commercial engineered exosome products are ready for the market.

Key words: exosome, bioengineering, engineered exosome, clinical translation, scale production, isolation and purification, ingredient characterization, quality control, storage stability, product safety


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