The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of xenocorneal transplantation
Identifieur interne : 001273 ( Istex/Corpus ); précédent : 001272; suivant : 001274The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of xenocorneal transplantation
Auteurs : Mee Kum Kim ; Hyuk Jin Choi ; Ivo Kwon ; Richard N. Pierson Iii ; David K. C. Cooper ; Jean-Paul Soulillou ; Philip J. O'Connell ; Bertrand Vabres ; Naoyuki Maeda ; Hidetaka Hara ; Linda Scobie ; Pierre Gianello ; Yasuhiro Takeuchi ; Kazuhiko Yamada ; Eung-Soo Hwang ; Sang Joon Kim ; Chung-Gyu ParkSource :
- Xenotransplantation [ 0908-665X ] ; 2014-09.
Abstract
To develop an international consensus regarding the appropriate conditions for undertaking clinical trials in xenocorneal transplantation, here we review specific ethical, logistical, scientific, and regulatory issues regarding xenocorneal transplantation, and propose guidelines for conduct of clinical xenocorneal transplantation trials. These proposed guidelines are modeled on the published consensus statement of the International Xenotransplantation Association regarding recommended guidelines for conduct of clinical islet xenotransplantation. It is expected that this initial consensus statement will be revised over time in response to scientific advances in the field, and changes in the regulatory framework based on accumulating clinical experience.
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DOI: 10.1111/xen.12129
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UK</mods:affiliation></affiliation></author><author><name sortKey="Yamada, Kazuhiko" sort="Yamada, Kazuhiko" uniqKey="Yamada K" first="Kazuhiko" last="Yamada">Kazuhiko Yamada</name><affiliation><mods:affiliation>Transplantation Biology Research Center, Massachusetts General Hospital, Harvard Medical School, MA, Boston, USA</mods:affiliation></affiliation></author><author><name sortKey="Hwang, Eung Oo" sort="Hwang, Eung Oo" uniqKey="Hwang E" first="Eung-Soo" last="Hwang">Eung-Soo Hwang</name><affiliation><mods:affiliation>Xenotransplantation Research Center, Seoul National University College Of Medicine and Clinical Research Institute, Seoul National University Hospital, Seoul, Korea</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Microbiology and Immunology, Seoul National University College of Medicine, Seoul, Korea</mods:affiliation></affiliation></author><author><name sortKey="Kim, Sang Joon" sort="Kim, Sang Joon" uniqKey="Kim S" first="Sang Joon" last="Kim">Sang Joon Kim</name><affiliation><mods:affiliation>Organ Transplantation Center, Myong‐Ji Hospital, Goyang‐city, Korea</mods:affiliation></affiliation></author><author><name sortKey="Park, Chung Yu" sort="Park, Chung Yu" uniqKey="Park C" first="Chung-Gyu" last="Park">Chung-Gyu Park</name><affiliation><mods:affiliation>Xenotransplantation Research Center, Seoul National University College Of Medicine and Clinical Research Institute, Seoul National University Hospital, Seoul, Korea</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Microbiology and Immunology, Seoul National University College of Medicine, Seoul, Korea</mods:affiliation></affiliation><affiliation><mods:affiliation>E-mail: chgpark@snu.ac.kr</mods:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:4CFB1A3973FF6CDF4D4D1F2163273D43FBB202BC</idno><date when="2014" year="2014">2014</date><idno type="doi">10.1111/xen.12129</idno><idno type="url">https://api.istex.fr/document/4CFB1A3973FF6CDF4D4D1F2163273D43FBB202BC/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">001273</idno><idno type="wicri:explorRef" wicri:stream="Istex" wicri:step="Corpus" wicri:corpus="ISTEX">001273</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main">The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of xenocorneal transplantation</title><author><name sortKey="Kim, Mee Kum" sort="Kim, Mee Kum" uniqKey="Kim M" first="Mee Kum" last="Kim">Mee Kum Kim</name><affiliation><mods:affiliation>Department of Ophthalmology, Seoul National University College of Medicine, Seoul, Korea</mods:affiliation></affiliation><affiliation><mods:affiliation>Laboratory of Ocular Regenerative Medicine and Immunology, Seoul Artificial Eye Center, Seoul National University Hospital Biomedical Research Institute, Seoul, Korea</mods:affiliation></affiliation><affiliation><mods:affiliation>Xenotransplantation Research Center, Seoul National University College Of Medicine and Clinical Research Institute, Seoul National University Hospital, Seoul, Korea</mods:affiliation></affiliation></author><author><name sortKey="Choi, Hyuk Jin" sort="Choi, Hyuk Jin" uniqKey="Choi H" first="Hyuk Jin" last="Choi">Hyuk Jin Choi</name><affiliation><mods:affiliation>Department of Ophthalmology, Seoul National University College of Medicine, Seoul, Korea</mods:affiliation></affiliation><affiliation><mods:affiliation>Laboratory of Ocular Regenerative Medicine and Immunology, Seoul Artificial Eye Center, Seoul National University Hospital Biomedical Research Institute, Seoul, Korea</mods:affiliation></affiliation><affiliation><mods:affiliation>Xenotransplantation Research Center, Seoul National University College Of Medicine and Clinical Research Institute, Seoul National University Hospital, Seoul, Korea</mods:affiliation></affiliation></author><author><name sortKey="Kwon, Ivo" sort="Kwon, Ivo" uniqKey="Kwon I" first="Ivo" last="Kwon">Ivo Kwon</name><affiliation><mods:affiliation>Xenotransplantation Research Center, Seoul National University College Of Medicine and Clinical Research Institute, Seoul National University Hospital, Seoul, Korea</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Medical Education, School of Medicine, Ewha Womans University, Seoul, Korea</mods:affiliation></affiliation></author><author><name sortKey="Pierson Iii, Richard N" sort="Pierson Iii, Richard N" uniqKey="Pierson Iii R" first="Richard N." last="Pierson Iii">Richard N. Pierson Iii</name><affiliation><mods:affiliation>Department of Surgery, University of Maryland Medical Center, MD, Baltimore, USA</mods:affiliation></affiliation></author><author><name sortKey="Cooper, David K C" sort="Cooper, David K C" uniqKey="Cooper D" first="David K. C." last="Cooper">David K. C. Cooper</name><affiliation><mods:affiliation>Department of Surgery, Thomas E. Starzl Transplantation Institute, PA, Pittsburgh, USA</mods:affiliation></affiliation></author><author><name sortKey="Soulillou, Jean Aul" sort="Soulillou, Jean Aul" uniqKey="Soulillou J" first="Jean-Paul" last="Soulillou">Jean-Paul Soulillou</name><affiliation><mods:affiliation>Faculté de Médecine, Université de Nantes, Nantes, France</mods:affiliation></affiliation></author><author><name sortKey="O Connell, Philip J" sort="O Connell, Philip J" uniqKey="O Connell P" first="Philip J." last="O'Connell">Philip