Protocol for the first clinical trial to investigate safety and efficacy of corneal xenotransplantation in patients with corneal opacity, corneal perforation, or impending corneal perforation

Hyuk Jin Choi, Chang Ho Yoon, Joon Young Hyon, Hyung Keun Lee, Jong-Suk Song, Tae Young Chung, Hyojung Mo, Jaeyoung Kim, Jae eun Kim, Bong Jin Hahm, Jaeseok Yang, Wan Beom Park, Mee Kum Kim

Research output: Contribution to journalArticle

5 Citations (Scopus)

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.

Original languageEnglish
Article numbere12446
JournalXenotransplantation
Volume26
Issue number1
DOIs
Publication statusPublished - 2019 Jan 1

Fingerprint

Corneal Perforation
Corneal Opacity
Heterologous Transplantation
Clinical Protocols
Clinical Trials
Safety
Cornea
Swine
Consent Forms
Corneal Transplantation
Organ Transplantation
Graft Survival
Blindness
Immunosuppressive Agents
Primates
Visual Acuity
Consensus
Appointments and Schedules
Transplantation
Research Personnel

Keywords

  • clinical trial
  • corneal xenotransplantation
  • porcine cornea
  • protocol
  • xenotransplantation

ASJC Scopus subject areas

  • Immunology
  • Transplantation

Cite this

Protocol for the first clinical trial to investigate safety and efficacy of corneal xenotransplantation in patients with corneal opacity, corneal perforation, or impending corneal perforation. / Choi, Hyuk Jin; Yoon, Chang Ho; Hyon, Joon Young; Lee, Hyung Keun; Song, Jong-Suk; Chung, Tae Young; Mo, Hyojung; Kim, Jaeyoung; Kim, Jae eun; Hahm, Bong Jin; Yang, Jaeseok; Park, Wan Beom; Kim, Mee Kum.

In: Xenotransplantation, Vol. 26, No. 1, e12446, 01.01.2019.

Research output: Contribution to journalArticle

Choi, Hyuk Jin ; Yoon, Chang Ho ; Hyon, Joon Young ; Lee, Hyung Keun ; Song, Jong-Suk ; Chung, Tae Young ; Mo, Hyojung ; Kim, Jaeyoung ; Kim, Jae eun ; Hahm, Bong Jin ; Yang, Jaeseok ; Park, Wan Beom ; Kim, Mee Kum. / Protocol for the first clinical trial to investigate safety and efficacy of corneal xenotransplantation in patients with corneal opacity, corneal perforation, or impending corneal perforation. In: Xenotransplantation. 2019 ; Vol. 26, No. 1.
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AU - Choi, Hyuk Jin

AU - Yoon, Chang Ho

AU - Hyon, Joon Young

AU - Lee, Hyung Keun

AU - Song, Jong-Suk

AU - Chung, Tae Young

AU - Mo, Hyojung

AU - Kim, Jaeyoung

AU - Kim, Jae eun

AU - Hahm, Bong Jin

AU - Yang, Jaeseok

AU - Park, Wan Beom

AU - Kim, Mee Kum

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N2 - 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.

AB - 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.

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