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PHS Guideline on Infectious Disease Issues in Xenotransplantation PHS Guideline January 2001

Docket Number:
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
OMB Control No. 0910-0456
Expiration Date:  06/30/2025

Several developments have fueled the renewed interest in xenotransplantation- the use of live animal cells, tissues and organs in the treatment or mitigation of human disease.  The world-wide, critical shortage of human organs available for transplantation and advances in genetic engineering and in the immunology and biology of organ/tissue rejection have renewed scientists' interest in investigating xenotransplantation as a potentially promising means to treat a wide range of human disorders.  This situation is highlighted by the fact that in the United States alone, 13 patients die each day waiting to receive a life-saving transplant to replace a diseased vital organ.

While animal organs are proposed as an investigational alternative to human organ transplantation, xenotransplantation is also being used in the effort to treat diseases for which human organ allotransplants are not traditional therapies (e.g., epilepsy, chronic intractable pain syndromes, insulin dependent diabetes mellitus and degenerative neurologic diseases such as Parkinson's disease and Huntington 's disease).  At present, the majority of clinical xenotransplantation procedures utilize avascular cells or tissues rather than solid organs in large part due to the immunologic barriers that the human host presents to vascularized xenotransplantation products.  However, with recent scientific advances, xenotransplantation is viewed by many researchers as having the potential for treating not only end-organ failure but also chronic debilitating diseases that affect major segments of the world population.


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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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All written comments should be identified with this document's docket number: 96M-0311.


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