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Subject: DURA MATER-ASSOCIATED CJD: FIRST REPORTED CASE FROM PORCINE SOURCE DURA
Date: April 19, 2006 at 4:56 pm PST

SHORT REPORT

Dura mater-associated Creutzfeldt–Jakob disease:

experience from surveillance in the UK


C A Heath, R A Barker, T F G Esmonde, P Harvey, R Roberts, P Trend, MWHead, C Smith, J E Bell,

J W Ironside, R G Will, R S G Knight

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

J Neurol Neurosurg Psychiatry 2006;000:1–4. doi: 10.1136/jnnp.2005.073395

Between 1970 and 2003, seven cases of human dura materassociated

Creutzfeldt–Jakob disease (CJD) were identified in

the UK. Furthermore, we identified a case of CJD in a porcine

dura graft recipient. The mean incubation period of the

human dura mater cases was 93 (range 45–177) months.

The clinico-pathological features of the cases are described

and compared with cases previously reported in the world

literature.

Creutzfeldt–Jakob disease (CJD) exists in four clinical

forms: sporadic, genetic, iatrogenic and variant. The

cause of sporadic CJD, the most common form worldwide,

is unknown and case–control studies have failed to

identify any consistent risk factor, although two studies have

implicated previous surgical interventions.1 2 Genetic forms of

the disease are associated with underlying mutations of the

prion protein gene (PRNP), which are generally considered to

be directly causative.Mutations, however, possibly increase

liability to some, as of yet unrecognised, source of infection.

The two remaining forms of CJD are acquired. Variant CJD is

considered to be caused by bovine spongiform encephalopathy,

3–5 through contaminated food products; iatrogenic CJD

results from the inadvertent transmission of CJD during the

course of medical or surgical treatment. The two most

numerically significant instances of iatrogenic CJD resulted

from treatment with cadaveric human growth hormone and

the use of dura mater grafts in surgery. Corneal grafts, depth

electrodes and neurosurgical instruments have also rarely

been implicated.6 7

The first report of dura mater-associated CJD was

published in 1987,8 with a more detailed report appearing

the following year;9 to date, 164 cases have been recognised

worldwide (P Brown, personal communication) ; . This paper

reports and describes the seven cases of human dura mater

graft-associated CJD identified during surveillance in the UK

and also, for the first time, reports a case of CJD in a porcine

dura graft recipient.

METHODS


snip...see full text;

http://press.psprings.co.uk/jnnp/may/jn73395.pdf



Subject: Re: DURA MATER-ASSOCIATED CJD: FIRST REPORTED CASE FROM PORCINE
SOURCE DURA
Date: April 19, 2006 at 7:12 pm PST

Daily Dockets - 04/10/03

... 00D-1662 Use of Xenotransplantation Products in Humans.
EMC 98 Terry S. Singeltary Sr. Vol#: 3. 01F ...

http://www.fda.gov/ohrms/dockets/dailys/03/Apr03/041003/041003.htm

-05-20-2003


Subject: RE--[Docket No. 00D-1662] Xenotransplantation Products and
HUMAN/ANIMAL TSEs ''SUBMISSION''
Date: Mon, 07 Apr 2003 12:01:01 -0500
From: "Terry S. Singeltary Sr."
To: [email protected]

IN regards to [Docket No. 00D-1662], i would
kindly like to make several further comments regarding
human/animal TSEs. my comments will be posted below the
snips of concern i have posted from [Docket No. 00D-1662]
Xenotransplantation Products and HUMAN/ANIMAL TSEs;

[Federal Register: April 4, 2003 (Volume 68, Number 65)]
[Notices]
[Page 16542-16543]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ap03-84]


snip...


WITH ALL these factors, then add in the potential for not only
BSE/TSEs in USA cattle, but also the potential that CWD and
Scrapie could be transmitted to man, and what potential risks
these could pose via the medical/surgical/Xenotransplantation
arena, and then to think of surgical tools that would be used
in these Xenotransplantation and the _other_ humans they may be
used on LATER, with even possibly 2nd and 3rd passage of TSEs.
Serious thought and very critical precautions should be taken
before such Xenotransplantation take place, with regard to
human/animal Transmissible Spongiform Encephalopathies...

thank you,

i am sincerely,
Terry S. Singeltary Sr.
P.O. Box 42
Bacliff, Texas USA 77518
CJD WATCH


Research Project: Transmission, Differentiation, and Pathobiology of
Transmissible Spongiform Encephalopathies

Location: Virus and Prion Diseases of Livestock

Title: Evaluation of a Diet Free of Animal Protein in Germfree Swine

Authors
item Loynachan, A - IOWA STATE UNIVERSITY
item Pettigrew, J - UNIVERSITY OF ILLINOIS
item Wiseman, B - NEXTRAN, INC
item Kunkle, Robert
item Harris, D - IOWA STATE UNIVERSITY

Submitted to: Xenotransplantation
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: January 5, 2005
Publication Date: March 1, 2005
Citation: Loynachan, A.T., Pettigrew, J.E., Wiseman, B.S., Kunkle, R.A.,
Harris, D.L. 2005. Evaluation of a Diet Free of Animal Protein in Germfree
Swine. Xenotransplantation. 12:149-155.

