Academic Journal
Governance, regulation and public trust in xenotransplantation.
| Τίτλος: | Governance, regulation and public trust in xenotransplantation. |
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| Συγγραφείς: | Fovargue S; School of Law, University of Sheffield, Sheffield, UK. |
| Πηγή: | Current opinion in organ transplantation [Curr Opin Organ Transplant] 2026 Feb 01; Vol. 31 (1), pp. 21-26. Date of Electronic Publication: 2025 Dec 01. |
| Τύπος έκδοσης: | Review; Journal Article |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: Lippincott Williams & Wilkins Country of Publication: United States NLM ID: 9717388 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1531-7013 (Electronic) Linking ISSN: 10872418 NLM ISO Abbreviation: Curr Opin Organ Transplant Subsets: MEDLINE |
| Imprint Name(s): | Publication: <2003->: Hagerstown, MD : Lippincott Williams & Wilkins Original Publication: Philadelphia, PA : Rapid Science Publishers |
| Ιατρικοί όροι (MeSH): | Transplantation, Heterologous*/legislation & jurisprudence , Transplantation, Heterologous*/adverse effects , Trust* , Public Opinion* , Government Regulation* , Health Knowledge, Attitudes, Practice*, Informed Consent/legislation & jurisprudence ; Clinical Trials as Topic/legislation & jurisprudence ; Humans ; Animals ; United States ; International Cooperation ; United States Food and Drug Administration ; Risk Assessment |
| Περίληψη: | Purpose of Review: Across the world, several solid organ xenotransplants have been reported as being provided to deceased people and to living patients. In the United States, xenotransplants to living patients have been authorized under the Food and Drug Administration's Expanded Access program, and clinical liver and kidney xenotransplants have also been reported in China. During 2025, the first clinical trials of kidney and liver xenotransplants have been approved in the United States. These developments make it necessary to understand the regulatory and governance issues and challenges raised by clinical xenotransplants. Recent Findings: Key regulatory and governance issues remain to be addressed before xenotransplant clinical trials begin, including identifying the responsible regulator, drafting informed consent protocols, and establishing long-term monitoring regimens. International cooperation and collaboration are key to establishing appropriate and effective regulatory regimes and frameworks which enable science to proceed while offering the necessary protections to those involved. Public awareness, education and trust are central to the success of clinical xenotransplantation. Summary: Starting xenotransplant clinical trials too soon and without appropriate regulation and governance, may affect public trust in this biotechnology specifically and science more generally. The possible risks of xenotransplantation necessitate exploration of global harmonization and regulatory frameworks for clinical xenotransplantation. (Copyright © 2025 Wolters Kluwer Health, Inc. All rights reserved.) |
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| Contributed Indexing: | Keywords: clinical xenotransplantation; governance; law; public trust; regulation |
| Entry Date(s): | Date Created: 20260102 Date Completed: 20260102 Latest Revision: 20260102 |
| Update Code: | 20260130 |
| DOI: | 10.1097/MOT.0000000000001257 |
| PMID: | 41479220 |
| Βάση Δεδομένων: | MEDLINE |
| ISSN: | 1531-7013 |
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| DOI: | 10.1097/MOT.0000000000001257 |