J. O'Connell</name><affiliation><mods:affiliation>Centre for Transplant and Renal Research, Westmead Millennium Institute, Westmead Hospital, NSW, Westmead, Australia</mods:affiliation></affiliation></author><author><name sortKey="Vabres, Bertrand" sort="Vabres, Bertrand" uniqKey="Vabres B" first="Bertrand" last="Vabres">Bertrand Vabres</name><affiliation><mods:affiliation>Service d'Ophtalmologie, CHU Nantes, Nantes, France</mods:affiliation></affiliation></author><author><name sortKey="Maeda, Naoyuki" sort="Maeda, Naoyuki" uniqKey="Maeda N" first="Naoyuki" last="Maeda">Naoyuki Maeda</name><affiliation><mods:affiliation>Department of Ophthalmology, Osaka University Medical School, Osaka, Japan</mods:affiliation></affiliation></author><author><name sortKey="Hara, Hidetaka" sort="Hara, Hidetaka" uniqKey="Hara H" first="Hidetaka" last="Hara">Hidetaka Hara</name><affiliation><mods:affiliation>Thomas E. Starzl Transplantation Institute, University of Pittsburgh, PA, Pittsburgh, USA</mods:affiliation></affiliation></author><author><name sortKey="Scobie, Linda" sort="Scobie, Linda" uniqKey="Scobie L" first="Linda" last="Scobie">Linda Scobie</name><affiliation><mods:affiliation>Department of Life Sciences, Glasgow Caledonian University, Glasgow, UK</mods:affiliation></affiliation></author><author><name sortKey="Gianello, Pierre" sort="Gianello, Pierre" uniqKey="Gianello P" first="Pierre" last="Gianello">Pierre Gianello</name><affiliation><mods:affiliation>Universite catholique de Louvain, Brussels, Belgium</mods:affiliation></affiliation></author><author><name sortKey="Takeuchi, Yasuhiro" sort="Takeuchi, Yasuhiro" uniqKey="Takeuchi Y" first="Yasuhiro" last="Takeuchi">Yasuhiro Takeuchi</name><affiliation><mods:affiliation>MRC/UCL Centre for Medical Molecular Virology and Wohl Virion Centre, Division of Infection & Immunity, University College London, London, UK</mods:affiliation></affiliation></author><author><name sortKey="Yamada, Kazuhiko" sort="Yamada, Kazuhiko" uniqKey="Yamada K" first="Kazuhiko" last="Yamada">Kazuhiko Yamada</name><affiliation><mods:affiliation>Transplantation Biology Research Center, Massachusetts General Hospital, Harvard Medical School, MA, Boston, USA</mods:affiliation></affiliation></author><author><name sortKey="Hwang, Eung Oo" sort="Hwang, Eung Oo" uniqKey="Hwang E" first="Eung-Soo" last="Hwang">Eung-Soo Hwang</name><affiliation><mods:affiliation>Xenotransplantation Research Center, Seoul National University College Of Medicine and Clinical Research Institute, Seoul National University Hospital, Seoul, Korea</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Microbiology and Immunology, Seoul National University College of Medicine, Seoul, Korea</mods:affiliation></affiliation></author><author><name sortKey="Kim, Sang Joon" sort="Kim, Sang Joon" uniqKey="Kim S" first="Sang Joon" last="Kim">Sang Joon Kim</name><affiliation><mods:affiliation>Organ Transplantation Center, Myong‐Ji Hospital, Goyang‐city, Korea</mods:affiliation></affiliation></author><author><name sortKey="Park, Chung Yu" sort="Park, Chung Yu" uniqKey="Park C" first="Chung-Gyu" last="Park">Chung-Gyu Park</name><affiliation><mods:affiliation>Xenotransplantation Research Center, Seoul National University College Of Medicine and Clinical Research Institute, Seoul National University Hospital, Seoul, Korea</mods:affiliation></affiliation><affiliation><mods:affiliation>Department of Microbiology and Immunology, Seoul National University College of Medicine, Seoul, Korea</mods:affiliation></affiliation><affiliation><mods:affiliation>E-mail: chgpark@snu.ac.kr</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j" type="main">Xenotransplantation</title><title level="j" type="alt">XENOTRANSPLANTATION</title><idno type="ISSN">0908-665X</idno><idno type="eISSN">1399-3089</idno><imprint><biblScope unit="vol">21</biblScope><biblScope unit="issue">5</biblScope><biblScope unit="page" from="420">420</biblScope><biblScope unit="page" to="430">430</biblScope><biblScope unit="page-count">11</biblScope><date type="published" when="2014-09">2014-09</date></imprint><idno type="ISSN">0908-665X</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0908-665X</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract">To develop an international consensus regarding the appropriate conditions for undertaking clinical trials in xenocorneal transplantation, here we review specific ethical, logistical, scientific, and regulatory issues regarding xenocorneal transplantation, and propose guidelines for conduct of clinical xenocorneal transplantation trials. These proposed guidelines are modeled on the published consensus statement of the International Xenotransplantation Association regarding recommended guidelines for conduct of clinical islet xenotransplantation. It is expected that this initial consensus statement will be revised over time in response to scientific advances in the field, and changes in the regulatory framework based on accumulating clinical experience.</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>Mee Kum Kim</name><affiliations><json:string>Department of Ophthalmology, Seoul National University College of Medicine, Seoul, Korea</json:string><json:string>Laboratory of Ocular Regenerative Medicine and Immunology, Seoul Artificial Eye Center, Seoul National University Hospital Biomedical Research Institute, Seoul, Korea</json:string><json:string>Xenotransplantation Research Center, Seoul National University College Of Medicine and Clinical Research Institute, Seoul National University Hospital, Seoul, Korea</json:string></affiliations></json:item><json:item><name>Hyuk Jin Choi</name><affiliations><json:string>Department of Ophthalmology, Seoul National University College of Medicine, Seoul, Korea</json:string><json:string>Laboratory of Ocular Regenerative Medicine and Immunology, Seoul Artificial Eye Center, Seoul National University Hospital Biomedical Research Institute, Seoul, Korea</json:string><json:string>Xenotransplantation Research Center, Seoul National University College Of Medicine and Clinical Research Institute, Seoul National University Hospital, Seoul, Korea</json:string></affiliations></json:item><json:item><name>Ivo Kwon</name><affiliations><json:string>Xenotransplantation Research Center, Seoul National University College Of Medicine and Clinical Research Institute, Seoul National University Hospital, Seoul, Korea</json:string><json:string>Department of Medical Education, School of Medicine, Ewha Womans University, Seoul, Korea</json:string></affiliations></json:item><json:item><name>Richard N. Pierson III</name><affiliations><json:string>Department of Surgery, University of Maryland Medical Center, MD, Baltimore, USA</json:string></affiliations></json:item><json:item><name>David