类器官技术在医疗领域的应用和监管挑战.

Application and regulatory challenges of organoid technology in medical field.

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. [ABSTRACT FROM AUTHOR]

背景: 3D类器官具有类似于生理组织并在-定程度上模仿器官功能的特点, 使其成为从基础发育/干细胞研究到个性化医疗等应用的出色 模型. 目的: 综述并讨论类器官可应用的疾病类型和肿瘤建模等应用领域, 以及其监管现状和挑战. 方法: 以“类器官, 干细胞, 疾病模型, 3D打印技术, 医疗领域”为中文检索词, 以“organoid, stem cell, disease model, 3D printing technology, medical field”为英文检索词, 检索PubMed、Elsevier、万方、中国知网等数据库, 对国内外类器官产品进行汇总分析, 总结 出类器官技术在医疗领域中的应用情况, 并对类器官产品在医疗领域的未来发展进行展望. 结果与结论: 类器官组织可以打破传统细胞和动物模型的局限性, 规避临床研究中存在的伦理问题, 与源器官具有高度相似性, 与人类 系统的生理和病理具有更加相似的表现且遗传稳定, 在当前研究中具有极大的优势. 类器官在以下领域已得到应用: 药效评价研究(临床 前模型), 包括肠道类器官、肾脏类器官、肝脏类器官、胆囊类器官、肺类器官、脑类器官、心脏类器官、皮肤类器官、生殖系统类器官 等; 传染病研究; 肿瘤研究及精准治疗; 再生医学; 免疫类器官. 美国、欧盟和中国虽暂无完善的监管规定, 但均在努力推进类器官监管 法律法规的制定. 在国内, 类器官医疗器械产品虽暂无已上市产品, 但与其相关的再生医学产品已有突破性进展. [ABSTRACT FROM AUTHOR]

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