| Autor: |
Rebelatto CLK; Core for Cell Technology, School of Medicine, Pontifícia Universidade Católica do Paraná, Curitiba 80215-901, Brazil.; National Institute of Science and Technology for Regenerative Medicine-INCT-REGENERA, Rio de Janeiro 21941-599, Brazil., Boldrini-Leite LM; Core for Cell Technology, School of Medicine, Pontifícia Universidade Católica do Paraná, Curitiba 80215-901, Brazil.; National Institute of Science and Technology for Regenerative Medicine-INCT-REGENERA, Rio de Janeiro 21941-599, Brazil., Daga DR; Core for Cell Technology, School of Medicine, Pontifícia Universidade Católica do Paraná, Curitiba 80215-901, Brazil.; National Institute of Science and Technology for Regenerative Medicine-INCT-REGENERA, Rio de Janeiro 21941-599, Brazil., Marsaro DB; Core for Cell Technology, School of Medicine, Pontifícia Universidade Católica do Paraná, Curitiba 80215-901, Brazil.; National Institute of Science and Technology for Regenerative Medicine-INCT-REGENERA, Rio de Janeiro 21941-599, Brazil., Vaz IM; Core for Cell Technology, School of Medicine, Pontifícia Universidade Católica do Paraná, Curitiba 80215-901, Brazil.; National Institute of Science and Technology for Regenerative Medicine-INCT-REGENERA, Rio de Janeiro 21941-599, Brazil., Jamur VR; Core for Cell Technology, School of Medicine, Pontifícia Universidade Católica do Paraná, Curitiba 80215-901, Brazil.; National Institute of Science and Technology for Regenerative Medicine-INCT-REGENERA, Rio de Janeiro 21941-599, Brazil., de Aguiar AM; Laboratory of Basic Biology of Stem Cells, Carlos Chagas Institute-Fiocruz-Paraná, Curitiba 81350-010, Brazil., Vieira TB; Core for Cell Technology, School of Medicine, Pontifícia Universidade Católica do Paraná, Curitiba 80215-901, Brazil., Furman BP; Core for Cell Technology, School of Medicine, Pontifícia Universidade Católica do Paraná, Curitiba 80215-901, Brazil., Aguiar CO; Core for Cell Technology, School of Medicine, Pontifícia Universidade Católica do Paraná, Curitiba 80215-901, Brazil., Brofman PRS; Core for Cell Technology, School of Medicine, Pontifícia Universidade Católica do Paraná, Curitiba 80215-901, Brazil.; National Institute of Science and Technology for Regenerative Medicine-INCT-REGENERA, Rio de Janeiro 21941-599, Brazil. |
| Abstrakt: |
Mesenchymal stromal cells (MSCs) have been considered a therapeutic strategy in regenerative medicine because of their regenerative and immunomodulatory properties. The translation of MSC-based products has some challenges, such as regulatory and scientific issues. Quality control should be standardized and optimized to guarantee the reproducibility, safety, and efficacy of MSC-based products to be administered to patients. The aim of this study was to develop MSC-based products for use in clinical practice. Quality control assays include cell characterization, cell viability, immunogenicity, and cell differentiation; safety tests such as procoagulant tissue factor (TF), microbiological, mycoplasma, endotoxin, genomic stability, and tumorigenicity tests; and potency tests. The results confirm that the cells express MSC markers; an average cell viability of 96.9%; a low expression of HLA-DR and costimulatory molecules; differentiation potential; a high expression of TF/CD142; an absence of pathogenic microorganisms; negative endotoxins; an absence of chromosomal abnormalities; an absence of genotoxicity and tumorigenicity; and T-lymphocyte proliferation inhibition potential. This study shows the relevance of standardizing the manufacturing process and quality controls to reduce variability due to the heterogeneity between donors. The results might also be useful for the implementation and optimization of new analytical techniques and automated methods to improve safety, which are the major concerns related to MSC-based therapy. |