K. C. Cooper</name><affiliations><json:string>Department of Surgery, Thomas E. Starzl Transplantation Institute, PA, Pittsburgh, USA</json:string></affiliations></json:item><json:item><name>Jean‐Paul Soulillou</name><affiliations><json:string>Faculté de Médecine, Université de Nantes, Nantes, France</json:string></affiliations></json:item><json:item><name>Philip J. O'Connell</name><affiliations><json:string>Centre for Transplant and Renal Research, Westmead Millennium Institute, Westmead Hospital, NSW, Westmead, Australia</json:string></affiliations></json:item><json:item><name>Bertrand Vabres</name><affiliations><json:string>Service d'Ophtalmologie, CHU Nantes, Nantes, France</json:string></affiliations></json:item><json:item><name>Naoyuki Maeda</name><affiliations><json:string>Department of Ophthalmology, Osaka University Medical School, Osaka, Japan</json:string></affiliations></json:item><json:item><name>Hidetaka Hara</name><affiliations><json:string>Thomas E. Starzl Transplantation Institute, University of Pittsburgh, PA, Pittsburgh, USA</json:string></affiliations></json:item><json:item><name>Linda Scobie</name><affiliations><json:string>Department of Life Sciences, Glasgow Caledonian University, Glasgow, UK</json:string></affiliations></json:item><json:item><name>Pierre Gianello</name><affiliations><json:string>Universite catholique de Louvain, Brussels, Belgium</json:string></affiliations></json:item><json:item><name>Yasuhiro Takeuchi</name><affiliations><json:string>MRC/UCL Centre for Medical Molecular Virology and Wohl Virion Centre, Division of Infection & Immunity, University College London, London, UK</json:string></affiliations></json:item><json:item><name>Kazuhiko Yamada</name><affiliations><json:string>Transplantation Biology Research Center, Massachusetts General Hospital, Harvard Medical School, MA, Boston, USA</json:string></affiliations></json:item><json:item><name>Eung‐Soo Hwang</name><affiliations><json:string>Xenotransplantation Research Center, Seoul National University College Of Medicine and Clinical Research Institute, Seoul National University Hospital, Seoul, Korea</json:string><json:string>Department of Microbiology and Immunology, Seoul National University College of Medicine, Seoul, Korea</json:string></affiliations></json:item><json:item><name>Sang Joon Kim</name><affiliations><json:string>Organ Transplantation Center, Myong‐Ji Hospital, Goyang‐city, Korea</json:string></affiliations></json:item><json:item><name>Chung‐Gyu Park</name><affiliations><json:string>Xenotransplantation Research Center, Seoul National University College Of Medicine and Clinical Research Institute, Seoul National University Hospital, Seoul, Korea</json:string><json:string>Department of Microbiology and Immunology, Seoul National University College of Medicine, Seoul, Korea</json:string><json:string>E-mail: chgpark@snu.ac.kr</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>consensus statement</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>cornea</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>ethics</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>international Guideline</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>regulation</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>xenocorneal transplantation</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>xenotransplantation</value></json:item></subject><articleId><json:string>XEN12129</json:string></articleId><arkIstex>ark:/67375/WNG-QMSCQNBJ-2</arkIstex><language><json:string>eng</json:string></language><originalGenre><json:string>reviewArticle</json:string></originalGenre><abstract>To develop an international consensus regarding the appropriate conditions for undertaking clinical trials in xenocorneal transplantation, here we review specific ethical, logistical, scientific, and regulatory issues regarding xenocorneal transplantation, and propose guidelines for conduct of clinical xenocorneal transplantation trials. These proposed guidelines are modeled on the published consensus statement of the International Xenotransplantation Association regarding recommended guidelines for conduct of clinical islet xenotransplantation. It is expected that this initial consensus statement will be revised over time in response to scientific advances in the field, and changes in the regulatory framework based on accumulating clinical experience.</abstract><qualityIndicators><score>8.14</score><pdfWordCount>6551</pdfWordCount><pdfCharCount>45473</pdfCharCount><pdfVersion>1.3</pdfVersion><pdfPageCount>11</pdfPageCount><pdfPageSize>595.276 x 782.362 pts</pdfPageSize><refBibsNative>true</refBibsNative><abstractWordCount>95</abstractWordCount><abstractCharCount>762</abstractCharCount><keywordCount>7</keywordCount></qualityIndicators><title>The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of xenocorneal transplantation</title><genre><json:string>review-article</json:string></genre><host><title>Xenotransplantation</title><language><json:string>unknown</json:string></language><doi><json:string>10.1111/(ISSN)1399-3089</json:string></doi><issn><json:string>0908-665X</json:string></issn><eissn><json:string>1399-3089</json:string></eissn><publisherId><json:string>XEN</json:string></publisherId><volume>21</volume><issue>5</issue><pages><first>420</first><last>430</last><total>11</total></pages><genre><json:string>journal</json:string></genre><subject><json:item><value>Review 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Kum</forename><surname>Kim</surname></persName><affiliation><orgName>Department of Ophthalmology</orgName><orgName>Seoul National University College of Medicine</orgName><address><settlement type="city">Seoul</settlement><country key="KP">Korea</country></address></affiliation><affiliation><orgName>Laboratory of Ocular Regenerative Medicine and Immunology</orgName><orgName>Seoul Artificial Eye Center</orgName><orgName>Seoul National University Hospital Biomedical Research Institute</orgName><address><settlement type="city">Seoul</settlement><country key="KP">Korea</country></address></affiliation><affiliation><orgName>Xenotransplantation Research Center</orgName><orgName>Seoul National University College Of Medicine and Clinical Research Institute</orgName><orgName>Seoul National University Hospital</orgName><address><settlement type="city">Seoul</settlement><country key="KP">Korea</country></address></affiliation></author><author xml:id="author-0001"><persName><forename type="first">Hyuk Jin</forename><surname>Choi</surname></persName><affiliation><orgName>Department of Ophthalmology</orgName><orgName>Seoul National University College of Medicine</orgName><address><settlement type="city">Seoul</settlement><country key="KP">Korea</country></address></affiliation><affiliation><orgName>Laboratory of Ocular Regenerative Medicine