Interpretive Summary: Basic research into the potential to use organs
harvested from swine for the purpose of transplantation to save human lives
has identified potential immunological and transmissible infectious disease
obstacles. BSE has been transmitted to swine following intracerebellar
inoculation, indicating the potential susceptibility of pigs to prion
infections. Although neither natural nor experimental oral transmission of
spongiform encephalopathies has been recorded in pigs, concerns about the
transmission of prion proteins in feed have led to the development of a diet
free of animal protein (DFAP). This study describes a method to rear
neonatal pigs in a manner that precludes exposure to environmental
microorganisms and animal-derived proteins. Twenty pigs were derived by
Cesarian-section and housed in sterile bubble-pens. Duplicate trials were
conducted in which germ-free pigs or pigs intentionally colonized exclusivel
y with the bacterium Lactobacillus paracasei subspecies paracasei were fed
either a traditional milk-based diet (Esbilac) or the experimental DFAP. On
the whole, the pigs in all groups remained healthy, however, two pigs fed
the DFAP developed mild diarrhea and gained less weight. The pigs were
euthanized at 16 days of age. Examinations revealed no evidence of
contamination or disease. The use of the probiotic, Lactobacillus paracasei,
did not confer any measurable growth advantage to pigs fed either diet. The
experimental DFAP was capable of sustaining life, but was not as efficacious
as the conventional milk-based diet as based upon weight gain and
feed-conversion.

Technical Abstract: Two experiments were conducted in which germfree pigs or
pigs monoassociated with Lactobacillus paracasei subspecies paracasei were
fed either a traditional milk-based diet (Esbilac) or an experimental diet
free of animal protein (DFAP). Throughout the 16-day study, animals' general
disposition, total weight gain, feed conversion, and bacterial contamination
were monitored. At the conclusion of the study the animals were euthanized,
necropsied and tissues sampled for L. paracasei isolation. General pig
disposition remained consistent between treatment groups and trials, except
for two animals that developed mild diarrhea during trial 1. All pigs
remained viable during the study irrespective of the diet fed or probiotic
inoculation. Germfree pigs fed the Esbilac diet gained on average a total of
1034 (+/- 63.0) g, and had a feed conversion ratio of 0.17 (+/- 0.01) g of
gain per 1 ml of diet. Germfree pigs fed the experimental diet gained on
average a total of 599 (+/- 151) g, and had a feed conversion ratio of 0.10
(+/- .02) g of gain per 1 ml of diet. Monoassociated pigs fed the Esbilac
diet gained on average a total of 862 (+ 70.3) g, and had a feed conversion
ratio of 0.14 (+/- 0.01) g of gain per 1 ml of diet. Monoassociated pigs fed
the experimental diet gained on average a total of 563 (+/- 96.8) g, and had
a feed conversion ratio of 0.09 (+/- 0.02) g of gain per 1 ml of diet. L.
paracasei established extensively in pigs fed either the Esbilac or
experimental diets. L. paracasei had no effect (p>0.05) on piglet growth and
did not display any interactions based on the diet fed. Statistical
differences (p<0.05) were noted on measured growth parameters between trial
1 and 2, and on measured growth parameters based on the diet fed. In
conclusion, a diet free of animal protein has been developed and has been
shown to be capable of sustaining life in piglets up to 16 days of age.


http://www.ars.usda.gov/research/publications/publications.htm?SEQ_NO_115=170002


You should obtain source animals from TSE-susceptible species only from
closed herds that are documented to be free from TSE diseases or
TSE-associated agents (see also section III.C.3.c.). You should not use
source animals obtained from geographic areas in which TSEs are known to
exist in the source species. In the application to FDA requesting
investigational use of the xenotransplantation product (e.g., IND), you
should describe and justify the frequency of the screening, the method
of assay, and the method of identifying which and what proportion of
animals are sampled. As data are accumulated that demonstrate product
safety, you may modify the screening program in consultation with the FDA.

2. Animal History

snip...

iii. It should include any known time course for the risks of disease
development and transmission. It should discuss infectious diseases with
protracted incubation periods including TSEs and other unusual pathogens.

http://www.fda.gov/cber/gdlns/clinxeno.htm#iii


snip...

``Guidance for Industry: Source Animal, Product, Preclinical, and
Clinical Issues Concerning the Use of Xenotransplantation Products in
Humans;'' Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-8167.htm



USA TISSUE DONOR HERDS???

Subject: BSE--U.S. 50 STATE CONFERENCE CALL Jan. 9, 2001
Date: Tue, 9 Jan 2001 16:49:00 -0800
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L


Greetings List Members,

I was lucky enough to sit in on this BSE conference
call today and even managed to ask a question.
that is when the trouble started.

I submitted a version of my notes to
Sandra Blakeslee of the New York Times,
whom seemed very upset, and rightly
so.

"They tell me it is a closed meeting and
they will release whatever information
they deem fit. Rather infuriating."

and i would have been doing just fine,
until i asked my question. i was surprised
my time to ask a question so quick.

(understand, these are taken from my notes for now.
the spelling of names and such could be off.)

[host Richard Barns]
and now a question from Terry S. Singeltary of
CJD Watch.

[TSS]
yes, thank you,
U.S. cattle, what kind of guarantee can you
give for serum or tissue donor herds?

[no answer, you could hear in the back ground,
mumbling and 'we can't. have him ask the question
again.]

[host Richard]
could you repeat the question?

[TSS]
U.S. cattle, what kind of guarantee can you
give for serum or tissue donor herds?

[not sure whom ask this]
what group are you with?

[TSS]
CJD Watch, my Mom died from hvCJD and we are
tracking CJD world-wide.

[not sure who is speaking]
could you please disconnect Mr. Singeltary

[TSS]
you are not going to answer my question?

[not sure whom speaking]
NO

from this point, i was still connected, got to listen
and tape the whole conference. at one point someone
came on, a woman, and ask again;

snip...end

TSS
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