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Clinical xenotransplantation seems close: Ethical issues persist

dc.contributor.authorEntwistle, John W.
dc.contributor.authorSade, Robert M.
dc.contributor.authorDrake, Daniel H.
dc.date.accessioned2022-06-01T20:29:14Z
dc.date.available2023-07-01 16:29:13en
dc.date.available2022-06-01T20:29:14Z
dc.date.issued2022-06
dc.identifier.citationEntwistle, John W.; Sade, Robert M.; Drake, Daniel H. (2022). "Clinical xenotransplantation seems close: Ethical issues persist." Artificial Organs (6): 987-994.
dc.identifier.issn0160-564X
dc.identifier.issn1525-1594
dc.identifier.urihttps://hdl.handle.net/2027.42/172816
dc.description.abstractScientific barriers that have prevented successful xenotransplantation are being breached, yet many ethical issues remain. Some are broad issues that accompany the adoption of novel and expensive technologies, and some are unique to xenotransplantation. Major ethical questions include areas such as: viral transmission; zoonoses and lifetime surveillance; interfering with nature; efficacy, access, and expense; treatment of animals; regulation and oversight.Xenotransplantation requiring genetic modification of the donor DNA.
dc.publisherWHO
dc.publisherWiley Periodicals, Inc.
dc.subject.otherxenotransplantation
dc.subject.otherethics
dc.subject.otherheart failure
dc.titleClinical xenotransplantation seems close: Ethical issues persist
dc.typeArticle
dc.rights.robotsIndexNoFollow
dc.subject.hlbsecondlevelMedicine (General)
dc.subject.hlbtoplevelHealth Sciences
dc.description.peerreviewedPeer Reviewed
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/172816/1/aor14255.pdf
dc.description.bitstreamurlhttp://deepblue.lib.umich.edu/bitstream/2027.42/172816/2/aor14255_am.pdf
dc.identifier.doi10.1111/aor.14255
dc.identifier.sourceArtificial Organs
dc.identifier.citedreferenceOrmandy EH, Dale J, Griffin G. Genetic engineering of animals: ethical issues, including welfare concerns. Can Vet J. 2011 May; 52 ( 5 ): 544 – 50.
dc.identifier.citedreferenceRollin BE. Ethical and societal issues occasioned by xenotransplantation. Animals (Basel). 2020 Sep 19; 10 ( 9 ): 1695 – 704.
dc.identifier.citedreferenceReichart B, Längin M, Radan J, Mokelke M, Buttgereit I, Ying J, et al. Pig-to-non-human primate heart transplantation: the final step toward clinical xenotransplantation? J Heart Lung Transplant. 2020 Aug; 39 ( 8 ): 751 – 7.
dc.identifier.citedreferenceWayda B, Clemons A, Givens RC, Takeda K, Takayama H, Latif F, et al. Socioeconomic disparities in adherence and outcomes after heart transplant: a UNOS (united network for organ sharing) registry analysis. Circ Heart Fail. 2018 Mar; 11 ( 3 ): e004173.
dc.identifier.citedreferenceZhang Y, Flory JH, Bao Y. Chronic medication nonadherence and potentially preventable healthcare utilization and spending among Medicare patients. J Gen Intern Med. 2022 Jan 11. Epub ahead of print.
dc.identifier.citedreferenceFischer MA, Choudhry NK, Brill G, Avorn J, Schneeweiss S, Hutchins D, et al. Trouble getting started: predictors of primary medication nonadherence. Am J Med. 2011 Nov; 124 ( (11) ): 1081.e9-22.
dc.identifier.citedreferenceHall GL, Heath M. Poor medication adherence in African Americans is a matter of trust. J Racial Ethn Health Disparities. 2021 Aug; 8 ( 4 ): 927 – 42.
dc.identifier.citedreferenceChan JL, Mohiuddin MM. Heart xenotransplantation. Curr Opin Organ Transplant. 2017 Dec; 22 ( 6 ): 549 – 54.
dc.identifier.citedreferenceDennis JU. Morally relevant differences between animals and human beings justifying the use of animals in biomedical research. J Am Vet Med Assoc. 1997 Mar 1; 210 ( 5 ): 612 – 8.
