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http://bura.brunel.ac.uk/handle/2438/29221| Title: | Improving the assessment of risk factors relevant to potential carcinogenicity of gene therapies: a consensus paper |
| Authors: | Klapwijk, JC Del Rio Espinola, A Libertini, S Collin, P Fellows, MD Jobling, S Lynch, AM Martus, H Vickers, C Zeller, A Biasco, L |
| Keywords: | gene therapy vectors;carcinogenicity;genotoxicity;non-clinical safety |
| Issue Date: | 25-Jul-2024 |
| Publisher: | Mary Ann Liebert |
| Citation: | Klapwijk, J.C. et al. (2024) 'Improving the assessment of risk factors relevant to potential carcinogenicity of gene therapies: a consensus paper', Human Gene Therapy, 0 (ahead of print), pp. 1 - [53]. doi: 10.1089/hum.2024.033. |
| Abstract: | Regulators and industry are actively seeking improvements and alternatives to current models and approaches to evaluate potential carcinogenicity of gene therapies (GTs). A meeting of invited experts was organised by NC3Rs/UKEMS (London, March 2023) to discuss this topic. This paper describes the consensus reached amongst delegates on the definition of vector genotoxicity, sources of uncertainty, suitable toxicological endpoints for genotoxic assessment of GTs, and future research needs. The collected recommendations should inform the further development of regulatory guidelines for the non-clinical toxicological assessment of GT products. |
| URI: | https://bura.brunel.ac.uk/handle/2438/29221 |
| ISSN: | 1043-0342 |
| Appears in Collections: | Institute of Environment, Health and Societies |
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| File | Description | Size | Format | |
|---|---|---|---|---|
| FullText.pdf | Copyright © 2024 The Author(s). This work is licensed under a Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/). | 914.2 kB | Adobe PDF | View/Open |
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