WASHINGTON _ Long-anticipated federal guidelines for thetransplantation of animal organs into humans were released onFriday. The proposed guidelines _ issued jointly by the FDA,National Institutes of Health (NIH) in Bethesda, Md. and the Centersfor Disease Control and Prevention (CDC) in Atlanta _ outlinesafeguards that medical researchers should employ in order toprevent the interspecies transfer of disease duringxenotransplantation.
"It's good that the guidelines are out because it gives all of theframework to start discussing these issues," said John Logan, vicepresident of research and development at Nextran in Princeton, N.J."For the industry, it's good to get these out now because people arejust beginning to enter the clinic."
As the supply of human organs for transplant continues to lag farbehind demand, researchers look increasingly to xenotransplants as ameans to ameliorate the severe shortage of organs. Every year anaverage of 4,835 people donate organs after death. However,approximately 48,000 people now are on the waiting list for organs.And, each year 3,000 die. As a result, several companies aredeveloping xenotransplant methods to stem rejection problemsassociated with animal to human transplants. (See BioWorld Today,Aug. 7, 1996, p. 1.)
As critical as rejection issues are to successful xenotransplantation,infection issues cast an even greater shadow on the success of suchtransplants. Because some viruses can innocuously infect one species,but wreak deadly havoc on others, federal regulators and infectiousdisease experts have been particularly concerned about the advent ofxenotransplantation. For example, concerns about foamy virus, adisease thought to be fatal in humans, were raised prior to AIDSactivist Jeff Getty's baboon-to-human bone marrow transplant. (SeeBioWorld Today, Dec. 1, 1995, p. 1.)
As a result of such concerns the Institute of Medicine, part of theNational Academy of Sciences in Washington, issued a report onxenotransplantation in July 1996 calling for national guidelines.
In order to minimize any cross-species disease transfer, the proposedPublic Health Service guidelines recommend that transplant teamsinclude specialists in infection control and clinical microbiology inaddition to surgeons and veterinarians. They also suggest that allprotocols pass review from the local Institutional Review Board andinclude an informed consent that discloses risks to the recipient andtheir close contacts.
The guidelines advise that animals be closely screened and thatresearchers bank serum and tissue samples from both animal donorsand human recipients. Under the guidelines, human recipients wouldneed to be monitored for animal diseases.
"No one should be too surprised with the draft guidelines, andcertainly we have thought about these issues," Logan said. "I will beinterested to see what comments come out of this. I think its a prettygood first draft."
The guidelines have entered into the 90-day public comment periodafter which the finalized document will be published in the CDC'sMorbidity and Mortality Weekly Report, the NIH's Guide for Grantsand Contracts, and the Federal Register. n
-- Lisa Seachrist Washington Editor
(c) 1997 American Health Consultants. All rights reserved.