Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
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The Wall Street Journal - 23 Sep 1996
Laurie McGinley, Staff Reporter of The Wall Street Journal
But while researchers welcomed the guidelines, some said their issuance isn't likely to lead to a surge of the rare procedures, known as xenotransplants, anytime soon. That's because scientists still face formidable problems involving the human body's rejection of animal parts, as well as infections and other complications, said John Fung, director of transplant surgery at the University of Pittsburgh Medical Center, where surgeons in 1992 performed the world's first baboon-to-human liver transplant.
The interest in animal-to-human transplants stems primarily from the severe shortage of human organs. About 48,000 people are on the waiting list for organs, and about 3,000 people die each year because donor organs aren't available. Much of the debate surrounding the use of animal parts concerns the possibility of transmitting an infectious disease from the animal donor to the human. But the Institute of Medicine, which operates under the auspices of the National Academy of Sciences, recently concluded that the benefits of xenotransplants outweigh the risks.
The best-known case occurred in December 1995 when AIDS patient Jeff Getty received bone marrow from a baboon. Elsewhere, researchers are experimenting with implanting fetal pig cells in patients with Parkinson's Disease and calf cells in the spinal cord of terminal cancer patients to relieve pain.
The proposed guidelines, developed by the FDA, the Centers for Disease Control and Prevention, and the National Institutes of Health, are intended to make it clear to researchers what the government requires in animal-to-human transplants, which are regulated by the FDA. Public comment will be received for 90 days.
The proposed guidelines recommend that researchers take safety measures to minimize the possibility of cross-species transmission of diseases; select members of the xenotransplant team for their expertise in infectious diseases and animal health; receive approval from local hospital review boards; and monitor patients after the transplants for latent animal organisms that may cause diseases in humans.
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