Chinese Journal of Tissue Engineering Research ›› 2025, Vol. 29 ›› Issue (1): 202-210.doi: 10.12307/2025.001

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Application and regulatory challenges of organoid technology in medical field

Cheng Weilu1, Wang Zehua1, Zhang Yidan2, Liu Yinghui1   

  1. 1Department of Clinical and Biostatistics, Center for Medical Device Evaluation, NMPA, Beijing 100081, China; 2GBA Center for Medical Device Evaluation and Inspection, NMPA, Shenzhen 518045, Guangdong Province, China
  • Received:2023-10-30 Accepted:2023-12-18 Online:2025-01-08 Published:2024-05-20
  • About author:Cheng Weilu, PhD, Senior engineer, Department of Clinical and Biostatistics, Center for Medical Device Evaluation, NMPA, Beijing 100081, China

Abstract: BACKGROUND: 3D organoids have characteristics that resemble physiological tissues and to some extent mimic organ function, making them excellent models for applications ranging from basic development/stem cell research to personalized medicine.
OBJECTIVE: To review and discuss the types of diseases and application areas such as tumor modeling that organoids can be applied to, as well as their regulatory status and challenges.
METHODS: With “organoid, stem cell, disease model, 3D printing technology, medical field” as Chinese and English search terms, we searched PubMed, Elsevier, WanFang, and CNKI databases to summarize and analyze organoid products at home and abroad, summarize the application of organoid technology in the medical field, and prospect the future development of organoid products in the medical field.
RESULTS AND CONCLUSION: Organoids can break the limitations of traditional cell and animal models, avoid the ethical problems existing in clinical research, and have a high similarity to the source organ, a more similar performance to the physiology and pathology of human systems, and genetic stability, which has great advantages in current research. Organoids have been applied in the following fields: efficacy evaluation studies (preclinical models), including intestinal organoids, kidney organoids, liver organoids, gallbladder organoids, lung organoids, brain organoids, heart organoids, skin organoids, and reproductive system organoids; research on infectious diseases; cancer research and precision therapy; regenerative medicine; immune organoids. Although the United States, the European Union and China do not have perfect regulatory provisions, they are trying to promote the formulation of organoid regulatory laws and regulations. In China, although no organoid medical device products have been listed for the time being, its related regenerative medicine products have made breakthroughs.

Key words: organoid, stem cell, disease model, 3D printing technology, medical field, review

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