and Immunology</orgName><orgName>Seoul Artificial Eye Center</orgName><orgName>Seoul National University Hospital Biomedical Research Institute</orgName><address><settlement type="city">Seoul</settlement><country key="KP">Korea</country></address></affiliation><affiliation><orgName>Xenotransplantation Research Center</orgName><orgName>Seoul National University College Of Medicine and Clinical Research Institute</orgName><orgName>Seoul National University Hospital</orgName><address><settlement type="city">Seoul</settlement><country key="KP">Korea</country></address></affiliation></author><author xml:id="author-0002"><persName><forename type="first">Ivo</forename><surname>Kwon</surname></persName><affiliation><orgName>Xenotransplantation Research Center</orgName><orgName>Seoul National University College Of Medicine and Clinical Research Institute</orgName><orgName>Seoul National University Hospital</orgName><address><settlement type="city">Seoul</settlement><country key="KP">Korea</country></address></affiliation><affiliation><orgName>Department of Medical Education</orgName><orgName>School of Medicine</orgName><orgName>Ewha Womans University</orgName><address><settlement type="city">Seoul</settlement><country key="KP">Korea</country></address></affiliation></author><author xml:id="author-0003"><persName><genName>III</genName><forename type="first">Richard N.</forename><surname>Pierson</surname></persName><affiliation><orgName>Department of Surgery</orgName><orgName>University of Maryland Medical Center</orgName><address><settlement type="city">Baltimore</settlement><region>MD</region><country key="US">USA</country></address></affiliation></author><author xml:id="author-0004"><persName><forename type="first">David K. C.</forename><surname>Cooper</surname></persName><affiliation><orgName>Department of Surgery</orgName><orgName>Thomas E. Starzl Transplantation Institute</orgName><address><settlement type="city">Pittsburgh</settlement><region>PA</region><country key="US">USA</country></address></affiliation></author><author xml:id="author-0005"><persName><forename type="first">Jean‐Paul</forename><surname>Soulillou</surname></persName><affiliation><orgName>Faculté de Médecine</orgName><orgName>Université de Nantes</orgName><address><settlement type="city">Nantes</settlement><country key="FR">France</country></address></affiliation></author><author xml:id="author-0006"><persName><forename type="first">Philip J.</forename><surname>O'Connell</surname></persName><affiliation><orgName>Centre for Transplant and Renal Research</orgName><orgName>Westmead Millennium Institute</orgName><orgName>Westmead Hospital</orgName><address><settlement type="city">Westmead</settlement><region>NSW</region><country key="AU">Australia</country></address></affiliation></author><author xml:id="author-0007"><persName><forename type="first">Bertrand</forename><surname>Vabres</surname></persName><affiliation><orgName>Service d'Ophtalmologie</orgName><orgName>CHU Nantes</orgName><address><settlement type="city">Nantes</settlement><country key="FR">France</country></address></affiliation></author><author xml:id="author-0008"><persName><forename type="first">Naoyuki</forename><surname>Maeda</surname></persName><affiliation><orgName>Department of Ophthalmology</orgName><orgName>Osaka University Medical School</orgName><address><settlement type="city">Osaka</settlement><country key="JP">Japan</country></address></affiliation></author><author xml:id="author-0009"><persName><forename type="first">Hidetaka</forename><surname>Hara</surname></persName><affiliation><orgName>Thomas E. Starzl Transplantation Institute</orgName><orgName>University of Pittsburgh</orgName><address><settlement type="city">Pittsburgh</settlement><region>PA</region><country key="US">USA</country></address></affiliation></author><author xml:id="author-0010"><persName><forename type="first">Linda</forename><surname>Scobie</surname></persName><affiliation><orgName>Department of Life Sciences</orgName><orgName>Glasgow Caledonian University</orgName><address><settlement type="city">Glasgow</settlement><country key="GB">UK</country></address></affiliation></author><author xml:id="author-0011"><persName><forename type="first">Pierre</forename><surname>Gianello</surname></persName><affiliation><orgName>Universite catholique de Louvain</orgName><address><settlement type="city">Brussels</settlement><country key="BE">Belgium</country></address></affiliation></author><author xml:id="author-0012"><persName><forename type="first">Yasuhiro</forename><surname>Takeuchi</surname></persName><affiliation><orgName>MRC/UCL Centre for Medical Molecular Virology and Wohl Virion Centre</orgName><orgName>Division of Infection & Immunity</orgName><orgName>University College London</orgName><address><settlement type="city">London</settlement><country key="GB">UK</country></address></affiliation></author><author xml:id="author-0013"><persName><forename type="first">Kazuhiko</forename><surname>Yamada</surname></persName><affiliation><orgName>Transplantation Biology Research Center</orgName><orgName>Massachusetts General Hospital</orgName><orgName>Harvard Medical School</orgName><address><settlement type="city">Boston</settlement><region>MA</region><country key="US">USA</country></address></affiliation></author><author xml:id="author-0014"><persName><forename type="first">Eung‐Soo</forename><surname>Hwang</surname></persName><affiliation><orgName>Xenotransplantation Research Center</orgName><orgName>Seoul National University College Of Medicine and Clinical Research Institute</orgName><orgName>Seoul National University Hospital</orgName><address><settlement type="city">Seoul</settlement><country key="KP">Korea</country></address></affiliation><affiliation><orgName>Department of Microbiology and Immunology</orgName><orgName>Seoul National University College of Medicine</orgName><address><settlement type="city">Seoul</settlement><country key="KP">Korea</country></address></affiliation></author><author xml:id="author-0015"><persName><forename type="first">Sang Joon</forename><surname>Kim</surname></persName><affiliation><orgName>Organ Transplantation Center</orgName><orgName>Myong‐Ji Hospital</orgName><address><settlement type="city">Goyang‐city</settlement><country key="KP">Korea</country></address></affiliation></author><author xml:id="author-0016" role="corresp"><persName><forename type="first">Chung‐Gyu</forename><surname>Park</surname></persName><affiliation><orgName>Xenotransplantation Research Center</orgName><orgName>Seoul National University College Of Medicine and Clinical Research Institute</orgName><orgName>Seoul National University Hospital</orgName><address><settlement type="city">Seoul</settlement><country key="KP">Korea</country></address></affiliation><affiliation><orgName>Department