Next Steps for Clinical Xenotransplantation in the United States

Ideas and Opinions31 October 2023Next Steps for Clinical Xenotransplantation in the United StatesTamar Schiff, MD, Brendan Parent, JD, Ian Dittmer, MBChB, Wayne J. Hawthorne, MD, PhD, Ivo Kwon, MD, PhD, Muhammad M. Mohiuddin, MBBS, Chun-Gyu Park, MD, PhD, Peter Stock, MD, PhD, and Richard N. Pierson III, MDTamar Schiff, MDDivision of Medical Ethics, Department of Population Health, NYU Grossman School of Medicine, New York, New York (T.S., B.P.), Brendan Parent, JDDivision of Medical Ethics, Department of Population Health, NYU Grossman School of Medicine, New York, New York (T.S., B.P.), Ian Dittmer, MBChBTe Toka Tumai–Auckland City Hospital, Auckland, New Zealand (I.D.), Wayne J. Hawthorne, MD, PhDDepartment of Surgery, School of Medical Sciences, Westmead Institute for Medical Research, University of Sydney, Westmead Hospital, Westmead, New South Wales, Australia (W.J.H.), Ivo Kwon, MD, PhDDepartment of Medical Education, College of Medicine, Ewha Womans University, Seoul, Korea (I.K.), Muhammad M. Mohiuddin, MBBSDepartment of Surgery, University of Maryland School of Medicine, Baltimore, Maryland (M.M.M.), Chun-Gyu Park, MD, PhDTransplantation Research Institute, Seoul National University College of Medicine, Seoul, Korea (C.-G.P.), Peter Stock, MD, PhDDepartment of Surgery–Transplant Services, University of California, San Francisco, School of Medicine, San Francisco, California (P.S.), and Richard N. Pierson III, MDDivision of Cardiac Surgery and Center for Transplantation Sciences, Department of Surgery, Massachusetts General Hospital, Boston, Massachusetts (R.N.P.)Author, Article, and Disclosure Informationhttps://doi.org/10.7326/M23-1823 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Clinical xenotransplantation—transplantation of tissues from nonhuman animals into humans—offers the potential to mitigate the morbidity and mortality caused by the dire shortage of human organs. Pigs are the primary xenograft source of interest because they are easy to breed and the size and function of their organs are appropriate for use in humans. Through gene editing, porcine organs have been altered to overcome major human immunologic barriers, with research focused on initial clinical application of kidneys and hearts. As interest in clinical translation of the science grows, substantial concern remains about the risk for xenozoonosis—infection of xenograft recipients with microorganisms ...References1. Hawthorne WJ. Partnership of the International Xenotransplantation Association, The Transplantation Society, and World Health Organization in the development of guidance documents and policies for xenotransplantation including the Changsha communiqué. Xenotransplantation. 2020;27:e12604. [PMID: 32449210] doi:10.1111/xen.12604 CrossrefMedlineGoogle Scholar2. Cooper DKC, Pierson RN. Milestones on the path to clinical pig organ xenotransplantation. Am J Transplant. 2023;23:326-335. [PMID: 36775767] doi:10.1016/j.ajt.2022.12.023 CrossrefMedlineGoogle Scholar3. Porrett PM, Orandi BJ, Kumar V, et al. First clinical-grade porcine kidney xenotransplant using a human decedent model. Am J Transplant. 