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.

中文翻译：

---

管理停止生物时间的新技术：为移植中人体器官的长期生物保存做准备


从取回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活力，也许是无限期的。这些技术可以将移植转变为没有地理或时间限制的预定程序，允许器官评估和受体的潜在预处理。然而，高级生物保存与长期储存血管化器官后再复活的安全性和有效性将需要新的监管监督，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，也没有接受过评估纵器官的设备。尽管美国食品药品监督管理局 （Food and Drug Administration） 最适合提供这一过程监督，但该机构迄今一直拒绝监督器官质量，并将血管化器官排除在人体细胞、组织以及基于细胞和基于组织的产品的监督框架之外。整合先进的生物保存技术将需要新的器官保存、储存和复活设施，以及关于立即使用与保存器官、国家分配和集中器官库治理的道德指导。实现先进生物保鲜的长期利益需要预测必要的法律和道德监督工具，这个过程应该现在就开始。