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DC Field | Value | Language |
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dc.contributor.author | Fraser, H | - |
dc.contributor.author | Safinia, N | - |
dc.contributor.author | Grageda, N | - |
dc.contributor.author | Thirkell, S | - |
dc.contributor.author | Lowe, K | - |
dc.contributor.author | Fry, LJ | - |
dc.contributor.author | Scottá, C | - |
dc.contributor.author | Hope, A | - |
dc.contributor.author | Fisher, C | - |
dc.contributor.author | Hilton, R | - |
dc.contributor.author | Game, D | - |
dc.contributor.author | Harden, P | - |
dc.contributor.author | Bushell, A | - |
dc.contributor.author | Wood, K | - |
dc.contributor.author | Lechler, RI | - |
dc.contributor.author | Lombardi, G | - |
dc.date.accessioned | 2024-06-17T14:29:05Z | - |
dc.date.available | 2024-06-17T14:29:05Z | - |
dc.date.issued | 2018-01-31 | - |
dc.identifier | ORCiD: Cristiano Scottá https://orcid.org/0000-0003-3942-5201 | - |
dc.identifier.citation | Fraser, H. et al. (2018) 'A Rapamycin-Based GMP-Compatible Process for the Isolation and Expansion of Regulatory T Cells for Clinical Trials', Molecular Therapy Methods and Clinical Development, 8, pp. 198 - 209. doi: 10.1016/j.omtm.2018.01.006. | en_US |
dc.identifier.uri | https://bura.brunel.ac.uk/handle/2438/29206 | - |
dc.description | Supplemental Information is available online at: https://www.sciencedirect.com/science/article/pii/S232905011830007X#app2 . | en_US |
dc.description.abstract | The concept of regulatory T cell (Treg)-based immunotherapy has enormous potential for facilitating tolerance in autoimmunity and transplantation. Clinical translation of Treg cell therapy requires production processes that satisfy the rigors of Good Manufacturing Practice (GMP) standards. In this regard, we report our findings on the implementation of a robust GMP compliant process for the ex vivo expansion of clinical grade Tregs, demonstrating the feasibility of this developed process for the manufacture of a final product for clinical application. This Treg isolation procedure ensured the selection of a pure Treg population that underwent a 300-fold expansion after 36 days of culture, while maintaining a purity of more than 75% CD4+CD25+FOXP3+ cells and a suppressive function of above 80%. Furthermore, we report the successful cryopreservation of the final product, demonstrating the maintenance of phenotype and function. The process outlined in this manuscript has been implemented in the ONE study, a multicenter phase I/IIa clinical trial in which cellular therapy is investigated in renal transplantation. | en_US |
dc.description.sponsorship | This work was supported by the King’s Health Partners Research and Development Challenge Fund, Guy’s and St Thomas’ Charity (grant no. R1405170), the British Heart Foundation, ONE Study, European Cooperation in Science and Technology (COST; part of the EU Framework Programme Horizon 2020) for the AFACTT project (Action to Focus and Accelerate Cell-based Tolerance inducing Therapies; BM1305), the Medical Research Council (MRC) (within the MRC Centre for Transplantation, King’s College London, UK; MRC grant no. MR/J006742/1), and the National Institute for Health Research (NIHR) Biomedical Research Centre at Guy’s and St Thomas’ NHS Foundation Trust and King’s College London. | en_US |
dc.format.extent | 198 - 209 | - |
dc.format.medium | Electronic | - |
dc.language.iso | en_US | en_US |
dc.publisher | Cell Press on behalf of The American Society of Gene and Cell Therapy | en_US |
dc.rights | Copyright © 2018 The Authors. Published by Cell Press on behalf of The American Society of Gene and Cell Therapy. This is an open access article under a Creative Commons license (https://creativecommons.org/licenses/by/4.0/). | - |
dc.rights.uri | https://creativecommons.org/licenses/by/4.0/ | - |
dc.subject | Tregs | en_US |
dc.subject | GMP process | en_US |
dc.subject | clinical trials | en_US |
dc.subject | cell therapy | en_US |
dc.subject | ONE study | en_US |
dc.subject | solid organ transplantation | en_US |
dc.title | A Rapamycin-Based GMP-Compatible Process for the Isolation and Expansion of Regulatory T Cells for Clinical Trials | en_US |
dc.type | Article | en_US |
dc.date.dateAccepted | 2018-03-16 | - |
dc.identifier.doi | https://doi.org/10.1016/j.omtm.2018.01.006 | - |
dc.relation.isPartOf | Molecular Therapy Methods and Clinical Development | - |
pubs.publication-status | Published | - |
pubs.volume | 8 | - |
dc.identifier.eissn | 2329-0501 | - |
dc.rights.license | https://creativecommons.org/licenses/by/4.0/legalcode.en | - |
dc.rights.holder | The Authors | - |
Appears in Collections: | Dept of Life Sciences Research Papers |
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FullText.pdf | Copyright © 2018 The Authors. Published by Cell Press on behalf of The American Society of Gene and Cell Therapy. This is an open access article under a Creative Commons license (https://creativecommons.org/licenses/by/4.0/). | 912.32 kB | Adobe PDF | View/Open |
This item is licensed under a Creative Commons License