Management of clinical risks deriving from insertional mutagenesis

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Reflection paper

Reference numberCAT/190186/2012
Published01/08/2013
KeywordsGene therapy medicinal products, insertional mutagenesis, integration
DescriptionThis document discusses the factors contributing to genotoxicity of vector integration, the strategies to reduce the risk associated to insertional mutagenesis and the assays to evaluate vector oncogenesis at the pre-clinical and clinical level.


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