Revisiting the Use of Ulysses Contracts in Xenotransplantation
- PMID: 37246302
- DOI: 10.1097/TP.0000000000004679
Revisiting the Use of Ulysses Contracts in Xenotransplantation
Abstract
Background: 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.
Methods: 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.
Results: These contracts are most often used in psychiatry, and their application to xenotransplantation has been espoused several times with minimal criticism.
Conclusions: 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.
Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.
Conflict of interest statement
The authors declare no funding or conflicts of interest.
References
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- ClinicalTrials.gov . Porcine kidney xenotransplantation in patients with end-stage kidney disease. Available at https://clinicaltrials.gov/ct2/show/NCT05340426?term=xenotransplantation... . Accessed March 1, 2023.
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