EMA Position Statement on Creutzfeldt-Jakob Disease and advanced Therapy medicinal Products

In June 2011, the CHMP/CAT position statement on Creutzfeldt-Jakob disease and advanced therapy medicinal products was agreed by the Biologics Working Party and adopted by the CHMP/CAT.
In the European regulation "advanced therapy medicinal products (ATMP)" include those based on gene therapy, cell therapy and tissue engineering. Although they are considered biological medicinal products as described in the directive 2001/83/EC, specific legislation has also been developed (Regulation (EC) no 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products). The composition of ATMPs may include components of human origin (either as active ingredient, excipients, or raw materials used in their manufacture) and, therefore, the risk of transmitting CJD or vCJD agents has to be considered.
This document lists the current guidelines for minimising the transmission risk via gene therapy products, cell therapy and tissue engineering products as well as blood and plasma based medicinal products. Furthermore, it lists all documents and guidelines which offer valuable clues to the exclusion criteria for donors related to risk of transmission of diseases caused by prions.

Related to the collection and storage of cells from umbilical cords the position paper assesses:
"The collection and storage of cells from umbilical cords is becoming increasingly common in both allogeneic and autologous transplantation in children and adults. These cells are of foetal origin but the possibility of low levels of contamination with maternal blood can not be definitively excluded. However, the likelihood of infection is considered as extremely low, since vertical transmission in humans has not been observed in any prion disease."

Please also read the complete position statement.

Axel H. Schroeder
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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