Standardization of the proceedings for preparing clinical trials of corneal xenotransplantation in South Korea

Choi, Hyuk Jin; Hyon, Joon Young; Song, Jong Suk; Chung, Tae Young; HyoJung, Mo; Kim, Jae Eun; Yoo, Hyounggyoon; Lee, Seung Hwan; Kwon, Illoong; Kim, Mee Kum

doi:10.1111/xen.12448

Cited by 5 publications

(4 citation statements)

References 15 publications

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“…10 ). Given the proof-of-concept NHP study that included anti-CD20 Ab, tacrolimus, and CS ( Choi et al, 2019a ), similar immunosuppressant regimen will be adopted in a clinical trial ( Choi et al, 2019b ). The protocol was developed based on the advice obtained from multidisciplinary consulting boards as follows.…”

Section: Current Status On Clinical Trials In Xenotransplantationmentioning

confidence: 99%

“…Data and Safety Monitoring Board (DSMB) is independently organized, and will evaluate the safety, monitor the overall process of the trial and advise to continue/discontinue or modify the trial. The principal investigator should respond promptly to any suggestions of the DSMB ( Choi et al, 2019a , 2019b ). During clinical trials, the results will be periodically submitted to the IRB and DSMB.…”

Section: Current Status On Clinical Trials In Xenotransplantationmentioning

confidence: 99%

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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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Section: Current Status On Clinical Trials In Xenotransplantationmentioning

confidence: 99%

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

Self Cite

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“…The close contacts, or sometimes the family members who are not close contacts, should give their consent to the engagement of their spouse or parents in xenotransplant clinical trials. It is the background of developing “multi‐tier informed consent process” by the XRC in Korea 27,28 …”

Section: Addressing Specific Issues Of Xenotransplant Clinical Trial mentioning

confidence: 99%

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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“…The recent celebration of the 20 th anniversary of the International Xenotransplantation Association [8], highlights the world-wide spread of xenotransplantation research beyond United States and Europe for acquiring techniques that could potentially offer unlimited supply of transplantable organs to patients on the waiting list across the world [9][10][11][12].…”

Section: Introductionmentioning

confidence: 99%

The potential role of 3D-bioprinting in xenotransplantation

Zhang

Smith

et al. 2019

Current Opinion in Organ Transplantation

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Purpose of review To review the impact of a new technology, 3D-bioprinting, in xenotransplantation research. Recent findings Genetically-engineered pigs, beginning with human (h) CD55-transgenic and Gal-knockout pigs, have improved the outcomes of xenotransplantation research. Today, there are >30 different genetically-engineered pigs either expressing human gene(s) or lacking pig gene(s). CRIPSR/cas9 technology has facilitated the production of multigene pigs (up to 9-genes in a single pig) which lack multiple pig xenoantigens, and express human transgenes, such as hCD46, hCD55, hThrombomodulin, hCD39, etc. Although recent studies in nonhuman primates (NHPs) have demonstrated prolonged survival after life-supporting pig kidney, heart, and islet xenotransplantation, researchers have difficulty determining the best genetic combination to test in NHPs due to a potential >100,000 genetic combinations. 3D-bioprinting of genetically-engineered pig cells (i) is superior to 2D in vitro testing, (ii) enables organ-specific testing, (iii) helps to understand differences in immunogenicity between organs, and (iv) is faster and cheaper than testing in NHPs. Moreover, 3D-bioprinted cells can be continuously perfused in a bioreactor, controlling for all variables, except the studied variable. Summary 3D-bioprinting can help in the study of the impact of specific genes (human or pig) in xenotransplantation in a rapid, inexpensive, and reliable way.

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Standardization of the proceedings for preparing clinical trials of corneal xenotransplantation in South Korea

Cited by 5 publications

References 15 publications

Corneal xenotransplantation: Where are we standing?

Corneal xenotransplantation: Where are we standing?

Regulatory aspects of xenotransplantation in Korea

The potential role of 3D-bioprinting in xenotransplantation

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