Consensus statement on the bio-safety of urinary-derived gonadotrophins with respect to Creutzfeldt-Jakob disease.
نویسندگان
چکیده
Human transmissible spongiform encephalopathies (TSE) encompass a group of rare neurodegenerative diseases. In April 2004, a group of international experts and regulators met in Buenos Aires, Argentina, to review the safety and to reach consensus on the use of urinary-derived gonadotrophins with respect to TSE. Iatrogenic transmission of Creutzfeldt-Jakob Disease (CJD) from pituitary-derived gonadotrophins has been reported, no infectivity in urine has been demonstrated, and no definite cases of transmission via urine have been reported. It is currently not possible to monitor donor urine or finished product for the presence of prions. Therefore the assessment of risk has to be based on the likelihood of infection in urine, the source of the urine, and the capacity of the manufacturing process to remove any adventitious infection. Urine for the production of medicinal products should be obtained from sources that minimize the possible presence of materials derived from subjects suffering from human TSE. As no strong evidence for TSE infectivity in urine exists, it can be concluded that the risk of disease-generating prions and TSE infectivity being present in donor urine is low. Current evidence indicates that, with respect to the risk of TSE infection, urinary-derived gonadotrophins appear to be safe.
منابع مشابه
CHMP position statement on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products
This CHMP position statement replaces the CHMP position statement on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products (EMEA/CPMP/BWP/2879/02/rev 1). CHMP position statement on Creutzfeldt-Jakob disease and plasma-derived and urine-derived medicinal products
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1 Dyer C. Growth hormone victims seek compensation. BMJ 1993;306:607. (6 March.) 2 Pituitary hormones for infertility [editorial]. BMJ 1965;ii:316. 3 Crooke AC, Butt WR, Palmer RF, Morris R, Logan Edwards R, Anson CJ. Clinical trial of human gonadotrophins. Joumnal of Obstetrics and Gynaecology of the British Commonwealth 1963; 70:604-35. 4 Cochius JI, Hyman N, Esiri MM. Creutzfeldt-Jakob disea...
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عنوان ژورنال:
- Human reproduction
دوره 20 11 شماره
صفحات -
تاریخ انتشار 2005