Tissue Safety in View of CJD and Variant CJD
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Ó Springer 2005
Tissue safety in view of CJD and variant CJD Georg Pauli Center for Biological Safety, Robert Koch-Institut, Nordufer 20, 13353 Berlin, Germany; (e-mail: PauliG@ rki.de) Received 10 June 2005; accepted in revised form 23 June 2005
Key words: Creutzfeldt–Jakob disease, Diagnostic tests, Donor selection, Iatrogenic transmission, TSE
Abstract Epidemiological studies on human transmissible spongiform encephalopathies (Creutzfeldt–Jakob Disease, CJD) have shown that the agent could be transmitted by highly infectious tissues like brain, spinal cord or retina and medicinal products derived from these tissues (i.e. human growth hormone, dura mater). A few cases of transmission of CJD by neurosurgical instruments have been reported. The transmission of the agent of variant CJD, which is suspected to be transmitted by BSE-contaminated food, by blood transfusion implies that in contrast to the agent of classical CJD this agent can also be transmitted by organs and tissues other than nerve tissues. Health authorities have implemented guidelines to reduce the risk of transmission of human and animal TSE by human and veterinary medicinal products. The high resistance of TSE agents against physical or chemical treatment hamper the development of highly efficient inactivation steps in the production of medicinal products. Donor selection is considered as an efficient measure to reduce the risk of TSE transmission. However, the development of rapid, sensitive and specific diagnostic test systems is urgently required to test blood, organs and tissue of donors.
Introduction The medical application of organs, tissues or other medicinal products derived from human and/or animal tissue is steadily increasing. This includes implantable therapeutic devices, pharmaceutical products, homeopathic goods for topical preparations, biological reactants (e.g. enzymes, culture medium) used in the processing of therapeutic goods as well as those used in the laboratory as in vitro diagnostics. Organs and tissue derived from a single human cadaver donor are often transplanted to numerous recipients (e.g. lung, heart, kidneys, liver, cornea, cardiac valves, bone, tendon, skin, cartilage) and, if contaminated with infectious agents, can therefore transmit diseases to many recipients (Eastlund and Strong 2004). In case animal-derived material is used, the risk of
transmitting zoonotic pathogens has to be considered (Fishman 2001). By donor selection and donor screening for evidence of transmissible diseases it is possible to reduce the risk of pathogen transmission (Goodman 2004). This risk can be lowered further by introducing inactivation or elimination steps for viruses and bacteria into the production process whenever possible. However, inactivation steps can not be included in the production process of a variety of medicinal products, e.g. labile blood products or organ transplants. In these cases application of selection criteria and testing strategies for pathogens are the only means to reduce the infection risk of the recipients b
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