Mesenchymal stem/stromal cell quality control: validation of mixed lymphocyte reaction assay using flow cytometry according to ICH Q2(R1).
Fiche publication
Date publication
octobre 2020
Journal
Stem cell research & therapy
Auteurs
Membres identifiés du Cancéropôle Est :
Dr REPPEL Loïc
Tous les auteurs :
Nicotra T, Desnos A, Halimi J, Antonot H, Reppel L, Belmas T, Freton A, Stranieri F, Mebarki M, Larghero J, Cras A, Faivre L
Lien Pubmed
Résumé
Mesenchymal stem/stromal cells (MSC) have immunomodulatory properties, studied in a wide range of diseases. Validated quality controls must confirm this activity in the context of clinical trials. This study presents a method's validation, assessing MSC's ability to inhibit lymphocyte proliferation, according to the ICH Q2 standard.
Mots clés
Biological assay, Clinical trial, Immune response modulation, Lymphocyte proliferation, MSC manufacturing, Mesenchymal stem/stromal cell, Mixed lymphocyte reaction, Potency assay, Quality control
Référence
Stem Cell Res Ther. 2020 10 1;11(1):426