Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
Food and Drug Administration, U.S. Department of Health and Human Services - September 20, 1996
Lenore Gelb; (301) 443-3285
The recommended procedures announced in the Federal Register today were developed collaboratively by the Food and Drug Administration, the Centers for Disease Control and Prevention, and the National Institutes of Health.
"This guideline represents the consensus of physicians and scientists regarding the best way to move ahead in the field of xenotransplantation," said HHS Secretary Donna E. Shalala. "Today we are offering it for review and comment by the scientific and medical community and the public."
"This guidance is aimed at achieving the right balance. We want to protect the public and patients from potential risks while not impeding research into these promising new treatments," said Commissioner of Food and Drugs David A. Kessler, M.D.
The guideline covers all forms of xenotransplantation, including experiments with unmodified solid organs and is based on a series of public meetings that FDA, CDC, and NIH held with members of the medical and scientific community, academia, and the general public.
To help safeguard the public health, the recommendations include:
* Taking appropriate safety measures for pre-transplant animal screening to minimize the possibility of cross-species transmission of animal diseases, also known as zoonoses;
* Archiving biologic samples (including sera, plasma, leukocytes, and tissues) from the source animal and transplant recipient for potential public health investigations;
* Selecting members of the xenotransplant team for their expertise in providing adequate safeguards and conducting research that will yield useful data;
* Having local review boards evaluate the operations to assess infectious disease risks; and
* Monitoring patients after xenotransplants for infectious agents, including not yet recognized, or latent animal organisms which may cause diseases in humans, especially patients who are immunocompromised.
In addition to the guideline, HHS will create a national registry to provide a centralized database for public health research and investigations. The FDA, CDC, and NIH are collaborating with the Health Resources and Services Administration (HRSA) to develop a pilot program for the registry.
Limited availability of human organs and tissues, coupled with recent biotechnical advances, has increasingly led to implantations of living cells from other species when human donors are not available, when a bridge organ is needed, or when animal cells may provide a unique benefit.
These xenotransplant products are regulated by FDA as biologics under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act. Clinical studies of new experimental products, such as xenogeneic cells, tissues, and organs, should be performed under an Investigational New Drug (IND) application that is filed with the FDA. IND applications should contain sufficient information to ensure that trial subjects will not be exposed to unreasonable risks based on the potential for benefit.
The Public Health Service seeks public comments on the guideline for 90 days following its release. The guideline will be available directly from FDA as well as from FDA's home page on the Internet World Wide Web (www.fda.gov).
The revised document will be published in CDC's Morbidity and Mortality Weekly Report as well as the NIH Guide for Grants and Contracts and the Federal Register later in the year. It may be updated periodically based on new scientific and medical information about xenotransplantation.
FDA will soon publish a draft guidance document to provide further practical information to the transplant community.
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SOURCE: Food and Drug Administration (FDA).
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