Validation of an ICH Q2 Compliant Flow Cytometry-Based Assay for the Assessment of the Inhibitory Potential of Mesenchymal Stromal Cells on T Cell Proliferation.
MSC manufacturing
flow cytometry
graft-versus-host disease
lymphocyte proliferation
mesenchymal stem/stromal cell
mixed lymphocyte reaction
potency assay
quality control
Journal
Cells
ISSN: 2073-4409
Titre abrégé: Cells
Pays: Switzerland
ID NLM: 101600052
Informations de publication
Date de publication:
09 03 2023
09 03 2023
Historique:
received:
07
02
2023
revised:
20
02
2023
accepted:
27
02
2023
medline:
30
3
2023
entrez:
29
3
2023
pubmed:
30
3
2023
Statut:
epublish
Résumé
Mesenchymal stromal cells (MSCs) have the potential to suppress pathological activation of immune cells and have therefore been considered for the treatment of Graft-versus-Host-Disease. The clinical application of MSCs requires a process validation to ensure consistent quality. A flow cytometry-based mixed lymphocyte reaction (MLR) was developed to analyse the inhibitory effect of MSCs on T cell proliferation. Monoclonal antibodies were used to stimulate T cell expansion and determine the effect of MSCs after four days of co-culture based on proliferation tracking with the violet proliferation dye VPD450. Following the guidelines of the International Council for Harmonisation (ICH) Q2 (R1), the performance of
Identifiants
pubmed: 36980191
pii: cells12060850
doi: 10.3390/cells12060850
pmc: PMC10047294
pii:
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Références
J Immunol Methods. 1994 Apr 15;170(2):211-24
pubmed: 8157999
Expert Rev Clin Immunol. 2017 Jan;13(1):43-56
pubmed: 27399600
Blood. 2002 May 15;99(10):3838-43
pubmed: 11986244
Cell Rep. 2018 Feb 27;22(9):2504-2517
pubmed: 29490284
Clin Exp Immunol. 1972 Mar;10(3):537-54
pubmed: 4556012
Science. 1999 Apr 2;284(5411):143-7
pubmed: 10102814
Eur J Immunol. 1994 Apr;24(4):812-6
pubmed: 7512031
Sci Transl Med. 2017 Nov 15;9(416):
pubmed: 29141887
Scand J Immunol. 2003 Jan;57(1):11-20
pubmed: 12542793
Cytometry B Clin Cytom. 2013 Sep-Oct;84(5):315-23
pubmed: 24022854
Cells. 2019 Dec 05;8(12):
pubmed: 31817480
J Immunol Methods. 1986 Jun 10;90(1):65-70
pubmed: 3711671
Immunogenetics. 1981;12(3-4):267-74
pubmed: 6451578
Trends Mol Med. 2019 Feb;25(2):149-163
pubmed: 30711482
J Immunol Methods. 1990 Apr 17;128(2):189-201
pubmed: 1691237
Curr Stem Cell Rep. 2022;8(2):72-92
pubmed: 35502223
Am J Clin Pathol. 2004 Feb;121(2):190-9
pubmed: 14983931
Bone Marrow Transplant. 2018 Jul;53(7):852-862
pubmed: 29379171
Cytometry B Clin Cytom. 2021 Jan;100(1):79-91
pubmed: 33373096
Immunol Lett. 1985;10(1):13-7
pubmed: 3159655
Nat Med. 2003 Jan;9(1):112-7
pubmed: 12514723
J Exp Med. 1985 Nov 1;162(5):1546-60
pubmed: 2932518
Proc Natl Acad Sci U S A. 1978 Oct;75(10):5132-6
pubmed: 154105
Hum Immunol. 1995 May;43(1):38-44
pubmed: 7558927
Front Immunol. 2018 May 16;9:1060
pubmed: 29868020
Blood. 2010 Nov 11;116(19):3770-9
pubmed: 20644118
Science. 1964 Sep 18;145(3638):1315-6
pubmed: 14173419
Immunology. 1994 Sep;83(1):38-44
pubmed: 7821964
Front Immunol. 2017 Dec 21;8:1870
pubmed: 29312346
Cytometry A. 2011 Feb;79(2):95-101
pubmed: 21265003
EBioMedicine. 2018 Feb;28:261-273
pubmed: 29366627
J Immunol Methods. 1991 Jul 5;140(2):243-8
pubmed: 1906076
Lancet. 2008 May 10;371(9624):1579-86
pubmed: 18468541
Cytotherapy. 2016 Feb;18(2):151-9
pubmed: 26724220
Immune Netw. 2018 Dec 19;18(6):e45
pubmed: 30619631
Exp Mol Med. 2009 May 31;41(5):315-24
pubmed: 19307751
Nat Immunol. 2003 Sep;4(9):835-42
pubmed: 12942084
Cytotherapy. 2006;8(4):315-7
pubmed: 16923606
Nat Rev Immunol. 2016 Feb;16(2):102-11
pubmed: 26781939
Eur J Immunol. 2005 Oct;35(10):2851-63
pubmed: 16180253
Front Immunol. 2022 Mar 02;13:830773
pubmed: 35309367
Stem Cell Res Ther. 2015 Dec 01;6:236
pubmed: 26620155
Eur J Immunol. 1992 Nov;22(11):2995-3000
pubmed: 1385158
J Immunol Methods. 2011 Jan 5;363(2):120-34
pubmed: 20946898
J Exp Med. 1983 Feb 1;157(2):613-27
pubmed: 6185614
Stem Cells. 2017 Mar;35(3):766-776
pubmed: 27671847
Bone Marrow Transplant. 1995 Oct;16(4):557-64
pubmed: 8528172
Pharm Res. 2006 Feb;23(2):312-28
pubmed: 16397743
Cytotherapy. 2016 Jan;18(1):13-24
pubmed: 26631828
Nat Commun. 2022 Feb 14;13(1):856
pubmed: 35165293
Immunol Lett. 2001 Sep 3;78(2):75-82
pubmed: 11672590
Clin Exp Immunol. 1972 May;11(1):89-98
pubmed: 5038773
Nat Protoc. 2007;2(9):2049-56
pubmed: 17853860
Exp Hematol. 2003 Oct;31(10):890-6
pubmed: 14550804
Front Immunol. 2022 Jun 20;13:893545
pubmed: 35795679
Haematologica. 2016 Aug;101(8):985-94
pubmed: 27175026
Stem Cell Res Ther. 2020 Oct 1;11(1):426
pubmed: 33004063
PLoS One. 2010 Apr 26;5(4):e10088
pubmed: 20436665
Leukemia. 2020 Jul;34(7):1907-1923
pubmed: 32047237
Biol Blood Marrow Transplant. 2014 Feb;20(2):229-35
pubmed: 24216185
Bioanalysis. 2017 Aug;9(16):1253-1264
pubmed: 28766359
Clin Exp Immunol. 1970 Feb;6(2):255-62
pubmed: 5435719
Nat Rev Immunol. 2008 Sep;8(9):726-36
pubmed: 19172693
J Immunol. 1982 Jan;128(1):337-42
pubmed: 6459373
Appl Math Lett. 2013 May 1;26(5):571-577
pubmed: 23526173
Cytotherapy. 2018 Apr;20(4):532-542
pubmed: 29500069