Department of Surgery, University of Minnesota, Minneapolis, Minnesota, USA.
Department of Surgery, Duke University, Durham, North Carolina, USA.
Am J Transplant. 2023 Sep;23(9):1290-1299. doi: 10.1016/j.ajt.2023.05.010. Epub 2023 May 20.
In June 2022, the US Food and Drug Administration Center for Biologics Evaluation and Research held the 73rd meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee for public discussion of regulatory expectations for xenotransplantation products. The members of a joint American Society of Transplant Surgeons/American Society of Transplantation committee on xenotransplantation compiled a meeting summary focusing on 7 topics believed to be key by the committee: (1) preclinical evidence supporting progression to a clinical trial, (2) porcine kidney function, (3) ethical aspects, (4) design of initial clinical trials, (5) infectious disease issues, (6) industry perspectives, and (7) regulatory oversight.
2022 年 6 月，美国食品和药物管理局生物制品评估和研究中心召开了第 73 次细胞、组织和基因治疗咨询委员会会议，公开讨论了对异种移植产品的监管预期。一个由美国移植外科学会/美国移植学会异种移植委员会联合组成的委员会编写了一份会议总结，重点关注委员会认为的 7 个关键主题：（1）支持临床试验进展的临床前证据，（2）猪肾脏功能，（3）伦理方面，（4）初始临床试验设计，（5）传染病问题，（6）行业观点，以及（7）监管监督。
