Tissue safety in view of CJD and variant CJD.

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.