PRO/AH> Xenotransplantion, new federal guidelines - USA

jon allan jallan at icarus.sfbr.org
Tue Nov 12 15:14:10 EST 1996


XENOTRANSPLANTATION, NEW FEDERAL GUIDELINES - USA 
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[See also: Xenografts & primate viruses    get promed-1995 950228]

Date: Thu, 7 Nov 1996 11:57:33 -0500
From: jallan at icarus.sfbr.org (jon allan)


Recently, the federal guidelines for xenotransplantation were published in
the federal register. You can access this document in several ways;

1. http://www.fda.gov/cber/cberftp.html
2. bounce back email,  Xeno at al.cber.fda.gov
3. by fax by calling 1-888-CBER-FAX or 301-827-3844.

There is a 90 day period for submitting comments, which ends on December
23, 1996.

There are several questions that need to be visited (revisited) regarding
the infectious disease risks associated with animal-to-human
transplantation.

1. Is there a reason to believe that baboons harbor viruses that could be
pathogenic in humans?

2. Are there any procedures that sufficiently reduce the possibility of a
new emerging infectious disease being established in humans? And do we have
the technology available to screen for agents that we have yet to recognize
exist in baboons? This is especially important for viruses that cause
little or no disease in their natural host species (immunodeficiency
viruses, herpesviruses) and which have long latency periods that would not
be detected with quarantine procedures.

3. Should we restrict xenotransplantation to swine [organs]? As a cost:benefit
analysis, if swine organs can be transplanted successfully, the numbers of
SPF animals are likely to meet the needs of human recipients. The baboon
resource is small and difficult to produce. Should we ban the use of
baboons, proceed knowing that it is virtually guaranteed that a virus will
be transmitted to a human recipient, or let the transplant community decide
what it needs?

4. What are the real vs. preceived benefits from baboon to human
transplants?
Can baboon bone marrow be a cure for AIDS? Are there enough baboons or can
we raise enough to help with the shortage of human organs? Baboon
transplantation is being proposed as a bridge for infants with heart
defects that are too young to qualify for a human heart.

5. Are the current draft guidelines likely to significantly reduce the
possibility of transmitting a new infectious agent into humans?

6. Should there be more emphasis on regulating this procedure? Currently,
most of the responsibility for decisions regarding both baboon and swine
transplants lie with the transplant team and the local institutional review
boards. Or should we regulate this technology in much the same manner as we
regulate other procedures such as monoclonal antibody therapies and gene
therapy?

In the end, I believe that an open discussion of xenotransplantation in
regard to the infectious disease risks is long overdue. To date, the
transplant community has weighed in heavily in favor of using each of these
animal donors.  However, the virology community has been conspicuously absent
-- or are we to believe that most virologist consider using baboons safe?

References:
-----------
Allan, J.S. (1994) Primates and New Viruses.  Science (Letter) 265:1345-6.
Allan, J.S. (1996) (commentary) Xenotransplantation: Prevention versus
Progress. Nature Medicine 2:18-21
Allan, J.S. (1995) Xenograft transplantation and the infectious disease
conundrum. ILAR J. 37:37-48.
Allan, J.S. and Michaels, M. (1995) Xenotransplantation: concerns aired
over potential new infections. ASM News 61(9): 442-443.
Allan, J.S. (1996) Xenotransplantation and Possible Emerging Infectious
Diseases. Molecular Diagnosis 1(3):  1-8.
Steele D, Auchincloss H: The application of xenotransplantation in humans-
reasons to delay. ILAR J 1995;37:13-15.
Reemstma K: Xenotransplantation:historical perspective. ILAR J
1995;37:9-12.
Michler R: Xenotransplantation: risks, clinical potential and future
prospects. Emerg Inf Dis 1996;2:64-70.
Thompson C: No cheers for baboon to AIDS patient xenotransplant. Lancet
1995;346:369-370.
Fishman J: Miniature swine as organ donors for man: strategies for
prevention of xenotransplantation-associated infections.
Xenotransplantation 1994;1:47-57.
Michaels M, Simmons R: Xenotransplant-associated zoonoses. Transplantation
1994;57:1-7.
Stoye J, Coffin J: The dangers of xenotransplantation. Nat Med
1995;1(11):1100.
Smith D: Endogenous retroviruses in xenografts. Lancet 1993;328:142-143.
Duncan R, Murphy R, Mirkovic R: Characterization of a novel
syncytium-inducing baboon reovirus. Virology 1995;212:752-756.
Chapman L, Folks T, Salomon D, Patterson A, Eggerman T, Noguchi P:
Xenotransplantation and xenogeneic infections. New Engl J Med 1995;
333:1498-501.
Plagemann P: Virus infection of baboons. Nature 1995;377:98.
Nuffield Council on Bioethics. Animal-to-human Transplants, the ethics of
xenotransplantation. 1996.
Grant R, Windsor S, Malinak C, Bartz C, Sabo A, Benveniste R, Tsai C:
Characterization of infectious type D retrovirus from baboons. Virology
1995;207:292-296.
Allan J, Ray P, Broussard S, Whitehead E, Hubbard G, Butler T, Brasky K,
Luciw P, Cheng-Mayer C, Levy J, Steimer K, Li J, Sodroski J, Garcia-Moll M:
Infection of baboons with human and simian/human immunodeficiency viruses.
JAIDS and Human Retrovirology 1995;9:429-441.
Mone J, Whitehead E, Leland M, Hubbard G, Allan JS: Simian T-cell leukemia
virus type 1 infection in captive baboons.  AIDS Res Human Retroviruses
1992;8(9):1667-1675.

--
Jon Allan, DVM
Dept. of Virology and Immunology
Southwest Foundation for Biomedical Research
7620 N.W. Loop 410 at Military Drive
San Antonio, Texas 78023
phone 1(210) 670-3275
fax 1(210) 670-3332
Email: jallan at icarus.sfbr.org
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