Promoting Safety, Transparency, and Quality in Xenotransplantation

Abstract

Ideas and OpinionsJuly 2022Promoting Safety, Transparency, and Quality in XenotransplantationPeter P. Reese, MD, PhD and Brendan Parent, JDPeter P. Reese, MD, PhDRenal-Electrolyte and Hypertension Division, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, and Penn Transplant Institute, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania (P.P.R.) and Brendan Parent, JDDivision of Medical Ethics, New York University Grossman School of Medicine, New York, New York (B.P.).Author, Article, and Disclosure Informationhttps://doi.org/10.7326/M22-0539 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Multiple hospitals have recently conducted experiments of transplanting genetically engineered organs from pigs into humans. Transplanting nonhuman organs into human patients, known as xenotransplantation, could bring lifesaving therapy to the multitude of patients with end-stage organ disease on transplant waitlists. Over several decades, organ transplantation has thrived and earned public trust by blending novel science with a regulatory infrastructure that promotes quality and transparency. This infrastructure does not explicitly apply to xenotransplantation. As a result, leaders and public advocates of transplantation must act to create guidelines and regulations that facilitate the transition of xenotransplantation into hospitals in a way that ...References1. Veatch RM, Ross LF. Transplantation Ethics. 2nd ed. Georgetown Univ Pr; 2015. Google Scholar2. NYU Langone Health performs second successful xenotransplantation surgery [press release]. NYU Langone Health. 13 December 2021. 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PHS Guideline on Infectious Disease Issues in Xenotransplantation. OMB Control no. 0910-0456. Current through 30 June 2022. Accessed at https://omb.report/omb/0910-0456 on 18 January 2022. Google Scholar8. Reese PP, Abt PL, Blumberg EA, et al. Twelve-month outcomes after transplant of hepatitis C–infected kidneys into uninfected recipients: a single-group trial. Ann Intern Med. 2018;169:273-81. [PMID: 30083748] doi:10.7326/M18-0749 LinkGoogle Scholar9. Glazier AK. Regulatory oversight in the United States of vascularized composite allografts. Transpl Int. 2016;29:682-5. [PMID: 26284312] doi:10.1111/tri.12657 CrossrefMedlineGoogle Scholar10. Levitsky J, Formica RN, Bloom RD, et al. The American Society of Transplantation consensus conference on the use of hepatitis C viremic donors in solid organ transplantation. Am J Transplant. 2017;17:2790-802. [PMID: 28556422] doi:10.1111/ajt.14381 CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: Renal-Electrolyte and Hypertension Division, Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, and Penn Transplant Institute, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania (P.P.R.)Division of Medical Ethics, New York University Grossman School of Medicine, New York, New York (B.P.).Financial Support: Professor Parent directs the Transplant Ethics and Policy Research Program at NYU Grossman School of Medicine, which is in part supported by an independent gift from United Therapeutics.Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M22-0539.Corresponding Author: Peter P. Reese, MD, PhD, 917 Blockley Hall, 423 Guardian Drive, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA 19104; e-mail, peter.[email protected]upenn.edu.Author Contributions: Conception and design: P.P. Reese, B. Parent.Drafting of the article: P.P. Reese, B. Parent.Critical revision of the article for important intellectual content: B. Parent.Final approval of the article: P.P. Reese, B. Parent.This article was published at Annals.org on 17 May 2022. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics Cited byEthics and the emerging use of pig organs for xenotransplantation July 2022Volume 175, Issue 7Page: 1032-1034KeywordsCardiac transplantationFood and Drug AdministrationHospital medicineKidneysOrgan transplantationPrevention, policy, and public healthRenal transplantationSolid organ transplantationTransplantation ePublished: 17 May 2022 Issue Published: July 2022 Copyright & PermissionsCopyright © 2022 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...

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