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1. Setting the Stage
Pages 6-16

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From page 6...
... In late 1963 and early 1964, a team at Tulane University led by Keith Reemtsma transplanted kidneys from chimpanzees into six patients, one of whom lived for nine months. By 1974, including experimental surgeries performed by Thomas Starzl at the University of Pittsburgh, about 20 patients had received xenotransplants.
From page 7...
... , improved understanding of graft rejection, and continuing organ shortages were major factors in more recent xenotransplant trials in the United States. In 1985, at Loma Linda University, Leonard Bailey implanted a baboon heart into Baby Fae, a newborn infant who survived four weeks.
From page 8...
... This report is based on the deliberations of an expert committee convened by the Institute of Medicine. The committee included clinicians, transplant surgeons, immunologists, specialists in infectious diseases, and social scientists with expertise in health services research, ethics, sociology, and law.
From page 9...
... Although the audience for this report is likely to be broad, the committee hopes it will be particularly useful to members of institutional review boards and institutional animal care and use committees that are considering proposals for human trials of xenotransplantation and to policymakers who are charged to participate in the coordination of efforts of the multiple federal agencies involved in xenotransplantation. The report is organized into five chapters.
From page 10...
... According to the United Network for Organ Sharing (UNOS) , in 1993 about 33,000 patients who needed organs were on the waiting list;2 whereas only 20nce a patient is placed on a waiting list, organ allocation proceeds according to criteria adopted by the board of UNOS after extensive public participation.
From page 11...
... Although other technologies have been developed to assist patients waiting for organs, none of these achieves optimal results and, often, none is sufficient to prevent death if an organ does not become available. For example, kidney transplant candidates have two options kidney dialysis and the possibility of receiving a kidney from a living donor.
From page 12...
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From page 13...
... After the passage of NOTA, the solution to the organ shortage was first thought to reside with increased public education. It seems, however, that public education does not increase the donation rate significantly, because donation has remained fairly stable over time, despite educational efforts and a requirement in more than 25 states for physicians to request organ donation from families of suitable donors.
From page 14...
... The proposal was to inject baboon bone marrow cells (known to be resistant to the human immunodeficiency virus that causes AIDS) into a person with AIDS in San Francisco.
From page 15...
... One tentative answer generated before this report was completed derives from approval of the much-publicized trial to use baboon bone marrow cells to treat AIDS. This approval, with numerous special requirements for disease surveillance, was given by the Food and Drug Administration after approval from the Institutional Review Board and the Laboratory Animal Care and Use Committee at the University of California, San Francisco.
From page 16...
... Still others are concerned that clinical practice may forge ahead despite the absence of an adequate scientific base, which happened, for example, with in vitro fertilization.4 In addition to the adverse effects of immunosuppression and the vascular damage that can accompany allotransplantation, there are risks that xenotransplantation may have negative effects on the quality of life of recipients, despite providing a medically effective outcome. There is also uncertainty about the eventual expense of xenotransplantation a complex issue that will be a critical determinant of the extent of eventual use of various types of xenotransplantation and must be considered in light of any eventual savings (e.g., decreased health care expenditures for diabetics with xenotransplants of pancreatic islet cells; also see Chapter 4~.


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