2022;22:1037-1053. [PMID: 35049121] doi:10.1111/ajt.16930 CrossrefMedlineGoogle Scholar4. Montgomery RA, Stern JM, Lonze BE, et al. Results of two cases of pig-to-human kidney xenotransplantation. N Engl J Med. 2022;386:1889-1898. [PMID: 35584156] doi:10.1056/NEJMoa2120238 CrossrefMedlineGoogle Scholar5. Locke JE, Kumar V, Anderson D, et al. Normal graft function after pig-to-human kidney xenotransplant. JAMA Surg. 2023. [PMID: 37585176] doi:10.1001/jamasurg.2023.2774 CrossrefMedlineGoogle Scholar6. Neergaard L, Lum S. Pig kidney works a record 2 months in donated body, raising hope for animal-human transplants. AP News. 2023. Accessed at https://apnews.com/article/pig-kidney-transplant-xenotransplant-83dfb5e6d022ca72039a821cc6bc00ef on 4 October 2023. Google Scholar7. Moazami N, Stern JM, Khalil K, et al. Pig-to-human heart xenotransplantation in two recently deceased human recipients. Nat Med. 2023;29:1989-1997. [PMID: 37488288] doi:10.1038/s41591-023-02471-9 CrossrefMedlineGoogle Scholar8. Mohiuddin MM, Singh AK, Scobie L, et al. Graft dysfunction in compassionate use of genetically engineered pig-to-human cardiac xenotransplantation: a case report. Lancet. 2023;402:397-410. [PMID: 37393920] doi:10.1016/S0140-6736(23)00775-4 CrossrefMedlineGoogle Scholar9. Kotz D. UM Medicine performs 2nd historic pig heart transplant. 22 September 2023. Accessed at www.umaryland.edu/news/archived-news/september-2023/um-medicine-performs-2nd-historic-pig-heart-transplant.php on 27 September 2023. Google Scholar10. Interstate Quarantine, 42 C.F.R. § 70 (2013). Google Scholar Author, Article, and Disclosure InformationAuthors: Tamar Schiff, MD; Brendan Parent, JD; Ian Dittmer, MBChB; Wayne J. Hawthorne, MD, PhD; Ivo Kwon, MD, PhD; Muhammad M. Mohiuddin, MBBS; Chun-Gyu Park, MD, PhD; Peter Stock, MD, PhD; Richard N. PiersonIII, MDAffiliations: Division of Medical Ethics, Department of Population Health, NYU Grossman School of Medicine, New York, New York (T.S., B.P.)Te Toka Tumai–Auckland City Hospital, Auckland, New Zealand (I.D.)Department of Surgery, School of Medical Sciences, Westmead Institute for Medical Research, University of Sydney, Westmead Hospital, Westmead, New South Wales, Australia (W.J.H.)Department of Medical Education, College of Medicine, Ewha Womans University, Seoul, Korea (I.K.)Department of Surgery, University of Maryland School of Medicine, Baltimore, Maryland (M.M.M.)Transplantation Research Institute, Seoul National University College of Medicine, Seoul, Korea (C.-G.P.)Department of Surgery–Transplant Services, University of California, San Francisco, School of Medicine, San Francisco, California (P.S.)Division of Cardiac Surgery and Center for Transplantation Sciences, Department of Surgery, Massachusetts General Hospital, Boston, Massachusetts (R.N.P.)Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M23-1823.Corresponding Author: Tamar Schiff, MD, 227 East 30th Street, Suite 623, New York, NY 10016; e-mail, tamar.schiff2@nyulangone.org.Author Contributions: Conception and design: T. Schiff, B. Parent, I. Dittmer, W.J. Hawthorne, I. Kwon, M.M. Mohiuddin, R.N. Pierson.Analysis and interpretation of the data: M.M. Mohiuddin.Drafting of the article: T. Schiff, B. Parent, I. Dittmer, W.J. Hawthorne, M.M. Mohiuddin, R.N. Pierson, P. Stock.Critical revision of the article for important intellectual content: T. Schiff, I. Dittmer, I. Kwon, M.M. Mohiuddin, R.N. Pierson.Final approval of the article: T. Schiff, B. Parent, I. Dittmer, W.J. Hawthorne, I. Kwon, M.M. Mohiuddin, R.N. Pierson, C.-G. Park, P. Stock.Provision of study materials or patients: C.-G. Park.Administrative, technical, or logistic support: B. Parent, I. Dittmer, R.N. Pierson.Collection and assembly of data: M.M. Mohiuddin.This article was published at Annals.org on 31 October 2023. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetails Metrics November 2023Volume 176, Issue 11Page: 1538-1539KeywordsCadaveric renal transplantationCardiac transplantationClinical trialsFood and Drug AdministrationGeneticsHeartKidneysLongitudinal studiesPrevention, policy, and public healthRenal transplantation ePublished: 31 October 2023 Issue Published: November 2023 Copyright & PermissionsCopyright © 2023 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...