title: The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of xenocorneal transplantation.
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.
authors.affiliation: Department of Ophthalmology, Seoul National University College of Medicine, Seoul, Korea; Laboratory of Ocular Regenerative Medicine and Immunology, Seoul Artificial Eye Center, Seoul National University Hospital Biomedical Research Institute, Seoul, Korea; Xenotransplantation Research Center, Seoul National University College Of Medicine and Clinical Research Institute, Seoul National University Hospital, Seoul, Korea.
authors.forename: Mee Kum
authors.initials: MK
authors.lastname: Kim
authors.forename: Hyuk Jin
authors.initials: HJ
authors.lastname: Choi
authors.forename: Ivo
authors.initials: I
authors.lastname: Kwon
authors.forename: Richard N
authors.initials: RN
authors.lastname: Pierson
authors.forename: David K C
authors.initials: DK
authors.lastname: Cooper
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Soulillou
authors.forename: Philip J
authors.initials: PJ
authors.lastname: O'Connell
authors.forename: Bertrand
authors.initials: B
authors.lastname: Vabres
authors.forename: Naoyuki
authors.initials: N
authors.lastname: Maeda
authors.forename: Hidetaka
authors.initials: H
authors.lastname: Hara
authors.forename: Linda
authors.initials: L
authors.lastname: Scobie
authors.forename: Pierre
authors.initials: P
authors.lastname: Gianello
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Takeuchi
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Yamada
authors.forename: Eung-Soo
authors.initials: ES
authors.lastname: Hwang
authors.forename: Sang Joon
authors.initials: SJ
authors.lastname: Kim
authors.forename: Chung-Gyu
authors.initials: CG
authors.lastname: Park
mesh_terms: D000818:Animals; D002986:Clinical Trials as Topic / Q000941:ethics / Q000379:methods / Q000592:standards*; D016039:Corneal Transplantation / Q000941:ethics / Q000379:methods* / Q000592:standards; D006801:Humans; D007258:Informed Consent; D018579:Patient Selection; D013552:Swine; D014183:Transplantation, Heterologous / Q000941:ethics / Q000379:methods* / Q000592:standards
keywords: consensus statement; cornea; ethics; international Guideline; regulation; xenocorneal transplantation; xenotransplantation