from ongoing clinical trials involving xenotransplants. To deal with these considerations:
Recommendation 4: The committee recommends that a mechanism be established within the Department of Health and Human Services to ensure needed coordination of the federal agencies and other entities involved in development, oversight, and evaluation of established guidelines.
At least one scientist who participated in the workshop believed that the risk of infectious disease transmission is high enough to preclude any further human xenotransplantation trials. After considerable discussion of this view and consideration of the issues listed above that will be required to assess the risk of infection, the committee concluded that the potential benefits of xenotransplants are great enough to justify this risk. Hence:
Recommendation 5: The committee recommends that, when the science base for specific types of xenotransplants is judged sufficient and the appropriate safeguards are in place, well-chosen human xenotransplantation trials using animal cells, tissues, and organs would be justified and should proceed.
Clinical trials with cellular xenotransplants are already under way, and a real danger exists that the commercial applications of xenotransplant technology will outstrip both the research base and the national capacity to address special issues raised by xenotransplantation, including the risk of disease transmission. The committee considered the total expense associated with research and technology development, especially in light of current fiscal restraints. Substantial, stable resources are needed to support research, such as virus discovery, better understanding of the physiology of transplanted organs, and mechanisms of rejection; to perform diverse, well-designed clinical trials; and to maintain patient registries, tissue and serum sample collections, and surveillance for disease in patient populations. The committee concludes that the potential of xenotransplantation is great enough to justify funding, by federal agencies, private industry, and other sources, of research and other programs (e.g., tissue banks and patient registries) necessary to minimize the risk of disease transmission.