Pruett Timothy L, Wolf Susan M, McVan Claire Colby, Lyon Peter, Capron Alexander M, Childress James F, Evans Barbara J, Finger Erik B, Hyun Insoo, Isasi Rosario, Marchant Gary E, Maynard Andrew D, Oye Kenneth A, Toner Mehmet, Uygun Korkut, Bischof John C
Department of Surgery and Internal Medicine, University of Minnesota School of Medicine, Minneapolis, MN, USA; NSF Engineering Research Center for Advanced Technologies for Preservation of Biological Systems (ATP-Bio), Minneapolis, MN, USA.
NSF Engineering Research Center for Advanced Technologies for Preservation of Biological Systems (ATP-Bio), Minneapolis, MN, USA; University of Minnesota Law School, Minneapolis, MN, USA; Department of Medicine, University of Minnesota, Minnesota, MN, USA.
Am J Transplant. 2025 Feb;25(2):269-276. doi: 10.1016/j.ajt.2024.09.017. Epub 2024 Sep 19.
Time limits on organ viability from retrieval to implantation shape the US system for human organ transplantation. Preclinical research has demonstrated that emerging biopreservation technologies can prolong organ viability, perhaps indefinitely. These technologies could transform transplantation into a scheduled procedure without geographic or time constraints, permitting organ assessment and potential preconditioning of the recipients. However, the safety and efficacy of advanced biopreservation with prolonged storage of vascularized organs followed by reanimation will require new regulatory oversight, as clinicians and transplant centers are not trained in the engineering techniques involved or equipped to assess the manipulated organs. Although the Food and Drug Administration is best situated to provide that process oversight, the agency has until now declined to oversee organ quality and has excluded vascularized organs from the oversight framework of human cells, tissues, and cellular-based and tissue-based products. Integration of advanced biopreservation technologies will require new facilities for organ preservation, storage, and reanimation plus ethical guidance on immediate organ use versus preservation, national allocation, and governance of centralized organ banks. Realization of the long-term benefit of advanced biopreservation requires anticipation of the necessary legal and ethical oversight tools and that process should begin now.
从器官获取到植入的器官存活时间限制塑造了美国人体器官移植系统。临床前研究表明，新兴的生物保存技术可以延长器官存活时间，甚至可能无限期延长。这些技术可以将移植转变为一种不受地理或时间限制的常规程序，允许对器官进行评估并对接受者进行潜在的预处理。然而，先进的生物保存技术在长时间保存血管化器官后再使其复苏的安全性和有效性将需要新的监管，因为临床医生和移植中心没有接受过相关工程技术的培训，也没有配备评估经过处理的器官的设备。尽管美国食品药品监督管理局最适合提供这一过程的监管，但该机构至今拒绝监管器官质量，并将血管化器官排除在人体细胞、组织以及基于细胞和组织的产品的监管框架之外。整合先进的生物保存技术将需要新的器官保存、存储和复苏设施，以及关于器官立即使用与保存、全国分配和集中式器官库管理的伦理指导。要实现先进生物保存技术的长期效益，需要提前准备好必要的法律和伦理监管工具，这一过程现在就应该开始。
