Governing new technologies that stop biological time: Preparing for prolonged biopreservation of human organs in transplantation.

Autor:	Pruett TL; Department of Surgery and Internal Medicine, University of Minnesota School of Medicine, Minneapolis, MN, USA; NSF Engineering Research Center for Advanced Technologies for Preservation of Biological Systems (ATP-Bio), Minneapolis, MN, USA. Electronic address: tlpruett@umn.edu., Wolf SM; NSF Engineering Research Center for Advanced Technologies for Preservation of Biological Systems (ATP-Bio), Minneapolis, MN, USA; University of Minnesota Law School, Minneapolis, MN, USA; Department of Medicine, University of Minnesota, Minnesota, MN, USA., McVan CC; University of Minnesota Law School, Minneapolis, MN, USA., Lyon P; University of Minnesota Law School, Minneapolis, MN, USA., Capron AM; Department of Law and Medicine, University of Southern California, Los Angeles, CA, USA., Childress JF; Dept of Religious Studies, University of Virginia, Charlottesville, VA, USA., Evans BJ; Department of Law, University of Florida, Gainesville, FL, USA., Finger EB; NSF Engineering Research Center for Advanced Technologies for Preservation of Biological Systems (ATP-Bio), Minneapolis, MN, USA; Division of Transplantation, Department of Surgery, University of Minnesota Medical School, Minnesota, MN, USA., Hyun I; Center for Life Sciences and Public Learning, Museum of Science, Boston, MA, USA; Center for Bioethics, Harvard Medical School, Boston, MA, USA., Isasi R; Department of Genetics, John P. Hussman Institute for Human Genomics, University of Miami Miller School of Medicine, Miami, FL, USA; Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine, Miami, FL, USA., Marchant GE; Center for Law, Science & Innovation, Sandra Day O'Connor College of Law, Arizona State University, Tempe, AZ, USA., Maynard AD; Department of Advanced Technology Transitions, School for the Future of Technology in Society at Arizona State University, Tempe, AZ, USA., Oye KA; Department of Political Science, Massachusetts Institute of Technology, Boston, MA, USA., Toner M; NSF Engineering Research Center for Advanced Technologies for Preservation of Biological Systems (ATP-Bio), Minneapolis, MN, USA; Department of Biomedical Engineering, Harvard Medical School, Boston, MA, USA; Center for Engineering in Medicine & Surgery, Massachusetts General Hospital, Boston, MA, USA; Department of Research, Shriners Children's Boston, Boston, MA, USA., Uygun K; NSF Engineering Research Center for Advanced Technologies for Preservation of Biological Systems (ATP-Bio), Minneapolis, MN, USA; Center for Engineering in Medicine & Surgery, Massachusetts General Hospital, Boston, MA, USA; Department of Research, Shriners Children's Boston, Boston, MA, USA; Department of Surgery (Bioengineering), Harvard Medical School, Boston, MA, USA., Bischof JC; NSF Engineering Research Center for Advanced Technologies for Preservation of Biological Systems (ATP-Bio), Minneapolis, MN, USA; Department of Mechanical and Biomedical Engineering, University of Minnesota, Minnesota, MN, USA; Institute for Engineering in Medicine, University of Minnesota, Minnesota, MN, USA.
Jazyk:	angličtina
Zdroj:	American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons [Am J Transplant] 2024 Sep 19. Date of Electronic Publication: 2024 Sep 19.
DOI:	10.1016/j.ajt.2024.09.017
Abstrakt:	Time limits on organ viability from retrieval to implantation shape the US system for human organ transplantation. Preclinical research has demonstrated that emerging biopreservation technologies can prolong organ viability, perhaps indefinitely. These technologies could transform transplantation into a scheduled procedure without geographic or time constraints, permitting organ assessment and potential preconditioning of the recipients. However, the safety and efficacy of advanced biopreservation with prolonged storage of vascularized organs followed by reanimation will require new regulatory oversight, as clinicians and transplant centers are not trained in the engineering techniques involved or equipped to assess the manipulated organs. Although the Food and Drug Administration is best situated to provide that process oversight, the agency has until now declined to oversee organ quality and has excluded vascularized organs from the oversight framework of human cells, tissues, and cellular-based and tissue-based products. Integration of advanced biopreservation technologies will require new facilities for organ preservation, storage, and reanimation plus ethical guidance on immediate organ use versus preservation, national allocation, and governance of centralized organ banks. Realization of the long-term benefit of advanced biopreservation requires anticipation of the necessary legal and ethical oversight tools and that process should begin now. Competing Interests: Declaration of competing interests The authors of this manuscript have conflicts of interest to disclose as described by the American Journal of Transplantation: J. Bischof is co-founder of Vitristor and discloses “Cryopreservation compositions and methods” pending U.S. Patent Applications 14/775,998 and 17/579,369. K. Uygun is co-founder of Organ Solutions LLC. He and M. Toner are co-founders of Sylvatica Biotech Inc. All other authors have no disclosures. (Copyright © 2024 American Society of Transplantation & American Society of Transplant Surgeons. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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