Xenotransplantation and its Associated Safety and Ethical Issues
Mary E. White-Scharf. Vice President of Research,
Biotransplant, Inc.
Glossary: endogenous
Xenotransplantation, Safety and Ethical Issues
- Xenotransplantation: Transplantation of tissue from one species to
another
- Allotransplantation: Transplantation of tissue from one individual to
another within a given species
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Types of Xenotransplantation
- Cell Transplants
Islets
Fetal neural
- Ex vivo Organ Assist
Liver
- Solid Organ Transplants
Heart
Kidney
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Non-human Primates as Donors
Breeding Issues
- Long gestation period
- Single births
- Lack of controlled environment
Ethical Issues
- Non-human primates are genetically more closely related to humans
Potential Health Risks
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Regulatory Update
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Pigs as Organ Donors
Breeding Issues
- Short gestation period
- Born in litters
- Barrier facilities established
Ethical Issues
- Over 93 million pigs per year in the US are slaughtered for food
Potential Health Risks
- Exogenous viruses: eliminated by raising in barrier facilities
- Endogenous retroviruses: no pathogens identified
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Advantage of Inbred Miniature Swine
- MHC Inbred and Recombinant Lines are Available
- Twenty-five Years of Breeding and Medical History
- Physiology Similar to that of Humans
- Transplantation Technology Available Including Species Specific
Cytokines and Antibody Reagents
- Model Consistent with Clinical Findings
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Scientific Issues Associated with Xenotransplantation
Two Major Hurdles
- Humans have naturally occurring antibodies which react with
carbohydrates on the surface of pig cells
- The human immune response to xenogeneic tissue is very strong and
difficult to manage
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Major Scientific Approaches to Achieving Xenotransplantation
- Develop Specific Immune Tolerance
- Genetically Engineer Pigs
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Ethical Issues Associated with Xenotransplantation
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Potential Health Risks
- Risks to the Patient
- Risks to Society
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Risks to the Patient
- Allotransplants
HIV, Hepatitis, CMV
- Xenotransplants
PERVs, unknown viruses
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Risks to Society
- Potential for Recombination Among Pig and Human Retroviruses to Form
Pathogenic, Infectious Strains
- Potential for Emergence of Unknown Zoonosis
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What Can Be Done to Manage Risks?
- Identify and Characterize PERVs
- Develop Assays to Monitor Infection
- Acquire and Test Samples
From individuals with long-term exposure to pigs or pig products, such
as pig farmers
From burn patients who had pig skin transplants
- Perform Carefully Controlled and Well Monitored Clinical Studies in a
Limited Number of Individuals
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Email
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