Current status of xenotransplantation in South Korea

Park, Chung Gyu; Shin, Jong Son; Min, Bon Hong; Kim, Hyunil; Yeom, Su Cheong; Ahn, Curie

doi:10.1111/xen.12488

Cited by 8 publications

(7 citation statements)

References 39 publications

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“…In Korea, a group of investigators has been conducting research especially in the field of porcine pancreatic islet cells and corneal xenotransplantation, in the Xenotransplantation Research Center (XRC) supported by the Korean government since 2005. The XRC achieved quite successful results in the preclinical trial with non‐human primates, which satisfies the requirements of the Changsha Communique in terms of scientific pre‐condition for the xenotransplantation clinical trial subjected to human 14 . Korean investigators have been preparing the necessary procedures and protocols for porcine pancreatic islets and corneal clinical trials with human subjects since 2012.…”

Section: Korean Research Group (Xrc) and Clinical Trials Of Xenotransmentioning

confidence: 78%

Regulatory aspects of xenotransplantation in Korea

Kwon

Park

Lee

2020

Xenotransplantation

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Background The xenotransplant clinical trial with human subjects seems to be technically feasible, however, it needs the strict regulatory framework from the domestic as well as the international level to make sure the safety of the human subject and the general public. Methods The authors reviewed and introduced the current regulations regarding the xenotransplant clinical trial in Korea focusing on the recently stipulated act (Advanced Regenerative Medicine and Biopharmacology Act, ARMBA) and the role of the related government agencies and health institutions. Results and Conclusion Korea is ready to conduct the xenotransplant clinical trial with human subjects in the current regulatory framework satisfying the requirements of the international guidance. The responsible governmental agencies would collaborate in control the xenotransplant clinical trial under the ARMBA and other related acts and guidance.

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Section: Korean Research Group (Xrc) and Clinical Trials Of Xenotransmentioning

confidence: 78%

Regulatory aspects of xenotransplantation in Korea

Kwon

Park

Lee

2020

Xenotransplantation

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“…This facility has maintained DPF colony of SNU miniature pigs. Recently, SNU and National Institute of Animal Science established qualified DPF pig facilities additionally that can accommodate 100–150 minipigs ( Park et al, 2019 ).…”

Section: Current Status On Clinical Trials In Xenotransplantationmentioning

confidence: 99%

“…Participants must be enrolled after full assessment of risks and benefits of corneal xenotransplantation based on the international consensus statement ( Kim et al, 2014 ). The clinical protocol for corneal xenotransplantation received the approval from the IRB in Korea ( Choi et al, 2019b ) and was modified by the IXA and the Transplantation Society ethics committee to ensure its safety and transparency after the field inspection ( Park et al, 2019 ). The latest revised inclusion and exclusion criteria of subjects for a clinical trial in corneal xenotransplantation are shown in Table 15 .…”

Section: Current Status On Clinical Trials In Xenotransplantationmentioning

confidence: 99%

Corneal xenotransplantation: Where are we standing?

Yoon¹,

Choi²,

Kim

2021

Progress in Retinal and Eye Research

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The search for alternatives to allotransplants is driven by the shortage of corneal donors and is demanding because of the limitations of the alternatives. Indeed, current progress in genetically engineered (GE) pigs, the introduction of gene-editing technology by clustered regularly interspaced short palindromic repeats (CRISPR)-Cas9, and advanced immunosuppressants have made xenotransplantation a possible option for a human trial. Porcine corneal xenotransplantation is considered applicable because the eye is regarded as an immune-privileged site. Furthermore, recent non-human primate studies have shown long-term survival of porcine xenotransplants in keratoplasty. Herein, corneal immune privilege is briefly introduced, and xenogeneic reactions are compared with allogeneic reactions in corneal transplantation. This review describes the current knowledge on special issues of xenotransplantation, xenogeneic rejection mechanisms, current immunosuppressive regimens of corneal xenotransplantation, preclinical efficacy and safety data of corneal xenotransplantation, and updates of the regulatory framework to conduct a clinical trial on corneal xenotransplantation. We also discuss barriers that might prevent xenotransplantation from becoming common practice, such as ethical dilemmas, public concerns on xenotransplantation, and the possible risk of xenozoonosis. Given that the legal definition of decellularized porcine cornea (DPC) lies somewhere between a medical device and a xenotransplant, the preclinical efficacy and clinical trial data using DPC are included. The review finally provides perspectives on the current standpoint of corneal xenotransplantation in the fields of regenerative medicine.

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“…Since 2005, the Korean government has supported porcine pancreatic islet cell and corneal xenotransplantation 10 . Investigators in Korea have been successful with pre‐clinical non‐human primates transplants that also satisfies the requirements of the Changsha Communique for pre‐conditioning of xenotransplantation clinical trials 11 . Although Korean investigators have been preparing for human clinical trials, there has never been any specific regulatory framework for xenotransplantation such as dealing with regulatory and bioethical concerns.…”

Section: Regulatory Aspects Of Xenotransplantation In Koreamentioning

confidence: 99%