Hyuk Jin Choi1,2,3,4, Chang Ho Yoon1,2,3, Joon Young Hyon1,5,6, Hyung Keun Lee5,7, Jong-Suk Song5,8, Tae-Young Chung5,9, Hyojung Mo10,11, Jaeyoung Kim12, Jae-Eun Kim13, Bong-Jin Hahm14, Jaeseok Yang15, Wan Beom Park16, Mee Kum Kim1,2,3,5. 1. Department of Ophthalmology, Seoul National University College of Medicine, Seoul, Korea. 2. Laboratory of Ocular Regenerative Medicine and Immunology, Seoul Artificial Eye Center, Seoul National University Hospital Biomedical Research Institute, Seoul, Korea. 3. Translational Xenotransplantation Research Center, Seoul National University College of Medicine and Seoul National University Hospital Biomedical Research Institute, Seoul, Korea. 4. Department of Ophthalmology, Seoul National University Hospital Healthcare System Gangnam Center, Seoul, Korea. 5. Executive Council, Korean External Eye Disease Society, Seoul, Korea. 6. Department of Ophthalmology, Seoul National University Bundang Hospital, Seoul, Korea. 7. Department of Ophthalmology, Yonsei University College of Medicine, Seoul, Korea. 8. Department of Ophthalmology, Korea University College of Medicine, Seoul, Korea. 9. Department of Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. 10. Center for Public Healthcare Education & Training, National Medical Center, Seoul, Korea. 11. Executive Ethical Committee of the Xenotransplantation Research Center, Seoul, Korea. 12. Inje University Seoul Paik Hospital, Seoul, Korea. 13. C&R Research Inc., Seoul, Korea. 14. Department of Psychiatry and Behavioral Science, Seoul National University College of Medicine, Seoul, Korea. 15. Department of Surgery, Transplantation Center, Seoul National University Hospital and Transplantation Research Institute, Seoul National University College of Medicine, Seoul, Korea. 16. Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
Abstract
BACKGROUND: Xenotransplantation using fresh porcine corneas has been suggested as a feasible alternative to overcome the shortage of human donor corneas. Successful long-term survival of grafts without evidence of xenozoonosis in clinically applicable pig-to-non-human primate corneal transplantation model has brought researchers close to human clinical trials. Accordingly, we aimed to prepare a clinical trial protocol to conduct the first corneal xenotransplantation. METHODS: We developed the clinical trial protocol based on international consensus statement on conditions for undertaking clinical trials of corneal xenotransplantation developed by the International Xenotransplantation Society. Detailed contents of the protocol have been modified with reference to comments provided by ophthalmologists and multidisciplinary experts, including an infectionist, an organ transplantation specialist, a clinical pharmacologist, a neuropsychiatrist, a laboratory medicine doctor, and a microbiologist. RESULTS: Two patients with bilateral legal corneal blindness (best-corrected visual acuity ≤20/200 in the better eye and ≤20/1000 in the candidate eye) or with (impending) corneal perforation will be enrolled. During the screening period, participants and their family members will have two separate deep consideration periods before signing informed consent forms. Each patient will undergo corneal xenotransplantation using fresh corneas from Seoul National University miniature pigs. Commercially available immunosuppressants will be administered and systemic infection prophylaxis will be performed according to the program schedule. After transplantation, each patient will be monitored at a specialized clinic to investigate safety up to 2 years and efficacy up to 1 year. CONCLUSIONS: A detailed clinical trial protocol for the first corneal xenotransplantation reflecting the global guidelines is provided.
BACKGROUND: Xenotransplantation using fresh porcine corneas has been suggested as a feasible alternative to overcome the shortage of humandonor corneas. Successful long-term survival of grafts without evidence of xenozoonosis in clinically applicable pig-to-non-human primate corneal transplantation model has brought researchers close to human clinical trials. Accordingly, we aimed to prepare a clinical trial protocol to conduct the first corneal xenotransplantation. METHODS: We developed the clinical trial protocol based on international consensus statement on conditions for undertaking clinical trials of corneal xenotransplantation developed by the International Xenotransplantation Society. Detailed contents of the protocol have been modified with reference to comments provided by ophthalmologists and multidisciplinary experts, including an infectionist, an organ transplantation specialist, a clinical pharmacologist, a neuropsychiatrist, a laboratory medicine doctor, and a microbiologist. RESULTS: Two patients with bilateral legal corneal blindness (best-corrected visual acuity ≤20/200 in the better eye and ≤20/1000 in the candidate eye) or with (impending) corneal perforation will be enrolled. During the screening period, participants and their family members will have two separate deep consideration periods before signing informed consent forms. Each patient will undergo corneal xenotransplantation using fresh corneas from Seoul National University miniature pigs. Commercially available immunosuppressants will be administered and systemic infection prophylaxis will be performed according to the program schedule. After transplantation, each patient will be monitored at a specialized clinic to investigate safety up to 2 years and efficacy up to 1 year. CONCLUSIONS: A detailed clinical trial protocol for the first corneal xenotransplantation reflecting the global guidelines is provided.
Authors: Ghasem Yazdanpanah; Ritu Shah; Sri Raghurama R Somala; Khandaker N Anwar; Xiang Shen; Seungwon An; Meisam Omidi; Mark I Rosenblatt; Tolou Shokuhfar; Ali R Djalilian Journal: Ocul Surf Date: 2021-04-22 Impact factor: 6.268