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Ethical Analysis of Voluntariness in Pig Kidney Xenotransplant First-in-Human Clinical Trials.

作者信息

Houston Michelle L, Maschke Karen J, Gusmano Michael K, Gordon Elisa J

机构信息

Department of Surgery, Vanderbilt University Medical Center, Nashville, Tennessee, USA.

The Hastings Center for Bioethics, Garrison, New York, USA.

出版信息

Xenotransplantation. 2025 May-Jun;32(3):e70052. doi: 10.1111/xen.70052.

DOI:10.1111/xen.70052
PMID:40407361
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12101099/
Abstract
摘要

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Transplant Patients' Perceptions About Participating in First-in-Human Pig Kidney Xenotransplant Clinical Trials: A Mixed Methods Study.移植患者对参与首例人源猪肾异种移植临床试验的看法:一项混合方法研究
Xenotransplantation. 2025 Jan-Feb;32(1):e70013. doi: 10.1111/xen.70013.
2
World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Participants.《世界医学协会赫尔辛基宣言:涉及人类受试者的医学研究伦理原则》
JAMA. 2025 Jan 7;333(1):71-74. doi: 10.1001/jama.2024.21972.
3
Risky first-in-human clinical trials on medically fragile persons: owning the moral cost.风险较大的首例人体临床试验在体质脆弱人群中开展:承担道德成本。
Theor Med Bioeth. 2024 Dec;45(6):447-459. doi: 10.1007/s11017-024-09682-2. Epub 2024 Sep 11.
4
Xenograft recipients and the right to withdraw from a clinical trial.异体移植受者与退出临床试验的权利。
Bioethics. 2024 May;38(4):308-315. doi: 10.1111/bioe.13262. Epub 2024 Jan 6.
5
Update on the ethical, legal and technical challenges of translating xenotransplantation.关于异种移植的伦理、法律和技术挑战的最新进展。
J Med Ethics. 2024 Aug 21;50(9):585-591. doi: 10.1136/jme-2023-109298.
6
Xenotransplantation Clinical Trials and Equitable Patient Selection.
Camb Q Healthc Ethics. 2024 Jul;33(3):425-434. doi: 10.1017/S096318012300052X. Epub 2023 Oct 5.
7
Revisiting the Use of Ulysses Contracts in Xenotransplantation.重新审视尤利西斯契约在异种移植中的应用。
Transplantation. 2024 Feb 1;108(2):369-373. doi: 10.1097/TP.0000000000004679. Epub 2023 May 29.
8
American Society of Transplant Surgeons-American Society of Transplantation report of FDA meeting on regulatory expectations for xenotransplantation products.美国移植外科学会-美国移植学会关于 FDA 会议对异种移植产品监管期望的报告。
Am J Transplant. 2023 Sep;23(9):1290-1299. doi: 10.1016/j.ajt.2023.05.010. Epub 2023 May 20.
9
Reevaluating the Ethical Issues in Porcine-to-Human Heart Xenotransplantation.重新评估猪心异种移植中的伦理问题。
Hastings Cent Rep. 2022 Sep;52(5):32-42. doi: 10.1002/hast.1419.
10
Informed Consent for Potential Recipients of Pig Kidney Xenotransplantation in the United States.美国猪肾异种移植潜在受者的知情同意书。
Transplantation. 2022 Sep 1;106(9):1754-1762. doi: 10.1097/TP.0000000000004144. Epub 2022 Apr 27.