kidney xenotransplantation - the next great breakthrough in nephrology? david k.c. cooper md, phd,...
TRANSCRIPT
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KIDNEY XENOTRANSPLANTATION- THE NEXT GREAT BREAKTHROUGH IN
NEPHROLOGY?
David K.C. Cooper MD, PhD, FRCS Thomas E. Starzl Transplantation Institute
University of Pittsburgh
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COMPETING INTERESTS
I am Chairman of the Scientific Advisory Board of Revivicor, Inc., Blacksburg, VA, but I have no financial interest in the company and do not receive any remuneration whatsoever.
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REVIVICOR
Small biotechnology company (25 staff) that concentrates its effort on the genetic engineering of pigs for medical purposes:
1. Xenotransplantation 2. Human immunoglobulin
(also for biodefense)
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ACKNOWLEDGEMENTS
Many colleagues at STI, Allegheny GeneralHospital, and Revivicor
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HISTORY OF XENOTRANSPLANTATION
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XENOTRANSPLANTATION:
THE PIG AS THE ORGAN-SOURCE
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XENOTRANSPLANTATION
Advantages 1:
1. Unlimited supply of donor organs.
2. Organs available electively.
3. Avoids effects of brain death.
4. Infection-free donors.
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XENOTRANSPLANTATION
Advantages 2:
1. Borderline candidates
2. “Cultural” barriers to deceased donation (e.g. Japan)
3. Diabetes mellitus/cell transplants
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CLINICAL PIG-TO-HUMAN XENOTRANSPLANTATION
Organs (kidney, heart, liver, lung)IsletsCorneas Neuronal cellsHepatocytesSkinRed blood cells
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XENOTRANSPLANTATION:
BARRIERS
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BARRIERS TO XENOTRANSPLANTATION
IMMUNOLOGIC Physiologic Safety (risk of infection) Ethical Regulatory / Legal
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BARRIERS TO XENOTRANSPLANTATION
“Immunologic” includes: 1. Innate immune response (e.g.,
antibody, complement, macrophages)
2. Adaptive immune response (e.g., T and B cells)
3. Coagulation dysfunction (e.g., thrombin, platelets)
4. Inflammation
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PIG ORGAN XENOTRANSPLANTATION
IN NONHUMAN PRIMATES
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PIG-TO-BABOON KIDNEY TX (DAY 0)
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PIG-TO-BABOON KIDNEY TX (HAR)
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PORCINE HUMAN
αGal
NeuGc
ß4GalNT2
ABH
NeuAc
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XENOTRANSPLANTATION:
EXPERIMENTAL PROGRESS
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Solution 1
Gene-knockout of known antigenic targets for human anti-pig antibodies, e.g., αGal, NeuGc, ß4GalNT2
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WT
GTKO/CD46
GTKO/CD46
/Neu
GcKO
Human
0
2
4
6
8
Rel
ativ
e M
FI
Human antibody binding to the AECs
*p<0.05 (n=6)
WT
GTKO/CD46
GTKO/CD46
/Neu
GcKO
Human
0
10
20
30
40
50
Rel
ativ
e M
FI
* *
*
*
**
IgM IgG
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Solution 2
Pigs transgenic for a human protein, e.g., complement-
regulatory, coagulation-regulatory, anti-inflammatory, immunosuppressive agent
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IsotypeGE pig AECs
Human AECs
Surface expression on genetically-engineered (GE) pig and human aortic endothelial cells (AECs)
CD55 (DAF) CD141 (TBM)CD46
CD55 (DAF) CD141 (TBM)CD46
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GENETICALLY-ENGINEERED PIGS CURRENTLY AVAILABLE
Revivicor has produced pigs with 20 different genetic manipulations
Some pigs have 7 modifications
Worldwide, 40 different manipulations
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ELICITED ANTI-PIG ANTIBODIES
Unless prevented by
immunosuppressive therapy, after
exposure to a pig organ or cells,
anti-pig antibodies can increase
>10-fold
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PROGRESS IN PIG-TO-NHP KIDNEY TX
Progress in immunosuppressive therapy:Conventional (e.g., tacrolimus, steroids)Costimulation blockade(Genetically-engineered pigs)
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PROGRESS IN PIG-TO-NHP KIDNEY TX
The Emory group had one monkey surviving >10 months with a life-supporting pig kidney graft
(The NIH group had two baboons surviving >1 year after a heterotopic heart graft)
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PIG-TO-NHP RENAL XENOTX
GTKO/hDAF Rhesus macaque:
T cell depletion,
anti-CD154, MMF/steroids
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BARRIERS TO XENOTRANSPLANTATION
Immunologic PHYSIOLOGIC Safety (risk of infection) Ethical Regulatory / Legal
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B9313 - INCREASE IN SIZE OF KIDNEY
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BARRIERS TO XENOTRANSPLANTATION
Immunologic Physiologic SAFETY (RISK OF
INFECTION) Ethical Regulatory / Legal
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SAFETY OF XENOTRANSPLANTATION
Concern regarding potential transfer of infectious microorganisms to (1) recipient, (2) public
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SAFETY OF XENOTRANSPLANTATION
‘Remaining’ potential risk:
Porcine endogenous retroviruses (PERVs)
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BARRIERS TO XENOTRANSPLANTATION
Immunologic Physiologic Safety (risk of infection) ETHICAL REGULATORY / LEGAL
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GENETICALLY-ENGINEERED PIGS
1. No unacceptable implications for the health and welfare of the pig2. No serious ethical objections to the genetic procedure
- brain (pig or human)- reproduction of one species by
the otherThe Netherlands
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“There are many ways of losing money.
Women are the most fun. Gambling is the fastest. Research is the most certain.”
Lord HivesChairman of Rolls Royce
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GENETICALLY-ENGINEERED PIGS
Recent new technologies, e.g., Zinc finger nucleasesTALENSCRISPR/Cas9
will facilitate the production of pigs with multiple genetic modifications
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History tells us that procedures that were inconceivable yesterday, and are barely achievable today, often become routine tomorrow.
Thomas E. Starzl, 1982
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POTENTIAL ALTERNATIVES TO XENOTRANSPLANTATION
1. Human stem cells2. Regenerative medicine3. Cell-based mechanical devices
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FIRST CLINICAL TRIAL
? Patients highly-sensitized to alloantigens (high PRA)
? Patients with problems of vascular access for dialysis
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“It is often sufficient to know, in the large, that
a thing may be possible”
Littre, 1710Royal Academy of
ScienceParis
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One day “making a pig of yourself” could have a whole new meaning
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THANK YOU