# Genetically-engineered pig organ transplantation in baboons: immunological and functional studies

> **NIH NIH U19** · UNIVERSITY OF ALABAMA AT BIRMINGHAM · 2021 · $1,497,588

## Abstract

GENETICALLY-ENGINEERED PIG ORGAN TRANSPLANTATION IN BABOONS: IMMUNOLOGICAL
AND FUNCTIONAL STUDIES (PI/PD: David K.C. Cooper)
OVERVIEW OF THE PROGRAM
PROJECT SUMMARY/ABSTRACT
 Our program has produced genetically-engineered pigs that protect the pig organ from injury by
the primate innate immune response. Organs transplanted from these pigs, together with an effective
(and potentially clinically-applicable) immunosuppressive regimen, have markedly extended pig graft
survival in baboons to months or even years. The current proposal aims to confirm that the combination
of a multi-gene pig and an effective immunosuppressive regimen will allow consistent function of life-
supporting pig kidneys (Project 1) and hearts (Project 3) for 6 months or longer, and of life-supporting
livers for 1 month (to act as a bridge to liver allotransplantation [Project 2]). The work in the 3 Projects
will be supported by 4 Cores.
 Core A (Pig Core) will provide specific multi-gene pigs (to Projects 1-3) that have 8 or more genetic
manipulations that will help overcome the remaining barriers to moving towards clinical trials. Core B
(Immunobiology Core) and Core C (Histopathology Core) will provide evidence of the mechanisms for
the problems being investigated and the therapeutic approaches being explored. Core D (Administrative
Core) will provide an organizational structure to facilitate the success of the proposed Projects.
 Our Aims include (i) exploring methods of preventing or suppressing the adaptive immune
response through either novel pig genetics or pharmacologic interventions, (ii) preventing or reducing the
thrombocytopenia that immediately follows pig liver transplantation in baboons, (iii) preventing or
reducing the rapid growth of pig organs documented early after transplantation into baboons, and (iv)
comprehensively monitoring function of the kidney, liver, and heart after transplantation into baboons in
the presence of a controlled immune response (i.e., in the relative absence of an immune response). The
mechanisms whereby the combination of genetic modification and refinements to the
immunosuppressive regimen prolong graft survival will be investigated by immunological assays and
histopathology techniques.
 Success in Projects 1 and 3 would allow immediate consideration of limited clinical trials of kidney
and/or heart xenotransplantation. Success in Project 2 would allow immediate consideration of a limited
clinical trial in which a pig liver is transplanted as a life-sustaining bridge to allotransplantation. The
overall goal of the 3 projects, therefore, is to advance the science during this 5-year period of funding so
that clinical trials of kidneys and hearts can be initiated as destination therapies (or, in the case of the
heart, possibly initially as a bridging therapy), and of pig livers as bridging to allotransplantation.

## Key facts

- **NIH application ID:** 10242786
- **Project number:** 5U19AI090959-13
- **Recipient organization:** UNIVERSITY OF ALABAMA AT BIRMINGHAM
- **Principal Investigator:** DAVID KC COOPER
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,497,588
- **Award type:** 5
- **Project period:** 2010-08-01 → 2022-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10242786

## Citation

> US National Institutes of Health, RePORTER application 10242786, Genetically-engineered pig organ transplantation in baboons: immunological and functional studies (5U19AI090959-13). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10242786. Licensed CC0.

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