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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, ; 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)
To develop an international consensus regarding the appropriate conditions for undertaking clinical trials in xenocorneal transplantation
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.
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
The consensus statement is designed primarily to assist in the development of protocols for clinical trials of pig corneal transplantation.
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