Early testing of porcine organ xenotransplantation products in humans: Microbial safety as illustrated for porcine cytomegalovirus

Denner, Joachim; Schuurman, Henk‐Jan

doi:10.1111/xen.12783

Cited by 7 publications

(7 citation statements)

References 84 publications

(142 reference statements)

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“…The clinical features and the steadily increasing virus load observed in the patient in Baltimore are very similar to the features and high virus load observed in baboons, which received a PCMV/PRV‐positive heart in Munich 8 . Therefore, it is likely that the virus contributed together with other factors to the death of the patient 12–16 . These additional factors were surgical problems, problems with immunosuppression, application of the IVIG, and the antiviral drugs (see below).…”

Section: Figuresupporting

confidence: 57%

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First transplantation of a pig heart from a multiple gene‐modified donor, porcine cytomegalovirus/roseolovirus, and antiviral drugs

Denner

2023

Xenotransplantation

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Section: Figuresupporting

confidence: 57%

“…Xenotransplantation published by John Wiley & Sons Ltd. patient. [12][13][14][15][16] These additional factors were surgical problems, problems with immunosuppression, application of the IVIG, and the antiviral drugs (see below).…”

mentioning

confidence: 99%

First transplantation of a pig heart from a multiple gene‐modified donor, porcine cytomegalovirus/roseolovirus, and antiviral drugs

Denner

2023

Xenotransplantation

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“…The recent report on the first heart transplant from a genetically modified pig illustrates the possibility of porcine MP transmission from source animals 33,34 . This study presents a risk‐based evaluation of porcine MP relevant to xenotransplantation from pigs to support the development of risk mitigation strategies to optimize xenotransplantation safety.…”

Section: Discussionmentioning

confidence: 95%

“…The recent report on the first heart transplant from a genetically modified pig illustrates the possibility of porcine MP transmission from source animals. 33,34 This study presents a risk-based evalu-…”

Section: Namementioning

confidence: 99%

Expert opinion on the identification, risk assessment, and mitigation of microorganisms and parasites relevant to xenotransplantation products from pigs

Groenendaal,

Costard,

Ballard

et al. 2023

Xenotransplantation

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Xenotransplantation has the potential to address shortages of organs available for clinical transplantation, but concerns exist regarding potential risks posed by porcine microorganisms and parasites (MP) to the health of human recipients. In this study, a risk‐based framework was developed, and expert opinion was elicited to evaluate porcine MP based on swine exposure and risk to human health. Experts identified 255 MP to include in the risk assessment. These were rated by experts for five criteria regarding potential swine exposure in the USA and human health risks. MP were subsequently categorized into three risk mitigation groups according to pre‐defined rules: disqualifying porcine MP (due to their pathogenic potential, n = 130); non‐disqualifying porcine MP (still relevant to consider for biosecurity or monitoring efforts, n = 40); and alert/watch list (not reported in the USA or MP not in swine, n = 85). Most disqualifying (n = 126) and non‐disqualifying (n = 36) porcine MP can effectively be eliminated with high biosecurity programs. This approach supports surveillance and risk mitigation strategies for porcine MP in swine produced for xenotransplantation, such as documentation of freedom from porcine MP, or use of porcine MP screening, monitoring, or elimination options. To the authors’ knowledge, this is the first effort to comprehensively identify all relevant porcine MP systematically and transparently evaluate the risk of infection of both donor animals and immunosuppressed human recipients, and the potential health impacts for immunosuppressed human recipients from infected xenotransplantation products from pigs.

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“…Additionally, he provided guidelines for maintaining biosecurity barrier facilities and presented regulatory aspects related to xenotransplantation. He illustrated the necessity of regulatory oversight by referring to the pig heart carried out at the University of Maryland, in which regulatory involvement related only to the authorization of expanded access ("compassionate use") 5,10. In regulatory terms, a pig organ is a xenotransplantation product, in contrast to a human donor organ, emphasizing the importance of safety and regulation for future clinical applications.Dengke Pan reported that his company, Clonorgan Biotechnology, has generated more than 10 different combinations of gene-edited pigs, including GTKO, B4GalNT2KO, CMAHKO,11 SLA-IKO, with expression of hCD55, hCD46, hTBM, hEPCR, hCD47, and CTLA4Ig.…”

mentioning

confidence: 99%

Meeting report: Xenotransplantation Development Conference in Neijiang, China

Huai,

Schuurman,

Cooper

et al. 2023

Xenotransplantation

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A conference on progress in the development of xenotransplantation in China was held in Neijiang, Sichuan, in May 2023, and was attended by approximately 100 established researchers and trainees. Progress in xenotransplantation research was reviewed by both Chinese and foreign experts. The topics discussed ranged from genetic engineering of pigs and the results of pig‐to‐nonhuman primate organ transplantation to the requirements for designated pathogen‐free (DPF) pig facilities and regulation of xenotransplantation. This conference served as an opportunity to collectively advance the development of xenotransplantation in China and pave the way for its clinical application.

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Early testing of porcine organ xenotransplantation products in humans: Microbial safety as illustrated for porcine cytomegalovirus

Cited by 7 publications

References 84 publications

First transplantation of a pig heart from a multiple gene‐modified donor, porcine cytomegalovirus/roseolovirus, and antiviral drugs

First transplantation of a pig heart from a multiple gene‐modified donor, porcine cytomegalovirus/roseolovirus, and antiviral drugs

Expert opinion on the identification, risk assessment, and mitigation of microorganisms and parasites relevant to xenotransplantation products from pigs

Meeting report: Xenotransplantation Development Conference in Neijiang, China

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