1. Brunel University Research Archive
  2. College of Health, Medicine and Life Sciences
  3. Dept of Life Sciences
  4. Dept of Life Sciences Research Papers
Please use this identifier to cite or link to this item: http://bura.brunel.ac.uk/handle/2438/29221
Full metadata record
DC FieldValueLanguage
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.contributor.authorBrugman, MH-
dc.contributor.authorBushmann, FD-
dc.contributor.authorCathomen, T-
dc.contributor.authorErtl, HCJ-
dc.contributor.authorGabriel, R-
dc.contributor.authorGao, G-
dc.contributor.authorJadlowsky, JK-
dc.contributor.authorKimber, I-
dc.contributor.authorLanz, TA-
dc.contributor.authorLevine, BL-
dc.contributor.authorMicklethwaite, KP-
dc.contributor.authorOnodera, M-
dc.contributor.authorPizzurro, DM-
dc.contributor.authorReed, S-
dc.contributor.authorRothe, M-
dc.contributor.authorSabatino, DE-
dc.contributor.authorSalk, JJ-
dc.contributor.authorSchambach, A-
dc.contributor.authorThemis, M-
dc.contributor.authorYuan, J-
dc.date.accessioned2024-06-18T13:01:46Z-
dc.date.available2024-06-18T13:01:46Z-
dc.date.issued2024-07-25-
dc.identifierORCiD: Jan C. Klapwijk https://orcid.org/0009-0007-6387-0192-
dc.identifierORCiD: Susan Jobling https://orcid.org/0000-0002-9322-9597-
dc.identifierORCiD: Catherine Vickers https://orcid.org/0009-0006-1642-5590-
dc.identifierORCiD: Toni Cathomen https://orcid.org/0000-0002-7757-4630-
dc.identifierORCiD: Hildegrund C.J. Ertl https://orcid.org/0000-0001-9795-5206-
dc.identifierORCiD: Axel Schambach https://orcid.org/0000-0003-2743-0070-
dc.identifierORCiD: Michael Themis https://orcid.org/0000-0002-6719-4271-
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, 35 (15-16), pp. 527 - 542. doi: 10.1089/hum.2024.033.en_US
dc.identifier.issn1043-0342-
dc.identifier.urihttps://bura.brunel.ac.uk/handle/2438/29221-
dc.descriptionSupplementary Material is available online at: https://www.liebertpub.com/doi/full/10.1089/hum.2024.033#supplementary-materials .-
dc.descriptionM.T. is a cofounder and Director of TestAVec Ltd., spun-out from Brunel University, and holds a patent concerning hInGetox “Method for Testing a Gene Therapy Vector” IP number PCT/GB2018/051937 with several collaborative projects in safety for gene therapy.-
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.rightsAttribution 4.0 International-
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.identifier.doihttps://doi.org/10.1089/hum.2024.033-
dc.relation.isPartOfHuman Gene Therapy-
pubs.issue15-16-
pubs.publication-statusPublished online-
pubs.volume35-
dc.identifier.eissn1557-7422-
dc.rights.licensehttps://creativecommons.org/licenses/by/4.0/legalcode.en-
dc.rights.holderThe Author(s)-
Appears in Collections:Environment
Dept of Life Sciences Research Papers

Files in This Item:
File Description SizeFormat 
FullText.pdfCopyright © The Author(s) 2024. Published by Mary Ann Liebert, Inc. This Open Access article is distributed under the terms of the Creative Commons License [CC-BY] (https://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.677.78 kBAdobe PDFView/Open
Show simple item record


This item is licensed under a Creative Commons License Creative Commons