Third <scp>WHO</scp> Global Consultation on Regulatory Requirements for Xenotransplantation Clinical Trials, Changsha, Hunan, China December 12–14, 2018

Hawthorne, Wayne J.; Cowan, Peter J.; Bühler, Léo H.; Yi, Shounan; Bottino, Rita; Pierson, Richard N.; Ahn, Curie; Azimzadeh, Agnes M.; Cozzi, Emanuele; Gianello, Pierre; Lakey, Jonathan R. T.; Luo, Min‐Hua; Miyagawa, Shuji; Mohiuddin, Muhammad M.; Park, Chung Gyu; Schuurman, Henk Jan; Scobie, Linda; Sykes, Megan; Tector, Joseph; Tönjes, Ralf R.; Wolf, Eckhard; Núñez, José R.; Wang, Wei

doi:10.1111/xen.12513

Cited by 61 publications

(71 citation statements)

References 3 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Recombinant virus PERV-A/C exhibits increased infectivity toward human cells (187). Therefore, the International Xenotransplantation Association recommends that the donor pig for xenotransplantation be free of PERV-C (188).…”

Section: Porcine Endogenous Retroviruses In Xenotransplantationmentioning

confidence: 99%

Xenotransplantation: Current Status in Preclinical Research

et al. 2020

View full text Add to dashboard Cite

Section: Porcine Endogenous Retroviruses In Xenotransplantationmentioning

confidence: 99%

Xenotransplantation: Current Status in Preclinical Research

et al. 2020

View full text Add to dashboard Cite

“…In 2020, the Regulation is most likely to replace the current European Clinical Trial Directive 2001/20/EC. The assessment of a clinical trial application will proceed through twofold procedures: The Reporting Member State should evaluate the scientific features of the trial (part 1), and each Concerned Member State should conduct a separate assessment covering national features (part 2) ( Hawthorne et al, 2019 ).…”

Section: Regulatory Framework and Ethical Issues In Xenotransplantatimentioning

confidence: 99%

Corneal xenotransplantation: Where are we standing?

Yoon¹,

Choi²,

Kim

2021

Progress in Retinal and Eye Research

View full text Add to dashboard Cite

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.

show abstract

“…In 2001, "WHO Guidance on Xenogeneic Infection/Disease Surveillance and Response; A strategy for international Cooperation and Coordination" was published. 26 In 2008, WHO published the First WHO Global Consultation on Regulatory Requirements for Xenotransplantation Clinical Trials (The Changsha Communique), which included 10 principles (Table 5), key recommendations for WHO, member states, and investigators. 27 The 10 principles of the Changsha Communique consisted of (a) the potential benefit of xenotransplantation, (b) the safe animal source, (c) the potential risk of developing new serious infection, (d) effective regulation, (e) high benefit to risk balance, (f) justification of clinical trial and informed consent, (g) long-term storage of samples and records, (h) medical team expertise and plans to identify and respond to xenotransplantation related infection, (i) global information exchange, and (j) public sector support ( Table 5).…”

Section: Regulation To Prevent Xenogeneic Infectionmentioning

confidence: 99%

“…30 In 2019, the third WHO Global Consultation on Regulatory Requirement for Xenotransplantation Clinical Trials was held in Changsha. 26 Some recommendations were modified and two recommendations were newly added. The new recommendations are developing quality control measures and standards for genetically modified pigs and making the devices and biomaterials compliant with current international standards.…”

Section: Regulation To Prevent Xenogeneic Infectionmentioning

confidence: 99%

Current situation of clinical islet transplantation from allogeneic toward xenogeneic

Matsumoto

Shimoda

2020

Journal of Diabetes

View full text Add to dashboard Cite

Currently, type 1 diabetes requires lifelong insulin injection and careful blood glucose control to prevent secondary complications, but islet transplantation could make a type 1 diabetic patient insulin independent. On the other hand, islet transplantation needs human donors and donor shortage is the most serious issue. To alleviate the donor shortage, non‐heart‐beating and living donors were used; in addition, the efficacy of islet isolation and transplantation has been improved. However, the donor shortage issue will not be solved as long as human donors are the only source. To solve the donor shortage issue, islet xenotransplantation using porcine islets was initiated in 1994. Islet xenotransplantation has a potential to cure many type 1 diabetic patients, although there is the risk of developing serious or novel infection. Therefore, the World Health Organization has been interested in xenotransplantation, and the International Xenotransplantation Association (IXA) has published consensus statements to initiate xenogeneic islet transplantation. Clinical islet xenotransplantation was conducted under the official regulation, and safety and efficacy data have been accumulated. Currently an efficient method to overcome xenorejection is an important research target. In addition to traditional immunosuppressive drugs and immune isolation methods, the gene modification with CRISPR and blastocyst complementation have been investigated with promising outcomes. Once the xenorejection issue is overcome, islet xenotransplantation should become a curative treatment for type 1 diabetic patients.

show abstract

Third WHO Global Consultation on Regulatory Requirements for Xenotransplantation Clinical Trials, Changsha, Hunan, China December 12–14, 2018

Abstract: be posted on the websites of WHO, IXA, and TTS, and published in Xenotransplantation.This report includes summaries of the various sessions, followed by the abstracts of invited speakers from the update sessions.

Cited by 61 publications

References 3 publications

Xenotransplantation: Current Status in Preclinical Research

Xenotransplantation: Current Status in Preclinical Research

Corneal xenotransplantation: Where are we standing?

Current situation of clinical islet transplantation from allogeneic toward xenogeneic

Contact Info

Product

Resources

About