of Microbiology and Immunology</orgName><orgName>Seoul National University College of Medicine</orgName><address><settlement type="city">Seoul</settlement><country key="KP">Korea</country></address></affiliation><affiliation>Address reprint requests to Chung‐Gyu Park, Department of Microbiology and Immunology, Department of Biomedical Sciences, Cancer Research Institute, Xenotransplantation Research Center, Seoul National University College of Medicine, 103 Daehak‐ro Jongno‐gu, 110‐799 Seoul, Korea (E‐mail: chgpark@snu.ac.kr)</affiliation></author><idno type="istex">4CFB1A3973FF6CDF4D4D1F2163273D43FBB202BC</idno><idno type="ark">ark:/67375/WNG-QMSCQNBJ-2</idno><idno type="DOI">10.1111/xen.12129</idno><idno type="unit">XEN12129</idno><idno type="toTypesetVersion">file:XEN.XEN12129.pdf</idno></analytic><monogr><title level="j" type="main">Xenotransplantation</title><title level="j" type="alt">XENOTRANSPLANTATION</title><idno type="pISSN">0908-665X</idno><idno type="eISSN">1399-3089</idno><idno type="book-DOI">10.1111/(ISSN)1399-3089</idno><idno type="book-part-DOI">10.1111/xen.2014.21.issue-5</idno><idno type="product">XEN</idno><imprint><biblScope unit="vol">21</biblScope><biblScope unit="issue">5</biblScope><biblScope unit="page" from="420">420</biblScope><biblScope unit="page" to="430">430</biblScope><biblScope unit="page-count">11</biblScope><date type="published" when="2014-09"></date></imprint></monogr></biblStruct></sourceDesc></fileDesc><profileDesc><abstract style="main" xml:id="xen12129-abs-0001"><head>Abstract</head><p>To develop an international consensus regarding the appropriate conditions for undertaking clinical trials in xenocorneal transplantation, here we review specific ethical, logistical, scientific, and regulatory issues regarding xenocorneal transplantation, and propose guidelines for conduct of clinical xenocorneal transplantation trials. These proposed guidelines are modeled on the published consensus statement of the International Xenotransplantation Association regarding recommended guidelines for conduct of clinical islet xenotransplantation. It is expected that this initial consensus statement will be revised over time in response to scientific advances in the field, and changes in the regulatory framework based on accumulating clinical experience.</p></abstract><textClass><keywords><term xml:id="xen12129-kwd-0001">consensus statement</term><term xml:id="xen12129-kwd-0002">cornea</term><term xml:id="xen12129-kwd-0003">ethics</term><term xml:id="xen12129-kwd-0004">international Guideline</term><term xml:id="xen12129-kwd-0005">regulation</term><term xml:id="xen12129-kwd-0006">xenocorneal transplantation</term><term xml:id="xen12129-kwd-0007">xenotransplantation</term></keywords><keywords rend="articleCategory"><term>Review Article</term></keywords><keywords rend="tocHeading1"><term>REVIEW ARTICLES</term></keywords></textClass><langUsage><language ident="en"></language></langUsage></profileDesc></teiHeader></istex:fulltextTEI></fulltext><metadata><istex:metadataXml wicri:clean="Wiley, elements deleted: body"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="yes"</istex:xmlDeclaration><istex:document><component type="serialArticle" version="2.0" xml:id="xen12129" xml:lang="en"><header><publicationMeta level="product"><doi origin="wiley" registered="yes">10.1111/(ISSN)1399-3089</doi><issn type="print">0908-665X</issn><issn type="electronic">1399-3089</issn><idGroup><id type="product" value="XEN"></id></idGroup><titleGroup><title sort="XENOTRANSPLANTATION" type="main">Xenotransplantation</title><title type="short">Xenotransplantation</title></titleGroup></publicationMeta><publicationMeta level="part" position="50"><doi origin="wiley">10.1111/xen.2014.21.issue-5</doi><copyright ownership="publisher">© 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.</copyright><numberingGroup><numbering type="journalVolume" number="21">21</numbering><numbering type="journalIssue">5</numbering></numberingGroup><coverDate startDate="2014-09">September/October 2014</coverDate></publicationMeta><publicationMeta level="unit" position="30" status="forIssue" type="reviewArticle"><doi>10.1111/xen.12129</doi><idGroup><id type="unit" value="XEN12129"></id></idGroup><countGroup><count number="11" type="pageTotal"></count></countGroup><titleGroup><title type="articleCategory">Review Article</title><title type="tocHeading1">REVIEW ARTICLES</title></titleGroup><copyright ownership="publisher">© 2014 John Wiley & Sons A/S Published by John Wiley & Sons Ltd.</copyright><eventGroup><event date="2014-04-13" type="manuscriptReceived"></event><event date="2014-06-20" type="manuscriptAccepted"></event><event agent="SPS" date="2014-06-30" type="xmlCreated"></event><event type="publishedOnlineEarlyUnpaginated" date="2014-09-01"></event><event type="firstOnline" date="2014-09-01"></event><event type="publishedOnlineFinalForm" date="2014-09-24"></event><event type="xmlConverted" agent="Converter:WML3G_To_WML3G version:4.6.4 mode:FullText" date="2015-10-07"></event></eventGroup><numberingGroup><numbering type="pageFirst">420</numbering><numbering type="pageLast">430</numbering></numberingGroup><correspondenceTo>Address reprint requests to Chung‐Gyu Park, Department of Microbiology and Immunology, Department of Biomedical Sciences, Cancer Research Institute, Xenotransplantation Research Center, Seoul National University College of Medicine, 103 Daehak‐ro Jongno‐gu, 110‐799 Seoul, Korea (E‐mail: <email>chgpark@snu.ac.kr</email>)</correspondenceTo><selfCitationGroup><citation type="self" xml:id="xen12129-cit-1001"><author><familyName>Kim</familyName> <givenNames>MK</givenNames></author>, <author><familyName>Choi</familyName> <givenNames>HJ</givenNames></author>, <author><familyName>Kwon</familyName> <givenNames>I</givenNames></author>, <author><familyName>Pierson</familyName> <givenNames>RN</givenNames> <nameSuffix>III</nameSuffix></author>, <author><familyName>Cooper</familyName> <givenNames>DKC</givenNames></author>, <author><familyName>Soulillou</familyName> <givenNames>J‐P</givenNames></author>, <author><familyName>O'Connell</familyName> <givenNames>PJ</givenNames></author>, <author><familyName>Vabres</familyName> <givenNames>B</givenNames></author>, <author><familyName>Maeda</familyName> <givenNames>N</givenNames></author>, <author><familyName>Hara</familyName> <givenNames>H</givenNames></author>, <author><familyName>Scobie</familyName> <givenNames>L</givenNames></author>, <author><familyName>Gianello</familyName> <givenNames>P</givenNames></author>, <author><familyName>Takeuchi</familyName> <givenNames>Y</givenNames></author>, <author><familyName>Yamada</familyName> <givenNames>K</givenNames></author>, <author><familyName>Hwang</familyName> <givenNames>E‐S</givenNames></author>, <author><familyName>Kim</familyName> <givenNames>SJ</givenNames></author>, <author><familyName>Park</familyName> <givenNames>C‐G</givenNames></author>. <articleTitle>The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of xenocorneal transplantation</articleTitle> <journalTitle>Xenotransplantation</journalTitle> <pubYear year="2014">2014</pubYear>; <vol>21</vol>: <pageFirst>420</pageFirst>–<pageLast>430</pageLast>. