After several years of study, the government has published its guideline on xenotransplantation.
The Department of Health and Human Services (HHS) first issued the draft Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation in September 1996, and the guideline has been revised to reflect comments on the draft, advances in science, and international policy discussions. HHS said the revised draft would be formally issued following a comment period.
According to HHS, the guideline provides for a thorough review of plans for xenotransplantation clinical trials; a thorough informed consent process for patients and their families; life-long medical follow-up of patients; rigorous safety standards for animal cells, tissues, and organs; laboratory testing to identify known and novel infectious agents; and a pilot database of information on xenotransplantation clinical trials. "HHS has modified the federal government's definition of xenotransplantation as follows: 'the implantation or infusion into a human recipient of either (a) live cells, tissues or organs from a nonhuman animal source or (b) human body fluids, cells, tissues or organs that have had ex-vivo (external) contact with live nonhuman animal cells, tissues or organs.' The use of non-living, processed biological products or materials from animals such as pig heart valves and pig insulin, which has been in practice for decades, is not classified as xenotransplantation," HHS said in a fact sheet.
HHS acknowledged that the "principal concern" with xenotransplantation has been the possibility of infecting patients with infectious agents transmitted from animals, but the agency cited three studies in which animal infectious agents were not transmitted to the human recipients of xenotransplantation products.
For Your Information:
HHS posts its fact sheet at www.hhs.gov/news/press/2000pres/20000526.html, which contains a link to a statement (http://www.fda.gov/cber/xap/xap.htm) on the Food and Drug Administration website. This statement, in turn, provides a link to the actual guideline (http://www.fda.gov/cber/gdlns/xeno0500.txt) and a variety of related documents.
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