Guidelines proposed for animal-man transplants Rules respond to concern about potential for new and known diseases


Federal health officials yesterday proposed new guidelines for transplants of animal organs and tissues into humans, responding to concerns about their potential for causing outbreaks of new and previously known diseases.

The guidelines "aim to walk a tightrope" in protecting public health while not impeding promising research efforts to find new ways to alleviate the shortage of human donor organs and tissues, said Dr. David A. Kessler, the commissioner of the Food and Drug Administration.

The need for the guidelines reflects recent successes with human transplants. About 48,000 Americans are on waiting lists for human organ transplants and about 3,000 die each year because they cannot receive a transplant in time.

The success, in turn, has led immunologists and surgeons to renew efforts to overcome the immune reaction by which humans naturally reject animal tissue.

The guidelines for cross-species transplants were developed by the Food and Drug Administration, the National Institutes of Health and the Centers for Disease Control and Prevention, and are generally in accord with versions presented at several earlier scientific meetings. The guidelines are being published in the Federal Register and the public will have 90 days to comment.

The guidelines for the use of animal tissues in humans, which is known as xenotransplantation, will cover all forms of xenotransplants, including cells, tissues and organs.

In a widely publicized case last year, an AIDS patient, Jeff Getty, received bone marrow cells from a baboon in an experiment in San Francisco in the hope that the baboon's cells, which are resistant to infection with the AIDS virus, would improve his health. Although the baboon cells did not take hold in Getty, he is thriving and his doctors can't explain why.

Among other potential uses of xenotransplants are these:

Insulin-producing pancreatic cells from pigs for diabetics.

Fetal pig cells for treating Parkinson's disease.

A genetically modified pig liver for treating the most severe form of liver failure.

Implanting cells from the adrenal glands of fetal calves to relieve pain in late stages of cancer.

"We must realize up front that we are dealing with many unknowns" in xenotransplantation, Kessler said.

The guidelines recommend but do not require creation of a national registry to provide information to help identify xenotransplant-associated problems.

Federal officials are calling for researchers conducting xenotransplants to document an animal's breeding history and to take appropriate safety measures to screen animals before using their tissues to reduce the chances of transmission of animal diseases. The guidelines call for local review boards to assess infectious disease risks.

Pub Date: 9/21/96

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