Characterization analysis of clinical quality mesenchymal stem cell final products obtained from different stages of the production batch for clinical practice

Title: Detailed analysis of mesenchymal stem cell final product profiles ready to use for clinical application Objective: In this thesis study, it was aimed to analyze in detail the phenotypic, genotypic, functional, molecular, and immunosuppressive characteristics of the final products obtained from different stages of the umbilical cord Wharton's Jelly-derived Mesenchymal Stem Cell (WJ-MSC) series produced under Good Manufacturing Practice (GMP) conditions, and to compare the results with each other. Methods: WJ-MSCs were isolated and expanded to passage 3, then cryopreserved. The cryopreserved cells were thawed and divided into 4 groups. On the final products, morphological analyses, cell count and viability, immunophenotyping, tumorigenicity, gene expression analysis, potency analysis, apoptosis assay, cell cycle analysis, CFSE viability and proliferation analysis, growth factor analysis, and in vitro wound healing assays were performed. Findings: The cells were successfully brought to the final product stage. While differences were observed in terms of genotypic, functional, and molecular aspects, no significant difference was found in terms of morphological, immunophenotypic, and immunosuppressive aspects. Conclusion: It was determined that the cryopreservation and thawing of WJ-MSCs may have effects in clinical applications, and allowing a recovery period by culturing the cells before reaching the final product stage may yield more efficient results. Keywords: Mesenchymal stem cell, good manufacturing practices, GMP, advanced therapy medicinal product, ATMP, cellular therapy, clinical use, final product