General requirements for the production of extracellular vesicles derived from human stem cells

Author:

Wang Ling12ORCID,Liu Shiyu3,Li Ka4,Ma Aijin56,Hu Chenghu7,Wang Changlin8,Cao Nan69,Zhao Yunpeng12,Fu Ruifeng12,Jia Wenwen1011,Xiang Peng69,Liu Houqi12,Qi Zhongquan13,Zhu Ningwen14,Liang Lingmin61516,Wang Lei61516,Cao Jiani61516,Zhai Peijun17,Zhou Jiaxi618,Wei Jun619,Na Tao20,Wu Jun1516,He Zhiying21,Zhou Guangdong22ORCID,Yu Weifeng22,Wu Jinyan14,Zeng Wen23,Zhang Yong62425,Zhu Lijun26,Fu Boqiang627,Zhang Jingzhong28,Yang Shuwei29,Dai Chengxiang30,Cui Hengmi31,Jing Jianzhong32,Yan Hexin33,He Xiaowen34,Lu Yongbo35,Tong Cailing36,Zhao Tongbiao61516ORCID,Hao Jie61516ORCID,Liu Xialin37,Jin Yan3ORCID,Wang Yue1211

Affiliation:

1. Department of Stem Cells and Regenerative Medicine Center for Translational Medicine, Naval Medical University Shanghai China

2. Shanghai Key Laboratory of Cell Engineering Naval Medical University Shanghai China

3. State Key Laboratory of Oral and Maxillofacial Reconstruction and Regeneration, National Clinical Research Center for Oral Diseases, Shaanxi Key Laboratory of Stomatology, Department of Prosthodontics School of Stomatology, The Fourth Military Medical University Shaanxi China

4. Institute of Clinical Science Zhongshan Hospital, Fudan University Shanghai China

5. Beijing Technology and Business University Beijing China

6. Chinese Society for Stem Cell Research Shanghai China

7. Xi'an Key Laboratory of Stem Cell and Regenerative Medicine Institute of Medical Research, Northwestern Polytechnical University Shaanxi China

8. China Institute of Standardization Beijing China

9. Center for Stem Cell Biology and Tissue Engineering, Key Laboratory for Stem Cells and Tissue Engineering, Ministry of Education Sun Yat‐Sen University Guangzhou China

10. National Stem Cell Resource Transformation Bank Shanghai China

11. Shanghai Institute of Stem Cell Research and Clinical Translation Shanghai China

12. Haimenshengyuan Stem Cell Technology Co. Ltd. Nantong China

13. Guangxi University Nanning China

14. Fudan University Shanghai China

15. National Stem Cell Resource Center, State Key Laboratory of Stem Cell and Reproductive Biology, Institute of Zoology, Institute for Stem Cell and Regeneration, University of Chinese Academy of Sciences Beijing China

16. Beijing Institute for Stem Cell and Regenerative Medicine Beijing China

17. China National Accreditation Center for Conformity Assessment Beijing China

18. Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College Tianjin China

19. Zephyrm Biotechnologies Co. Ltd. Beijing China

20. China Institute for Food and Drug Control Beijing China

21. Institute for Regenerative Medicine, Shanghai East Hospital, School of Life Sciences and Technology, Tongji University, Shanghai, China; Shanghai Engineering Research Center of Stem Cells Translational Medicine Shanghai China

22. Shanghai Jiaotong University Shanghai China

23. Army Military Medical University Chongqing China

24. National Clinical Research Center of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical University Guangzhou China

25. HHLIFE Company Inc. Shenzhen China

26. Institute of Scientific and Technical Information of China Beijing China

27. National Institute of Metrology Beijing China

28. Suzhou Institute of Biomedical Engineering Technology Chinese Academy of Sciences Suzhou China

29. Guangzhou Funeng Gene Co. Ltd. Guangzhou China

30. Cellular Biomedicine Group Ltd Shanghai China

31. Jiangsu Innovation Institute For Biomedicine Nanjing China

32. Shanghai Golden Meditech LifeBank Co. Ltd. Shanghai China

33. Shanghai Celevik Biotechnology Co. Ltd. Shanghai China

34. Origincell Co. Ltd. Shanghai China

35. Guangdong Boxi Biotechnology Co. Ltd. Dongguan China

36. Biotechcomer (Xiamen) Technology Co. Ltd. Xiamen China

37. State Key Laboratory of Ophthalmology, Zhongshan ophthalmic Center Sun Yat‐sen University Guangzhou China

Abstract

Abstract‘General requirements for the production of extracellular vesicles derived from human stem cells’ is the first guideline for stem cells derived extracellular vesicles in China, jointly drafted and agreed upon by experts from the Chinese Society for Stem Cell Research. This standard specifies the general requirements, process requirements, packaging and labelling requirements and storage requirements for preparing extracellular vesicles derived from human stem cells, which is applicable to the research and production of extracellular vesicles derived from stem cells. It was originally released by the China Society for Cell Biology on 30 August 2022. We hope that the publication of this guideline will promote institutional establishment, acceptance and execution of proper protocols, and accelerate the international standardisation of extracellular vesicles derived from human stem cells.

Funder

National Key Research and Development Program of China

National Natural Science Foundation of China

Publisher

Wiley

Subject

Cell Biology,General Medicine

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