Department of Family Medicine, Rowan-Virtua School of Osteopathic Medicine, Stratford, NJ.
Department of Epidemiology and Surgery, University of Alabama at Birmingham, Birmingham, AL.
Transplantation. 2024 Feb 1;108(2):369-373. doi: 10.1097/TP.0000000000004679. Epub 2023 May 29.
Xenotransplantation clinical trials may begin soon. A persistent risk of xenotransplantation, known for decades, is the possibility that a xenozoonotic infection could be transferred from a xenograft to its recipient and then to other human contacts. Because of this risk, guidelines and commentators have advocated for xenograft recipients to agree to either long-term or lifelong surveillance mechanisms.
For the past few decades, one solution that has been proposed to ensure that xenograft recipients will comply with surveillance protocols is the use of a heavily modified Ulysses contract, which we review.
These contracts are most often used in psychiatry, and their application to xenotransplantation has been espoused several times with minimal criticism.
In this article, we argue against the applicability of Ulysses contracts in xenotransplantation based upon (1) the telos of the advance directive that may not be applicable to this clinical context, (2) the suspect nature of enforcing Ulysses contracts in xenotransplantation, and (3) the ethical and regulatory hurdles that such enforcement would require. Although our focus is on the US regulatory landscape in preparation for clinical trials, there are applications globally.
异种移植临床试验可能很快开始。几十年来，异种移植一直存在一个持续的风险，即一种异种动物传染病可能从异种移植物转移到其受者身上，然后再转移到其他人类接触者身上。由于这种风险，指南和评论员主张异种移植物受者同意长期或终身监测机制。
在过去的几十年中，为了确保异种移植物受者遵守监测协议，人们提出了一种解决方案，即使用经过大量修改的尤利西斯合同，我们对其进行了回顾。
这些合同最常用于精神病学，并且已经多次倡导将其应用于异种移植，几乎没有受到批评。
在本文中，我们根据以下几点反对在异种移植中使用尤利西斯合同的适用性：(1) 预先指示的目的可能不适用于这种临床情况；(2) 在异种移植中强制执行尤利西斯合同的可疑性；(3) 这种执行所需的伦理和监管障碍。尽管我们的重点是为临床试验做准备的美国监管格局，但在全球范围内也有应用。