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.</citation></selfCitationGroup><linkGroup><link type="toTypesetVersion" href="file:XEN.XEN12129.pdf"></link></linkGroup></publicationMeta><contentMeta><titleGroup><title type="main">The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of xenocorneal transplantation</title><title type="shortAuthors">Kim et al.</title></titleGroup><creators><creator affiliationRef="#xen12129-aff-0001 #xen12129-aff-0002 #xen12129-aff-0003" creatorRole="author" xml:id="xen12129-cr-0001"><personName><givenNames>Mee Kum</givenNames> <familyName>Kim</familyName></personName></creator><creator affiliationRef="#xen12129-aff-0001 #xen12129-aff-0002 #xen12129-aff-0003" creatorRole="author" xml:id="xen12129-cr-0002"><personName><givenNames>Hyuk Jin</givenNames> <familyName>Choi</familyName></personName></creator><creator affiliationRef="#xen12129-aff-0003 #xen12129-aff-0004" creatorRole="author" xml:id="xen12129-cr-0003"><personName><givenNames>Ivo</givenNames> <familyName>Kwon</familyName></personName></creator><creator affiliationRef="#xen12129-aff-0005" creatorRole="author" xml:id="xen12129-cr-0004"><personName><givenNames>Richard N.</givenNames> <familyName>Pierson</familyName> <nameSuffix>III</nameSuffix></personName></creator><creator affiliationRef="#xen12129-aff-0006" creatorRole="author" xml:id="xen12129-cr-0005"><personName><givenNames>David K. C.</givenNames> <familyName>Cooper</familyName></personName></creator><creator affiliationRef="#xen12129-aff-0007" creatorRole="author" xml:id="xen12129-cr-0006"><personName><givenNames>Jean‐Paul</givenNames> <familyName>Soulillou</familyName></personName></creator><creator affiliationRef="#xen12129-aff-0008" creatorRole="author" xml:id="xen12129-cr-0007"><personName><givenNames>Philip J.</givenNames> <familyName>O'Connell</familyName></personName></creator><creator affiliationRef="#xen12129-aff-0009" creatorRole="author" xml:id="xen12129-cr-0008"><personName><givenNames>Bertrand</givenNames> <familyName>Vabres</familyName></personName></creator><creator affiliationRef="#xen12129-aff-0010" creatorRole="author" xml:id="xen12129-cr-0009"><personName><givenNames>Naoyuki</givenNames> <familyName>Maeda</familyName></personName></creator><creator affiliationRef="#xen12129-aff-0011" creatorRole="author" xml:id="xen12129-cr-0010"><personName><givenNames>Hidetaka</givenNames> <familyName>Hara</familyName></personName></creator><creator affiliationRef="#xen12129-aff-0012" creatorRole="author" xml:id="xen12129-cr-0011"><personName><givenNames>Linda</givenNames> <familyName>Scobie</familyName></personName></creator><creator affiliationRef="#xen12129-aff-0013" creatorRole="author" xml:id="xen12129-cr-0012"><personName><givenNames>Pierre</givenNames> <familyName>Gianello</familyName></personName></creator><creator affiliationRef="#xen12129-aff-0014" creatorRole="author" xml:id="xen12129-cr-0013"><personName><givenNames>Yasuhiro</givenNames> <familyName>Takeuchi</familyName></personName></creator><creator affiliationRef="#xen12129-aff-0015" creatorRole="author" xml:id="xen12129-cr-0014"><personName><givenNames>Kazuhiko</givenNames> <familyName>Yamada</familyName></personName></creator><creator affiliationRef="#xen12129-aff-0003 #xen12129-aff-0016" creatorRole="author" xml:id="xen12129-cr-0015"><personName><givenNames>Eung‐Soo</givenNames> <familyName>Hwang</familyName></personName></creator><creator affiliationRef="#xen12129-aff-0017" creatorRole="author" xml:id="xen12129-cr-0016"><personName><givenNames>Sang Joon</givenNames> <familyName>Kim</familyName></personName></creator><creator affiliationRef="#xen12129-aff-0003 #xen12129-aff-0016" corresponding="yes" creatorRole="author" xml:id="xen12129-cr-0017"><personName><givenNames>Chung‐Gyu</givenNames> <familyName>Park</familyName></personName></creator></creators><affiliationGroup><affiliation countryCode="KP" type="organization" xml:id="xen12129-aff-0001"><orgDiv>Department of Ophthalmology</orgDiv> <orgName>Seoul National University College of Medicine</orgName> <address><city>Seoul</city> <country>Korea</country></address></affiliation><affiliation countryCode="KP" type="organization" xml:id="xen12129-aff-0002"><orgDiv>Laboratory of Ocular Regenerative Medicine and Immunology</orgDiv> <orgDiv>Seoul Artificial Eye Center</orgDiv> <orgName>Seoul National University Hospital Biomedical Research Institute</orgName> <address><city>Seoul</city> <country>Korea</country></address></affiliation><affiliation countryCode="KP" type="organization" xml:id="xen12129-aff-0003"><orgDiv>Xenotransplantation Research Center</orgDiv> <orgDiv>Seoul National University College Of Medicine and Clinical Research Institute</orgDiv> <orgName>Seoul National University Hospital</orgName> <address><city>Seoul</city> <country>Korea</country></address></affiliation><affiliation countryCode="KP" type="organization" xml:id="xen12129-aff-0004"><orgDiv>Department of Medical Education</orgDiv> <orgDiv>School of Medicine</orgDiv> <orgName>Ewha Womans University</orgName> <address><city>Seoul</city> <country>Korea</country></address></affiliation><affiliation countryCode="US" type="organization" xml:id="xen12129-aff-0005"><orgDiv>Department of Surgery</orgDiv> <orgName>University of Maryland Medical Center</orgName> <address><city>Baltimore</city> <countryPart>MD</countryPart> <country>USA</country></address></affiliation><affiliation countryCode="US" type="organization" xml:id="xen12129-aff-0006"><orgDiv>Department of Surgery</orgDiv> <orgName>Thomas E. Starzl Transplantation Institute</orgName> <address><city>Pittsburgh</city> <countryPart>PA</countryPart> <country>USA</country></address></affiliation><affiliation countryCode="FR" type="organization" xml:id="xen12129-aff-0007"><orgDiv>Faculté de Médecine</orgDiv> <orgName>Université de Nantes</orgName> <address><city>Nantes</city> <country>France</country></address></affiliation><affiliation countryCode="AU" type="organization" xml:id="xen12129-aff-0008"><orgDiv>Centre for Transplant and Renal Research</orgDiv> <orgDiv>Westmead Millennium Institute</orgDiv> <orgName>Westmead Hospital</orgName> <address><city>Westmead</city> <countryPart>NSW</countryPart> <country>Australia</country></address></affiliation><affiliation countryCode="FR" type="organization" xml:id="xen12129-aff-0009"><orgDiv>Service d'Ophtalmologie</orgDiv> <orgName>CHU