Evidence mapPaperPMID 42548012Full record

ReviewXenotransplantation

Global Consultation for Clinical Xenotransplantation: International Xenotransplantation Association Consensus and Communiqué Update.

Wayne J Hawthorne, Eckhard Wolf, Peter J Cowan, Wei Wang, Ik Jin Yun, Paolo Brenner, Greg Korbutt, Raphael P H Meier, Megan Sykes, Léo H Bühler and 16 more

Abstract readConsensus StatementReview
In one paragraph

Review in Xenotransplantation. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors.

Wayne J HawthorneDepartment of Surgery, Westmead Hospital, Westmead Institute for Medical Research, Faculty of Medicine and Health, University of Sydney, Westmead, NSW, Australia.ORCID https://orcid.org/0000-0001-8638-3468
Eckhard WolfGene Center, Ludwig Maximilian University of Munich (LMU), Munich, Germany.ORCID https://orcid.org/0000-0002-0430-9510
Peter J CowanImmunology Research Centre, St Vincent's Hospital, University of Melbourne, Melbourne, Australia.
Wei WangEngineering Center for Xenotransplantation, The Third Xiangya Hospital, Central-South University, Changsha, China.
Ik Jin YunDepartment of Surgery, Konkuk University Hospital, Konkuk University, Seoul, South-Korea.ORCID https://orcid.org/0000-0003-4013-6714
Paolo BrennerDepartment of Cardiac Surgery, Klinikum Großhadern, Ludwig Maximilian University of Munich (LMU), Munich, Germany.
Greg KorbuttDepartment of Surgery, University of Alberta, Edmonton, AB, Canada.ORCID https://orcid.org/0000-0001-9690-4351
Raphael P H MeierDepartment of Surgery, University of Maryland School of Medicine, Baltimore, Maryland, USA.ORCID https://orcid.org/0000-0001-9050-0436
Megan SykesColumbia Center for Translational Immunology, Columbia University College of Physicians and Surgeons, Columbia University, New York, New York, USA.
Léo H BühlerCantonal Hospital Fribourg, Faculty of Science and Medicine, University of Fribourg, Fribourg, Switzerland.
Linda ScobieDepartment of Biological and Biomedical Sciences, School of Health and Life Sciences, Glasgow Caledonian University, Glasgow, Scotland, UK.ORCID https://orcid.org/0000-0002-0727-7163
Olga GarkavenkoNZeno Limited, Auckland, New Zealand.
Hyunil KimOptipharm, Inc., Cheongju, South Korea.
Daniel J HurstDepartment of Medical Education & Scholarship, Rowan-Virtua School of Osteopathic Medicine, Stratford, New Jersey, USA.ORCID https://orcid.org/0000-0003-0592-2592
Richard N Pierson IiiDivision of Cardiac Surgery and Center for Transplantation Sciences, Department of Surgery, Massachusetts General Hospital, Boston, Massachusetts, USA.ORCID https://orcid.org/0000-0003-3764-4590
Robert RiebenDepartment For BioMedical Research (DBMR), University of Bern, Bern, Switzerland.ORCID https://orcid.org/0000-0003-4179-8891
Manuel PascualTransplantation Center, Department of Surgery, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Nicole Scholes-RobertsonSydney School of Public Health, Faculty of Medicine and Health, University of Sydney, Westmead, NSW, Australia.
Emanuele CozziTransplant Immunology Unit, Padua University Hospital, Padua, Italy.ORCID https://orcid.org/0000-0001-7855-5055
Adrián AbalovichEva Perón Hospital of San Martin, Buenos Aires, Argentina.
Alexandre LoupyDepartment of Kidney Transplantation, Assistance Publique - Hôpitaux de Paris, Université Paris Cité, Paris Institute for Transplantation and Organ Regeneration, Paris, France.
Hidetaka HaraThe Transplantation Institute of the Second Affiliated Hospital, Hainan Medical University, Hainan, China.
Rita BottinoImagine Islet Center, Imagine Pharma, Pittsburgh, Pennsylvania, USA.ORCID https://orcid.org/0000-0003-1540-2996
Burcin EkserDivision of Intraabdominal Transplant, Department of Surgery, Stritch School of Medicine, Loyola University Medical Center, Loyola University Chicago, Maywood, Illinois, USA.
Muhammad M MohiuddinDepartment of Surgery, Cardiac Xenotransplantation Program, University of Maryland School of Medicine, Baltimore, Maryland, USA.ORCID https://orcid.org/0000-0003-4654-783X
Jay FishmanHarvard Medical School, Transplant Infectious Disease and Compromised Host Program and Transplant Center, Massachusetts General Hospital, Boston, Massachusetts, USA.ORCID https://orcid.org/0000-0002-2671-3311

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Xenotransplantation has entered a phase of accelerated clinical translation, necessitating renewed international consensus on governance, ethics, safety, and regulatory oversight. In September 2025, the International Xenotransplantation Association (IXA), in partnership with The Transplantation Society (TTS) and with engagement from the World Health Organization (WHO), convened a Global Consultation in Geneva to review, update, and harmonise international guidance for clinical xenotransplantation. This IXA consultation marked the twentieth anniversary of the first WHO Xenotransplantation Advisory Consultation in 2005 and built upon the foundational principles established through the Changsha Communiqué (2008, 2011 and 2018) and subsequent IXA and WHO-led initiatives. Responding to rapid scientific advances, including some defined donor genetic standards, improved immunosuppression, enhanced biosecurity, and strengthened infectious disease surveillance, the IXA undertook an 18‑month, structured, evidence‑based revision process. Seven expert working groups, comprising approximately forty internationally recognised specialists from fourteen countries, reviewed developments across source animal standards and biosecurity, clinical trial design and oversight, immunosuppression and patient management, infectious disease risk and surveillance, ethical and legal frameworks, international governance, and emerging technologies. Draft recommendations were further refined through iterative consultation and plenary deliberation at the in‑person meeting held in Geneva, September 2025. The consultation proposed updated Principles and Recommendations directed to WHO, national regulators, investigators and sponsors, and the IXA/TTS communities. Key elements include proportionate risk benefit assessments, robust donor and recipient surveillance, long‑term biobanking and monitoring, transparency and public engagement, harmonised regulatory oversight consistent with existing allotransplantation frameworks, and equitable access to future clinical applications. The revised guidance aligns with contemporary regulatory expectations of major international jurisdictions regulatory authorities including (AEMPS, ANMAT, CONABIA, CONFEPRIS, EMA, FDA, GTAC, HC, IEC, INCUCAI, Medsafe, MFDS, MHRA, MHLW, NMPA, NZGTAC, MFDS, MHRA, TGA); and consolidates international consensus at a critical juncture for the field. This IXA Global Consultation provides an authoritative, forward‑looking framework to support safe, ethical, and globally coordinated clinical xenotransplantation as it transitions from experimental innovation to regulated clinical practice.

Indexed as

HeterograftsTransplantation, HeterologousAnimalsHumansInternational CooperationWorld Health OrganizationChangsha Communiquéequityethical oversightglobal governanceinternational guidelineslegislationlong‐term surveillanceregulatory frameworkstransplantationWorld Health Organization (WHO)xenotransplantation

Identifiers

PMID42548012
PMCPMC13433974

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.