dc.identifier.citedreferenceHussain G. How many animals are killed for food every day? Sentient Media. Available from: https://sentientmedia.org/how-many-animals-are-killed-for-food-every-day/. Accessed 21 Feb 2022.
dc.identifier.citedreferenceFishman JA. Prevention of infection in xenotransplantation: designated pathogen-free swine in the safety equation. Xenotransplantation. 2020 May; 27 ( 3 ): e12595.
dc.identifier.citedreferenceCooper DK. Clinical trials of xenotransplantation: the need for a worldwide registry. Xenotransplantation. 2020 May; 27 ( 3 ): e12598.
dc.identifier.citedreferenceKwisda K, Cantz T, Hoppe N. Regulatory and intellectual property conundrums surrounding xenotransplantation. Nat Biotechnol. 2021 Jul; 39 ( 7 ): 796 – 8.
dc.identifier.citedreferenceMarks P, Solomon S. Clarifying US regulations on xenotransplantation. Nat Biotechnol. 2021 Dec; 39 ( (12) ): 1500 – 1.
dc.identifier.citedreferenceWorld Health Organization. Fifty-seventh world health assembly. Resolutions and decisions, annexes—document WHA57/2004/REC/1. WHO; 2004.
dc.identifier.citedreferenceWorld Health Organization. First WHO global consultation on regulatory requirements for xenotransplantation clinical trials, Changsha, China; 2008 November. p. 19 – 21 (WHO, 2008).
dc.identifier.citedreferenceWorld Health Organization. Second WHO global consultation on regulatory requirements for xenotransplantation clinical trials, 2011 October 17–19. WHO, Geneva, Switzerland WHO, 2011.
dc.identifier.citedreferenceRaposo VL. The first Chinese edited babies: a leap of faith in science. JBRA Assist Reprod. 2019 Aug 22; 23 ( 3 ): 197 – 9.
dc.identifier.citedreferenceNovella SA. Breakthrough heart xenotransplantation from pig. Science-based Medicine. Available from: https://sciencebasedmedicine.org/breakthrough-heart-xenotransplantion-from-pig/. Accessed 28 Feb 2022.
dc.identifier.citedreferenceWhen will xenotransplantation of pig organs be possible? Nanalyze. Available from: https://www.nanalyze.com/2021/03/when-xenotransplantation-pig-organs-possible/. Accessed 28 Feb 2022.
dc.identifier.citedreferenceEntwistle JW, Drake DH, Fenton KN, Smith MA, Sade RM. Normothermic regional perfusion: ethical issues in thoracic organ donation. J Thorac Cardiovasc Surg. 2022: S0022-5223(22)00088-5. https://doi.org/10.1016/j.jtcvs.2022.01.018
dc.identifier.citedreferenceSmith M, Dominguez-Gil B, Greer DM, Manara AR, Souter MJ. Organ donation after circulatory death: current status and future potential. Intensive Care Med. 2019 Mar; 45 ( 3 ): 310 – 21.
dc.identifier.citedreferenceReardon S. First pig-to-human heart transplant: what can scientists learn? Nature. 2022 Jan 20; 601: 305 – 6.
dc.identifier.citedreferenceCooper DK. A brief history of cross-species organ transplantation. Proc (Bayl Univ Med Cent). 2012 Jan; 25 ( 1 ): 49 – 57.
dc.identifier.citedreferenceSade RM. A surprising Alliance: two giants of the 20th century. Ann Thorac Surg. 2017; 103: 2015 – 9.
dc.identifier.citedreferenceChoi A, Han JJ. First porcine to human kidney transplantation performed in the United States. Artif Organs. 2022 Feb; 46 ( 2 ): 178 – 9.
dc.identifier.citedreferenceKotz D. UM medicine performs historic xenotransplantation. UMB News. January 11, 2022. Available from: https://www.umaryland.edu/news/archived-news/january-2022/um-medicine-performs-historic-xenotransplantation.php#:~:text=UM%20Medicine%20Performs%20Historic%20Xenotransplantation%20January%2011%2C%202022,and%20is%20still%20doing%20well%20three%20days%20later. Accessed 14 Jan 2022.
