Brain Grafts Could Pass Disease (http://more.abcnews.go.com/sections/living/cjd

[Guest guest]

Wary of Creutzfeld-Jakob

Limiting Brain Grafts

For decades doctors have substituted brain tissue from cadavers for

tissues lost to trauma or tumor removal.

Manufacturers use gelatin from cattle in cosmetics, food and

pharmaceuticals. The European Union has banned the import of gelatin that may

contain nuerological tissues.

Only one U.S. brain graft has a link to a confirmed CJD case.

B E T H E S D A, Md., Oct. 6 — Strict steps must be taken to

ensure that people given brain tissue transplants during brain surgery do not

get fatal, brain-wasting Creutzfeldt-Jakob disease.

A U.S. health panel issued that stern warning Monday.

The advisory panel of the Food and Drug Administration included

Stanley Prusiner, the University of California neurology professor who won the

Nobel Prize in medicine Monday for discovering prion proteins, which are thought

to cause CJD and its cousins mad cow disease and scrapie in sheep.

Prusiner learned of the prize while in Bethesda for a meeting

of the group.

Dura May Hide Prions

The advisers said human brain transplant tissue—specifically, the

tough outer covering known as the dura mater—could carry the infective prions.

" No dura should be used in this country without these criteria

being fulfilled, " said panel chairman Brown, medical director of the

National Institute of Neurological Disorders and Stroke, referring to the

controls it recommended.

Half the panel said there are no surgical procedures in which

there's an absolute need for human grafts, and synthetic alternatives should be

considered.

" I don't think I've learned anything today that minimizes my

concerns, " said panelist Sidney Wolfe, director of the Public Citizen Health

Research Group.

Tissues from the Dead

Brain tissue from cadavers has been used for decades to replace

tissue damaged by trauma or tumor removal. But mounting evidence suggests that

some cases of " sporadic " CJD, which usually affects one in a million people, are

transmitted from infected animal or human tissue.

The FDA asked advisers if there was a need for stricter

safeguards or even an outright ban on human brain tissue grafts to minimize CJD

risk.

The panel recommended that donors be interviewed in depth about

family history of CJD and that all donor tissue be biopsied and tested for prion

proteins.

But it did not recommend a ban. Human grafts " have to be made

available, " Roos of the University of Chicago said.

There has only been one confirmed U.S. case of CJD linked to a

brain graft, in 1987.

It led the FDA to order manufacturers to decontaminate grafts.

The best-known method is bathing the tissue in sodium hydroxide, but it is not

known to be foolproof.

Scientists believe the infectious material is highly

concentrated in brain and spinal tissue.

Care Guidelines vs. Infection

" In my opinion, if there is a failure (to follow strict guidelines),

then use of this material would result in disease, " Will of the National

CJD Surveillance Unit in Edinburgh said. He said Britain had urged neurosurgeons

to use synthetic brain grafts, believing human grafts to be too risky.

Japan banned the use of human brain tissue implants in March

after long-term data indicated that one manufacturer's brain graft, called

Lyodura, probably caused 46 cases of CJD.

Also in March, the World Health Organization recommended that

use of human brain grafts be prohibited.

Synthetic substitutes made of Gore-Tex, polyester and other

materials are available, but not much is known about their longevity or

reactions in the body.

The FDA has already banned the use of animal tissue in animal

feed, and on Tuesday it will propose requiring gelatin manufacturers to take

more precautions.

No Room for Gelatin

Gelatin is used in cosmetics, food and pharmaceuticals. The European

Union has banned imports of foods, feeds, cosmetics and drugs that contain

neurological tissue from sheep, cattle and goats.

FDA advisers will also consider Tuesday whether human blood and

plasma pose a risk of CJD transmission.

CJD has been shown to be infectious. Children who received

injections of human growth hormone from the brains of cadavers, some of them

infected with CJD, developed the deadly disease themselves. Synthetic hormones

are now used instead.

Copyright 1997 Reuters. All rights reserved. This material may not

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