Center for Health Management, Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital, Chengdu, China.
Medical Administration Department, Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital, Chengdu, China.
Xenotransplantation. 2020 May;27(3):e12601. doi: 10.1111/xen.12601. Epub 2020 May 5.
Given the persistence and the worldwide shortage of organs from both the deceased and living donors for clinical transplantation, pig organs or tissues hold immense promises for the patients on the waiting list, and xenotransplantation is deemed as one of the solutions to the organ shortage crisis. Indeed, the emerging gene editing technologies, such as CRISPR/Cas9, have led to tremendous progress in the generation of genetically modified pigs to overcome many barriers associated.
We presented a description of the xenotransplantation regulations in China and the related products.
Several groups in China have successfully generated transgenic pigs with the elimination of immune rejection or coagulation-related genes, and both pre-clinical and clinical studies have been reported. However, the pre-clinical evaluation and clinical application of porcine xenotransplantation raises ethical and regulatory considerations. Herein, in this review, we will summarize and discuss the progress in xenotransplantation in China and xenotransplantation-related products from the regulatory perspective.
There has been remarkable progress in both the genetically modified pigs and pre-clinical studies in China, and China will be the first country to successfully fulfill the xenotransplantation from pig organ to human in the near future.
鉴于供临床移植的已故和活体捐献者的器官持续短缺且在全球范围内短缺，猪器官或组织为等候名单上的患者带来了巨大的希望，异种移植被认为是解决器官短缺危机的方法之一。事实上，新兴的基因编辑技术，如 CRISPR/Cas9，在生成克服许多相关障碍的基因修饰猪方面取得了巨大进展。
我们介绍了中国异种移植法规和相关产品的情况。
中国的几个研究小组已经成功地生成了消除免疫排斥或凝血相关基因的转基因猪，并且已经报道了临床前和临床研究。然而，猪异种移植的临床前评估和临床应用引发了伦理和监管方面的考虑。在此，在本综述中，我们将从监管角度总结和讨论中国异种移植的进展和异种移植相关产品。
中国在基因修饰猪和临床前研究方面都取得了显著进展，中国将成为不久的将来第一个成功实现猪器官异种移植到人体的国家。