Nantes</orgName> <address><city>Nantes</city> <country>France</country></address></affiliation><affiliation countryCode="JP" type="organization" xml:id="xen12129-aff-0010"><orgDiv>Department of Ophthalmology</orgDiv> <orgName>Osaka University Medical School</orgName> <address><city>Osaka</city> <country>Japan</country></address></affiliation><affiliation countryCode="US" type="organization" xml:id="xen12129-aff-0011"><orgDiv>Thomas E. Starzl Transplantation Institute</orgDiv> <orgName>University of Pittsburgh</orgName> <address><city>Pittsburgh</city> <countryPart>PA</countryPart> <country>USA</country></address></affiliation><affiliation countryCode="GB" type="organization" xml:id="xen12129-aff-0012"><orgDiv>Department of Life Sciences</orgDiv> <orgName>Glasgow Caledonian University</orgName> <address><city>Glasgow</city> <country>UK</country></address></affiliation><affiliation countryCode="BE" type="organization" xml:id="xen12129-aff-0013"><orgName>Universite catholique de Louvain</orgName> <address><city>Brussels</city> <country>Belgium</country></address></affiliation><affiliation countryCode="GB" type="organization" xml:id="xen12129-aff-0014"><orgDiv>MRC/UCL Centre for Medical Molecular Virology and Wohl Virion Centre</orgDiv> <orgDiv>Division of Infection & Immunity</orgDiv> <orgName>University College London</orgName> <address><city>London</city> <country>UK</country></address></affiliation><affiliation countryCode="US" type="organization" xml:id="xen12129-aff-0015"><orgDiv>Transplantation Biology Research Center</orgDiv> <orgDiv>Massachusetts General Hospital</orgDiv> <orgName>Harvard Medical School</orgName> <address><city>Boston</city> <countryPart>MA</countryPart> <country>USA</country></address></affiliation><affiliation countryCode="KP" type="organization" xml:id="xen12129-aff-0016"><orgDiv>Department of Microbiology and Immunology</orgDiv> <orgName>Seoul National University College of Medicine</orgName> <address><city>Seoul</city> <country>Korea</country></address></affiliation><affiliation countryCode="KP" type="organization" xml:id="xen12129-aff-0017"><orgDiv>Organ Transplantation Center</orgDiv> <orgName>Myong‐Ji Hospital</orgName> <address><city>Goyang‐city</city> <country>Korea</country></address></affiliation></affiliationGroup><keywordGroup type="author"><keyword xml:id="xen12129-kwd-0001">consensus statement</keyword><keyword xml:id="xen12129-kwd-0002">cornea</keyword><keyword xml:id="xen12129-kwd-0003">ethics</keyword><keyword xml:id="xen12129-kwd-0004">international Guideline</keyword><keyword xml:id="xen12129-kwd-0005">regulation</keyword><keyword xml:id="xen12129-kwd-0006">xenocorneal transplantation</keyword><keyword xml:id="xen12129-kwd-0007">xenotransplantation</keyword></keywordGroup><fundingInfo><fundingAgency>Korea Healthcare Technology R&D Project</fundingAgency></fundingInfo><fundingInfo><fundingAgency>Ministry for Health, Welfare & Family Affairs, Republic of Korea</fundingAgency><fundingNumber>HI13C0954</fundingNumber></fundingInfo><supportingInformation><supportingInfoItem><mediaResource alt="supporting" mimeType="application/msword" href="urn-x:wiley:0908665X:media:xen12129:xen12129-sup-0001-AppendixS1"></mediaResource><caption><p><b>Appendix S1</b>. An example of informed consent form in clinical trials of xenocorneal transplantation.</p></caption></supportingInfoItem><supportingInfoItem><mediaResource alt="supporting" mimeType="image/tif" rendition="webOriginal" href="urn-x:wiley:0908665X:media:xen12129:xen12129-sup-0002-FigureS1"></mediaResource><caption><p><b>Figure S1.</b> An international meeting for an international consensus on xenocorneal transplantation has been held in 7th November, 2013 in Osaka during the 12th congress of IXA.</p></caption></supportingInfoItem></supportingInformation><abstractGroup><abstract type="main" xml:id="xen12129-abs-0001"><title type="main">Abstract</title><p>To develop an international consensus regarding the appropriate conditions for undertaking clinical trials in xenocorneal transplantation, here we review specific ethical, logistical, scientific, and regulatory issues regarding xenocorneal transplantation, and propose guidelines for conduct of clinical xenocorneal transplantation trials. These proposed guidelines are modeled on the published consensus statement of the International Xenotransplantation Association regarding recommended guidelines for conduct of clinical islet xenotransplantation. It is expected that this initial consensus statement will be revised over time in response to scientific advances in the field, and changes in the regulatory framework based on accumulating clinical experience.</p></abstract></abstractGroup></contentMeta></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of xenocorneal transplantation</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of xenocorneal transplantation</title></titleInfo><name type="personal"><namePart type="given">Mee Kum</namePart><namePart type="family">Kim</namePart><affiliation>Department of Ophthalmology, Seoul National University College of Medicine, Seoul, Korea</affiliation><affiliation>Laboratory of Ocular Regenerative Medicine and Immunology, Seoul Artificial Eye Center, Seoul National University Hospital Biomedical Research Institute, Seoul, Korea</affiliation><affiliation>Xenotransplantation Research Center, Seoul National University College Of Medicine and Clinical Research Institute, Seoul National University Hospital, Seoul, Korea</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Hyuk Jin</namePart><namePart type="family">Choi</namePart><affiliation>Department of Ophthalmology, Seoul National University College of Medicine, Seoul, Korea</affiliation><affiliation>Laboratory of Ocular Regenerative Medicine and Immunology, Seoul Artificial Eye Center, Seoul National University Hospital Biomedical Research Institute, Seoul, Korea</affiliation><affiliation>Xenotransplantation Research Center, Seoul National University College Of Medicine and Clinical Research Institute, Seoul National University Hospital, Seoul, Korea</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Ivo</namePart><namePart type="family">Kwon</namePart><affiliation>Xenotransplantation Research Center, Seoul National University College Of Medicine and Clinical Research Institute, Seoul National University Hospital, Seoul, Korea</affiliation><affiliation>Department of Medical Education, School of Medicine, Ewha Womans University, Seoul, Korea</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Richard N.</namePart><namePart type="family">Pierson III</namePart><affiliation>Department of Surgery, University of Maryland Medical Center, MD, Baltimore, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">David K. C.