Introduction to the theme issue on regulatory aspects of xenotransplantation

Scobie, Linda; Schuurman, Henk‐Jan

doi:10.1111/xen.12620

Cited by 2 publications

(5 citation statements)

References 21 publications

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“…The important issue of regulation is underlined by the fact that all 3 major authorities involved, the World Health Organization, 49,143 the US Food and Drug Administration, 144 and the European Medicines Agency, recently published updates of their respective previous guidelines (reviewed in Schuurman and Hoogendoorn 142 ); the International Xenotransplantation Association dedicated its 2020 May/ June journal issue to regulatory aspects. 142,143,[145][146][147][148][149][150] Both donor animals and recipients need tight and transparent tracking; controlled long-term archiving (biobanking) of donor and recipient samples is undisputed. Only experienced groups will be allowed to proceed.…”

Section: Regulatory Challengesmentioning

confidence: 99%

Section: Regulatory Challengesmentioning

confidence: 99%

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Pathways to Clinical Cardiac Xenotransplantation

Reichart¹,

Längin

Denner

et al. 2021

Transplantation

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Heart transplantation is the only long-lasting lifesaving option for patients with terminal cardiac failure. The number of available human organs is however far below the actual need, resulting in substantial mortality of patients while waiting for a human heart. Mechanical assist devices are used to support cardiac function but are associated with a high risk of severe complications and poor quality of life for the patients. Consistent success in orthotopic transplantation of genetically modified pig hearts into baboons indicates that cardiac xenotransplantation may become a clinically applicable option for heart failure patients who cannot get a human heart transplant. In this overview, we project potential paths to clinical cardiac xenotransplantation, including the choice of genetically modified source pigs; associated requirements of microbiological, including virological, safety; optimized matching of source pig and recipient; and specific treatments of the donor heart after explantation and of the recipients. Moreover, selection of patients and the regulatory framework will be discussed.

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Section: Regulatory Challengesmentioning

confidence: 99%

Section: Regulatory Challengesmentioning

confidence: 99%

Pathways to Clinical Cardiac Xenotransplantation

Reichart¹,

Längin

Denner

et al. 2021

Transplantation

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“…The following three steps were implemented to generate an initial list of MP: All porcine MP from the Swine Health Information Center (SHIC) Viral Disease Matrix, 10 the SHIC Bacterial Disease Matrix, 11 and the Merck Veterinary manual, 12 were included; All MP mentioned in nine key xenotransplantation publications 5–7,13–18 were added; A PubMed literature search was performed in November/December 2021, using the search terms “pig + swine + porcine + pathogen + human + transmission.” The search was restricted to 1980 or later, results were sorted by PubMed's “best match,” abstracts of the top ∼10% of articles with greatest relevance as ranked by PubMed were reviewed for the identification of any MP of relevance, and those MP were added to the comprehensive list. …”

Section: Methodsmentioning

confidence: 99%

“…2. All MP mentioned in nine key xenotransplantation publications [5][6][7][13][14][15][16][17][18] were added; Subsequently, all experts were asked to review, expand and refine the initial list of MP prior to the evaluation of MP.…”

Section: Hazard Identification: Comprehensive List Of Microorganisms ...mentioning

confidence: 99%

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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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Introduction to the theme issue on regulatory aspects of xenotransplantation

Cited by 2 publications

References 21 publications

Pathways to Clinical Cardiac Xenotransplantation

Pathways to Clinical Cardiac Xenotransplantation

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

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