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Meta-Analysis and Optimization of the In Vitro Immortalization Assay for Safety Assessment of Retroviral Vectors in Gene Therapy

9 Apr 2025

Abstract excerpt

The underlying risk of retroviral vector-induced insertional oncogenesis in gene therapies requires a reliable preclinical safety assessment. Dysregulation of genes neighboring the vector’s integration sites has triggered hematopoietic malignancies in patients treated with different vector genera and designs. With ca. 18 years in practical use, the in vitro immortalization (IVIM) assay can quantify this mutagenic...

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PMID: 40200886
DOI: 10.1089/hum.2024.221

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