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

IF 3.3 4区 医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL
Xenotransplantation Pub Date : 2023-09-01 Epub Date: 2023-08-24 DOI:10.1111/xen.12815
Huybert Groenendaal, Solenne Costard, Reid Ballard, Stephen Bienhoff, Diana C Challen, Brandon J Dominguez, Douglas R Kern, Dan Miller, Jeske Noordergraaf, Larisa Rudenko, Henk-Jan Schuurman, Tom Spizzo, Matthew Sturos, Bill Zollers, Jay A Fishman
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引用次数: 0

Abstract

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.

关于猪异种移植产品相关微生物和寄生虫的鉴定、风险评估和缓解的专家意见。
异种移植有可能解决临床移植器官短缺的问题,但人们对猪微生物和寄生虫(MP)对人类受体健康构成的潜在风险表示担忧。在这项研究中,制定了一个基于风险的框架,并根据猪暴露和对人类健康的风险,得出了评估猪MP的专家意见。专家们确定了255个MP将纳入风险评估。专家根据美国潜在的猪暴露和人类健康风险的五个标准对其进行了评级。随后,根据预先定义的规则,MP被分为三个风险缓解组:不合格的猪MP(由于其致病潜力,n=130);不合格的猪MP(仍需考虑生物安全或监测工作,n=40);和警报/观察名单(美国未报告或MP未在猪中报告,n=85)。大多数不合格(n=126)和不合格(n=36)的猪MP可以通过高生物安全计划有效消除。该方法支持异种移植猪MP的监测和风险缓解策略,如记录无猪MP,或使用猪MP筛查、监测或消除选项。据作者所知,这是首次系统、透明地全面识别所有相关的猪MP,以评估供体动物和免疫抑制的人类受体的感染风险,以及受感染的猪异种移植产品对免疫抑制的人体受体的潜在健康影响。
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来源期刊
Xenotransplantation
Xenotransplantation 医学-医学:研究与实验
CiteScore
6.80
自引率
15.40%
发文量
58
审稿时长
>12 weeks
期刊介绍: Xenotransplantation provides its readership with rapid communication of new findings in the field of organ and tissue transplantation across species barriers.The journal is not only of interest to those whose primary area is xenotransplantation, but also to veterinarians, microbiologists and geneticists. It also investigates and reports on the controversial theological, ethical, legal and psychological implications of xenotransplantation.
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