Xenotransplantation and Infectious Diseases

Kalter, S. S.; Heberling, R. L.

doi:10.1093/ilar.37.1.31

Cited by 3 publications

(3 citation statements)

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“…Some of these viruses that do not have direct demonstrated zoonotic potential may complicate the transplant by infecting cells. 17–20,27,33,34…”

Section: Porcine Zoonotic Diseasesmentioning

confidence: 99%

“…Pathologic conditions and infectious agents to be considered include viruses, bacteria, parasites, congenital defects, neoplasia, and metabolic dysfunctions. 16–23 This article discusses the considerations that should be included in the discussion and decisions to be made concerning donor animals for xenotransplantation and potential means to meet the regulatory guidelines.…”

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confidence: 99%

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Defining Appropriate Health Status and Management Programs for Specific‐Pathogen‐Free Swine for Xenotransplantation

Swindle

1998

Annals of the New York Academy of Sciences

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Swine are expected to be utilized as xenograft donors for both whole-organ and cellular transplantation. In order to meet the criteria for regulatory guidelines, donor animals are going to have to be free of potential zoonoses and other complicating diseases. Screening of animals will have to include tests for viruses, bacteria, parasites, congenital defects, and other inapparent diseases such as neoplasia or metabolic dysfunctions. The term Specific-Pathogen-Free (SPF) swine is a proprietary designation in the U.S. that does not include screening for all appropriate organisms for xenotransplantation. A program for breeding animals as xenograft donors will have to be conducted in a biomedical research facility rather than a conventional farm setting. The research programs at such a facility should include serology, microbiology, necropsy, histology and parasitology. The use of sentinel animal monitoring in a research facility is one method to ensure compliance. It will be impossible to provide complete individual animal screening in a timely fashion prior to performing a xenograft transplant. Quality control measures need to ensure that there is a reasonable confidence that the donor tissue is appropriate for the procedure to be performed. It is suggested that a term such as xenograft-defined flora be used to designate the appropriate health status of donor animals rather than SPF in order to avoid confusion with existing standards.

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“…Some of these viruses that do not have direct demonstrated zoonotic potential may complicate the transplant by infecting cells. 17–20,27,33,34…”

Section: Porcine Zoonotic Diseasesmentioning

confidence: 99%

mentioning

confidence: 99%

Defining Appropriate Health Status and Management Programs for Specific‐Pathogen‐Free Swine for Xenotransplantation

Swindle

1998

Annals of the New York Academy of Sciences

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“…Nonhuman primates continue to make significant contributions to human health through their role in comparative biomedical research in vaccine development, toxicology, teratogenesis, reproduction, xenotransplantation, and infectious diseases along with their therapy (Schmidt 1972;Eichberg 1989;Dormont and others 1990;Kalter and Heberling 1995). With today's growing sophistication in research and technology there is a demand for a comparably high-quality animal model that was foreseen in 1972 (Neurauter and Goodwin 1972).…”

Section: Introductionmentioning

confidence: 99%

Establishing Specific Pathogen-Free (SPF) Nonhuman Primate Colonies

Buchl

Keeling²,

Voss³

1997

ILAR Journal

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Considerations of Specific Pathogen-Free Swine (SPF) in Xenotransplantation

Swindle

1996

Journal of Investigative Surgery

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The purpose of this manuscript was to introduce the complexities involved in defining both the appropriate health status and the management programs for SPF swine as they may relate to xenotransplantation. One factor that must always be considered in using swine is that they are considered agricultural animals regardless of their purpose and are regulated as such by municipalities, states, and countries. There are nonflexible regulations related to the interstate transportation of swine and even greater hurdles to international transportation. For example, I tried unsuccessfully for three years to transport a single breeding animal with a congenital heart defect to collaborators in the United Kingdom. Bureaucratic factors on both sides of the Atlantic proved insurmountable because the regulations were formulated for economic and isolation purposes and no exceptions could be granted for research animals. Another factor to be considered is the designation of SPF swine, which in this species has a specific proprietary connotation. If the finalized program for production of swine for xenotransplantation proves to be different from the already established SPF program, then a different designation may have to be used. For example, a term like "xenografic defined flora (XDF)" swine could be used to avoid confusion with the already established registry. If xenotransplantation using swine becomes a reality, then it is important that the parameters used to select such animals be defined in advance. It is unlikely that conventionally reared animals of uncertain health status will be widely accepted because of legal and ethical considerations. Likewise, I do not believe that the use of swine for xenotransplantation will be able to avoid the regulatory measures already in place for laboratory animals. The multidisciplinary approach to the problem initiated by the Institute of Medicine workshop is the most appropriate mechanism for resolving the issues.

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Xenotransplantation and Infectious Diseases

Cited by 3 publications

References 24 publications

Defining Appropriate Health Status and Management Programs for Specific‐Pathogen‐Free Swine for Xenotransplantation

Defining Appropriate Health Status and Management Programs for Specific‐Pathogen‐Free Swine for Xenotransplantation

Establishing Specific Pathogen-Free (SPF) Nonhuman Primate Colonies

Considerations of Specific Pathogen-Free Swine (SPF) in Xenotransplantation

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