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Please use this identifier to cite or link to this item: http://bura.brunel.ac.uk/handle/2438/29221
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dc.contributor.authorKlapwijk, JC-
dc.contributor.authorDel Rio Espinola, A-
dc.contributor.authorLibertini, S-
dc.contributor.authorCollin, P-
dc.contributor.authorFellows, MD-
dc.contributor.authorJobling, S-
dc.contributor.authorLynch, AM-
dc.contributor.authorMartus, H-
dc.contributor.authorVickers, C-
dc.contributor.authorZeller, A-
dc.contributor.authorBiasco, L-
dc.date.accessioned2024-06-18T13:01:46Z-
dc.date.available2024-06-18T13:01:46Z-
dc.date.issued2024-07-25-
dc.identifier.citationKlapwijk, 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.en_US
dc.identifier.issn1043-0342-
dc.identifier.urihttps://bura.brunel.ac.uk/handle/2438/29221-
dc.description.abstractRegulators 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.en_US
dc.description.sponsorshipThis work did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The UK NC3Rs supported attendance costs for EU and UK-based academic attendees and UKEMS provided bursaries for a number of the workshop attendees. NC3Rs hosted the workshop in London, March 2023.en_US
dc.format.mediumPrint-Electronic-
dc.languageEnglish-
dc.language.isoen_USen_US
dc.publisherMary Ann Lieberten_US
dc.rightsCopyright © 2024 The Author(s). This work is licensed under a Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/).-
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/-
dc.subjectgene therapy vectorsen_US
dc.subjectcarcinogenicityen_US
dc.subjectgenotoxicityen_US
dc.subjectnon-clinical safetyen_US
dc.titleImproving the assessment of risk factors relevant to potential carcinogenicity of gene therapies: a consensus paperen_US
dc.typeArticleen_US
dc.date.dateAccepted2024-06-06-
dc.relation.isPartOfHuman Gene Therapy-
pubs.publication-statusPublished online-
dc.identifier.eissn1557-7422-
dc.rights.licensehttps://creativecommons.org/licenses/by/4.0/legalcode.en-
dc.rights.holderThe Author(s)-
Appears in Collections:Institute of Environment, Health and Societies

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