ThirdWHOGlobal Consultation on Regulatory Requirements for Xenotransplantation Clinical Trials, Changsha, Hunan, China December 12–14, 2018

Author:

Hawthorne Wayne J.1,Cowan Peter J.2,Bühler Léo H.3,Yi Shounan45,Bottino Rita6,Pierson Richard N.7,Ahn Curie8,Azimzadeh Agnes7,Cozzi Emanuele9,Gianello Pierre10,Lakey Jonathan R. T.11,Luo Minhua12,Miyagawa Shuji13,Mohiuddin Muhammad M.14,Park Chung‐Gyu151617,Schuurman Henk‐Jan18,Scobie Linda19,Sykes Megan20,Tector Joseph21,Tönjes Ralf Reinhard22,Wolf Eckhard23,Nuñez José R.24,Wang Wei25

Affiliation:

1. Department of SurgeryWestmead HospitalCentre for Transplant and Renal ResearchWestmead Institute for Medical ResearchSydney Medical SchoolUniversity of Sydney Westmead New South Wales Australia

2. Immunology Research CentreSt Vincent's Hospital Melbourne Victoria Australia

3. University Hospitals Geneva Geneva Switzerland

4. Center for Transplant and Renal ResearchWestmead Institute for Medical ResearchUniversity of Sydney Sydney New South Wales Australia

5. Transplantation and Gene Therapy InstituteThird Xiangya Hospital of Central South University Changsha China

6. Allegheny Health Network – Carnegie Mellon University Pittsburgh Pennsylvania

7. Department of SurgeryMassachusetts General Hospital and Harvard Medical School Boston Massachusetts

8. Division of NephrologyCollege of MedicineSeoul National University Seoul South Korea

9. Transplant Immunology UnitPadua University Hospital Padua Italy

10. Université Catholique de Louvain – Health Science Sector – Laboratory of Experimental Surgery and Transplantation Brussels Belgium

11. Department of Surgery and Biomedical EngineeringClinical Islet ProgramUniversity of California Irvine California

12. State Key Laboratory of VirologyWuhan Institute of VirologyChinese Academy of Sciences Wuhan China

13. Division of Organ TransplantationDepartment of SurgeryOsaka University Osaka Japan

14. Cardiac Xenotransplantation ProgramUniversity of Maryland School of Medicine Baltimore Maryland

15. Department of Microbiology and ImmunologySeoul National University College of Medicine Seoul South Korea

16. Department of Biomedical SciencesSeoul National University Graduate School Seoul South Korea

17. Xenotransplantation Research Center Seoul South Korea

18. SchuBiomed Consultancy Utrecht The Netherlands

19. Department of Biological and Biomedical SciencesSchool of Health and Life Sciences, GlasgowCaledonian University Glasgow UK

20. Columbia Center for Translational ImmunologyDepartment of MedicineColumbia University and Columbia University Medical Center New York New York

21. University of Alabama Birmingham School of Medicine Birmingham Alabama

22. Paul‐Ehrlich‐InstitutFederal Institute for Vaccines and BiomedicinesDivision of Medical Biotechnology Section 6/4Non‐vital Tissue Preparations and Xenogeneic Cell‐Therapeutics Langen Germany

23. Gene CenterLudwig Maximilian University of Munich Munich Germany

24. World Health Organization Geneva Switzerland

25. Cell Transplantation and Gene Therapy InstituteThird Xiangya Hospital of Central South University Changsha China

Publisher

Wiley

Subject

Transplantation,Immunology

Reference7 articles.

1. World Health Organization Department of Communicable Disease Surveillance and Response.WHO Guidance on xenogeneic infection/disease surveillance and response: a strategy for international cooperation and coordination. Document WHO/CDS/CSR/EPH/2001.2 2001.http://whqlibdoc.who.int/hq/2001/WHO_CDS_CSR_EPH_2001.2.pdf. Accessed January 1 2019.

2. World Health Organization.Fifty‐seventh World Health Assembly Agenda Item 12.14 May 22 2004. Resolution 57.18.http://www.who.int/gb/ebwha/pdf_files/WHA57/A57_R18-en.pdf. Accessed January 1 2019.

3. Position Paper of the Ethics Committee of the International Xenotransplantation Association

4. World Health Organization.Statement from the Xenotransplantation Advisory Consultation Geneva 18‐20 April 2005.https://www.who.int/transplantation/XenoEnglish.pdf. Accessed January 1 2019.

5. World Health Organization.First WHO global consultation on regulatory requirements for xenotransplantation clinical trials.Changsha:The Changsha Communiqué.2008.http://www.who.int/transplantation/xeno/ChangshaCommunique.pdf. Accessed January 1 2019. See also Xenotransplantation 2008;16:61‐63.

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