</namePart><namePart type="family">Cooper</namePart><affiliation>Department of Surgery, Thomas E. Starzl Transplantation Institute, PA, Pittsburgh, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Jean‐Paul</namePart><namePart type="family">Soulillou</namePart><affiliation>Faculté de Médecine, Université de Nantes, Nantes, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Philip J.</namePart><namePart type="family">O'Connell</namePart><affiliation>Centre for Transplant and Renal Research, Westmead Millennium Institute, Westmead Hospital, NSW, Westmead, Australia</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Bertrand</namePart><namePart type="family">Vabres</namePart><affiliation>Service d'Ophtalmologie, CHU Nantes, Nantes, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Naoyuki</namePart><namePart type="family">Maeda</namePart><affiliation>Department of Ophthalmology, Osaka University Medical School, Osaka, Japan</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Hidetaka</namePart><namePart type="family">Hara</namePart><affiliation>Thomas E. Starzl Transplantation Institute, University of Pittsburgh, PA, Pittsburgh, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Linda</namePart><namePart type="family">Scobie</namePart><affiliation>Department of Life Sciences, Glasgow Caledonian University, Glasgow, UK</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Pierre</namePart><namePart type="family">Gianello</namePart><affiliation>Universite catholique de Louvain, Brussels, Belgium</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Yasuhiro</namePart><namePart type="family">Takeuchi</namePart><affiliation>MRC/UCL Centre for Medical Molecular Virology and Wohl Virion Centre, Division of Infection & Immunity, University College London, London, UK</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Kazuhiko</namePart><namePart type="family">Yamada</namePart><affiliation>Transplantation Biology Research Center, Massachusetts General Hospital, Harvard Medical School, MA, Boston, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Eung‐Soo</namePart><namePart type="family">Hwang</namePart><affiliation>Xenotransplantation Research Center, Seoul National University College Of Medicine and Clinical Research Institute, Seoul National University Hospital, Seoul, Korea</affiliation><affiliation>Department of Microbiology and Immunology, Seoul National University College of Medicine, Seoul, Korea</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Sang Joon</namePart><namePart type="family">Kim</namePart><affiliation>Organ Transplantation Center, Myong‐Ji Hospital, Goyang‐city, Korea</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Chung‐Gyu</namePart><namePart type="family">Park</namePart><affiliation>Xenotransplantation Research Center, Seoul National University College Of Medicine and Clinical Research Institute, Seoul National University Hospital, Seoul, Korea</affiliation><affiliation>Department of Microbiology and Immunology, Seoul National University College of Medicine, Seoul, Korea</affiliation><affiliation>E-mail: chgpark@snu.ac.kr</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="review-article" displayLabel="reviewArticle" authority="ISTEX" authorityURI="https://content-type.data.istex.fr" valueURI="https://content-type.data.istex.fr/ark:/67375/XTP-L5L7X3NF-P">review-article</genre><originInfo><publisher>Blackwell Publishing Ltd</publisher><dateIssued encoding="w3cdtf">2014-09</dateIssued><dateCreated encoding="w3cdtf">2014-06-30</dateCreated><dateCaptured encoding="w3cdtf">2014-04-13</dateCaptured><dateValid encoding="w3cdtf">2014-06-20</dateValid><edition>Kim MK, Choi HJ, Kwon I, Pierson RN III, Cooper DKC, Soulillou J‐P, O'Connell PJ, Vabres B, Maeda N, Hara H, Scobie L, Gianello P, Takeuchi Y, Yamada K, Hwang E‐S, Kim SJ, Park C‐G. The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of xenocorneal transplantation Xenotransplantation 2014; 21: 420–430. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.</edition><copyrightDate encoding="w3cdtf">2014</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><abstract>To develop an international consensus regarding the appropriate conditions for undertaking clinical trials in xenocorneal transplantation, here we review specific ethical, logistical, scientific, and regulatory issues regarding xenocorneal transplantation, and propose guidelines for conduct of clinical xenocorneal transplantation trials. These proposed guidelines are modeled on the published consensus statement of the International Xenotransplantation Association regarding recommended guidelines for conduct of clinical islet xenotransplantation. It is expected that this initial consensus statement will be revised over time in response to scientific advances in the field, and changes in the regulatory framework based on accumulating clinical experience.</abstract><note type="additional physical form">Appendix S1. An example of informed consent form in clinical trials of xenocorneal transplantation.Figure S1. An international meeting for an international consensus on xenocorneal transplantation has been held in 7th November, 2013 in Osaka during the 12th congress of IXA.</note><note type="funding">Korea Healthcare Technology R&D Project</note><note type="funding">Ministry for Health, Welfare & Family Affairs, Republic of Korea - No. HI13C0954; </note><subject><genre>keywords</genre><topic>consensus statement</topic><topic>cornea</topic><topic>ethics</topic><topic>international Guideline</topic><topic>regulation</topic><topic>xenocorneal transplantation</topic><topic>xenotransplantation</topic></subject><relatedItem type="host"><titleInfo><title>Xenotransplantation</title></titleInfo><titleInfo type="abbreviated"><title>Xenotransplantation</title></titleInfo><genre type="journal" authority="ISTEX" authorityURI="https://publication-type.data.istex.fr" valueURI="https://publication-type.data.istex.fr/ark:/67375/JMC-0GLKJH51-B">journal</genre><subject><genre>article-category</genre><topic>Review Article</topic></subject><identifier type="ISSN">0908-665X</identifier><identifier type="eISSN">1399-3089</identifier><identifier type="DOI">10.1111/(ISSN)1399-3089</identifier><identifier type="PublisherID">XEN</identifier><part><date>2014</date><detail type="volume"><caption>vol.</caption><number>21</number></detail><detail type="issue"><caption>no.</caption><number>5</number></detail><extent unit="pages"><start>420</start><end>430</end><total>11</total></extent></part></relatedItem><identifier type="istex">4CFB1A3973FF6CDF4D4D1F2163273D43FBB202BC</identifier><identifier type="ark">ark:/67375/WNG-QMSCQNBJ-2</identifier><identifier type="DOI">10.1111/xen.12129</identifier><identifier type="ArticleID">XEN12129</identifier><accessCondition type="use and reproduction" contentType="copyright">© 2014 John Wiley & Sons A/S. 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