dc.identifier.citedreferenceLopata K, Wojdas E, Nowak R, Lopata P, Mazurek U. Porcine endogenous retrovirus (PERV)—molecular structure and replication strategy in the context of retroviral infection risk of human cells. Front Microbiol. 2018 Apr 11; 9 ( 730 ): 1 – 11.
dc.identifier.citedreferenceHarrison I, Takeuchi Y, Bartosch B, Stoye JP. Determinants of high titer in recombinant porcine endogenous retroviruses. J Virol. 2004 Dec; 78 ( 24 ): 13871 – 9.
dc.identifier.citedreferenceNiu D, Wei H-J, Lin L, George H, Wang T, Lee I-H, et al. Inactivation of porcine endogenous retrovirus in pigs using CRISPR-Cas9. Science. 2017 Sep 22; 357 ( 6357 ): 1303 – 7.
dc.identifier.citedreferenceDenner J. Why was PERV not transmitted during preclinical and clinical xenotransplantation trials and after inoculation of animals? Retrovirology. 2018 Apr 2; 15 ( 1 ): 28 – 36.
dc.identifier.citedreferenceDenner J. Porcine endogenous retroviruses and xenotransplantation. Viruses. 2021 Oct 26; 13 ( 11 ): 2156 – 72.
dc.identifier.citedreferenceGüell M, Niu D, Kan Y, George H, Wang T, Lee IH, et al. PERV inactivation is necessary to guarantee absence of pig-to-patient PERVs transmission in xenotransplantation. Xenotransplantation. 2017 Nov; 24 ( 6 ): e12366.
dc.identifier.citedreferenceCaliebe A, Nebel A, Makarewicz C, Krawczak M, Krause-Kyora B. Insights into early pig domestication provided by ancient DNA analysis. Sci Rep. 2017 Mar 16; 7: 44550.
dc.identifier.citedreferenceWynyard S. Challenges and practical realities of long-term patient follow-up in three xeno-islet clinical trials: the experience in pig islet xenotransplantation trials in New Zealand and Argentina. Xenotransplantation. 2020 May; 27 ( 3 ): e12605.
dc.identifier.citedreferenceSpillman MA, Sade RM. Clinical trials of xenotransplantation: waiver of the right to withdraw from a clinical trial should be required. J Law Med Ethics. 2007 Summer; 35 ( 2 ): 265 – 72.
dc.identifier.citedreferenceSchuurman H-J, Hoogendoorn K. Solid organ xenotransplantation at the interface between research and clinical development: regulatory aspects. Xenotransplantation. 2020 May; 27 ( 3 ): e12608.
dc.identifier.citedreferenceJacobson V. Massachusetts, 197 U.S. 11 ( 1905 ).
dc.identifier.citedreferencePrice PJ. Quarantine and liability in the context of Ebola. Public Health Rep. 2016; 131 ( 3 ): 500 – 3.
dc.identifier.citedreferenceLiptak A. Supreme court blocks Biden’s virus mandate for large employers. New York Times. January 13, 2022. Available from: https://www.nytimes.com/2022/01/13/us/politics/supreme-court-biden-vaccine-mandate.html. Accessed 26 Feb 2022.
dc.identifier.citedreferenceKwisda K, White L, Hübner D. Ethical arguments concerning human-animal chimera research: a systematic review. BMC Med Ethics. 2020 Mar 23; 21 ( 1 ): 24.
dc.identifier.citedreferenceGabel I, Moreno J. Genome editing, ethics, and politics. AMA J Ethics. 2019 Dec 1; 21 ( (12) ): E1105 – 10.
dc.identifier.citedreferenceBramstedt KA. Arguments for the ethical permissibility of transgenic xenografting. Gene Ther. 2000 Apr; 7 ( 8 ): 633 – 4.
dc.identifier.citedreferenceCengiz N, Wareham CS. Ethical considerations in xenotransplantation: a review. Curr Opin Organ Transplant. 2020 Oct; 25 ( 5 ): 483 – 8.
dc.working.doiNOen
dc.owningcollnameInterdisciplinary and Peer-Reviewed


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