June 2015
Volume 56, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2015
The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of xenocorneal transplantation
Author Affiliations & Notes
  • Mee Kum Kim
    Ophthalmology, Seoul National University College of Medicine, Seoul
  • Hyuk Jin Choi
    Ophthalmology, Seoul National University College of Medicine, Seoul
  • Ivo Kwon
    Department of Medical Education,, Ewha Womans University, School of Medicine, Seoul, Korea (the Republic of)
  • Richard N. Pierson III
    Department of Surgery, University of Maryland Medical Center, Baltimore, MD
  • David K.C. Cooper
    Department of Surgery, Thomas E. Starzl Transplantation Institute, Pittsburgh, PA
  • Jean-Paul Soulillou
    Service d'Ophtalmologie, CHU Nantes, Nantes, France
  • Philip J O'Connell
    Centre for Transplant and Renal Research, Westmead Millennium Institute, Westmead, NSW, Australia
  • Bertrand Vabres
    Service d'Ophtalmologie, CHU Nantes, Nantes, France
  • Naoyuki Maeda
    Department of Ophthalmology, Osaka University Medical School, Osaka, Japan
  • Hidetaka Hara
    Department of Surgery, Thomas E. Starzl Transplantation Institute, Pittsburgh, PA
  • Footnotes
    Commercial Relationships Mee Kum Kim, None; Hyuk Jin Choi, None; Ivo Kwon, None; Richard N. Pierson III, None; David K.C. Cooper, None; Jean-Paul Soulillou, None; Philip J O'Connell, None; Bertrand Vabres, None; Naoyuki Maeda, None; Hidetaka Hara, None
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science June 2015, Vol.56, 2267. doi:
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      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, Consensus team; The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of xenocorneal transplantation . Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):2267.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract
 
Purpose
 

To develop an international consensus regarding the appropriate conditions for undertaking clinical trials in xenocorneal transplantation

 
Methods
 

17 international panel of experts from 7 countries (Korea, Japan, United States of America, United Kingdom, Australia, France, and Belgium) in various professional fields which include ophthalmology, ethics, infection, and international xeno-transplantation society reviewed specific ethical, logistical, scientific, and regulatory issues regarding xenocorneal transplantation, and proposed guidelines for conduct of clinical xenocorneal transplantation trials.

 
Results
 

Six topics were discussed through e-mail communications, a pre-workshop and a consensus meeting. Consensus statements were finally made on (1) Ethical requirements and regulatory framework in xenocorneal transplantation, (2) Control of Source pigs for corneal transplantation, (3) Quality control of porcine corneal products, (4) Pre-clinical efficacy and safety data that are required to justify initiating a clinical trial, (5) Strategies to prevent Porcine endogenous retrovirus transmission, and (6) Patient selection for clinical trials

 
Conclusions
 

The consensus statement is designed primarily to assist in the development of protocols for clinical trials of pig corneal transplantation.  

 
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