Academic Journal
Increasing robustness of in vitro assay for immnosuppressive effect of mesenchymal stromal/stem cells: The role of inflammatory cytokine production by peripheral blood mononuclear cells
العنوان: | Increasing robustness of in vitro assay for immnosuppressive effect of mesenchymal stromal/stem cells: The role of inflammatory cytokine production by peripheral blood mononuclear cells |
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المؤلفون: | Rumi Sawada, Shinji Kusakawa, Mika Kusuhara, Kazusa Tanaka, Takumi Miura, Satoshi Yasuda, Yoji Sato |
المصدر: | Regenerative Therapy, Vol 28, Iss , Pp 321-332 (2025) |
بيانات النشر: | Elsevier, 2025. |
سنة النشر: | 2025 |
المجموعة: | LCC:Medicine (General) LCC:Cytology |
مصطلحات موضوعية: | MLR assay, MSC, PBMC proliferation, Inflammatory cytokines, CQA, QbD, Medicine (General), R5-920, Cytology, QH573-671 |
الوصف: | Introduction: The Quality by Design (QbD) approach for developing cell therapy products using mesenchymal stromal/stem cells (MSCs) is a promising method for designing manufacturing processes to improve the quality of MSC products. It is crucial to ensure the reproducibility and robustness of the test system for evaluating critical quality attributes (CQAs) in the QbD approach for manufacturing of pharmaceutical products. In this study, we explored the key factors involved in establishing a robust evaluation system for the immunosuppressive effect of MSCs, which can be an example of a CQA in developing and manufacturing therapeutic MSCs for treating graft-versus-host disease, etc, and we have identified method attributes to increase the robustness of a simple in vitro assay to assess the immunosuppressive effects of MSCs. Methods: We evaluated the performance of an assay system to examine the proliferation of peripheral blood mononuclear cells (PBMCs) activated with the mitogen phytohemagglutinin (PHA) when co-cultured with MSCs, the so-called one-way mixed lymphocyte reaction (MLR) assay. The MLR assay was performed on the same MSCs using 10 PBMC lots from different donors. In addition, 13 cytokine production levels in PHA-stimulated PBMCs were assessed. Results: The PHA-stimulated proliferation response of PBMCs, the action of MSCs in the MLR test, and the cytokine release of the respective PBMCs significantly differed among the PBMC lots (p |
نوع الوثيقة: | article |
وصف الملف: | electronic resource |
اللغة: | English |
تدمد: | 2352-3204 |
Relation: | http://www.sciencedirect.com/science/article/pii/S2352320424002360; https://doaj.org/toc/2352-3204 |
DOI: | 10.1016/j.reth.2024.12.016 |
URL الوصول: | https://doaj.org/article/34656a7df5ab42bc9e1626f2220f6dee |
رقم الانضمام: | edsdoj.34656a7df5ab42bc9e1626f2220f6dee |
قاعدة البيانات: | Directory of Open Access Journals |
تدمد: | 23523204 |
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DOI: | 10.1016/j.reth.2024.12.016 |