Journal
MOLECULAR THERAPY-METHODS & CLINICAL DEVELOPMENT
Volume 8, Issue -, Pages 198-209Publisher
CELL PRESS
DOI: 10.1016/j.omtm.2018.01.006
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Funding
- King's Health Partners Research and Development Challenge Fund
- Guy's and St Thomas' Charity [R1405170]
- British Heart Foundation
- ONE Study
- European Cooperation in Science and Technology (COST) part of the EU Framework Programme Horizon [BM1305]
- Medical Research Council (MRC) within the MRC Centre for Transplantation, King's College London, UK [MR/J006742/1]
- National Institute for Health Research (NIHR) Biomedical Research Centre at Guy's and St Thomas' NHS Foundation Trust and King's College London
- MRC [MR/K025538/1] Funding Source: UKRI
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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.
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