​

Mesenchymal stromal cells (MSCs) are a promising cellular therapy for a variety of medical conditions due to their regenerative properties, immunomodulatory effects, and ability to differentiate into multiple cell types. However, the successful clinical application of MSCs requires rigorous quality control (QC) validation to ensure consistency, safety, and efficacy. This abstract outlines the essential QC validation tests for MSCs, which are crucial for cell-based therapies. Key tests include phenotypic characterization, such as flow cytometry analysis to confirm the expression of surface markers (CD73, CD90, and CD105) and absence of hematopoietic markers (CD34, CD45). In vitro differentiation assays for adipogenesis, osteogenesis, and chondrogenesis are performed to assess multipotency. The absence of bacterial, fungal, and mycoplasma contamination is verified through microbiological testing. Additionally, sterility, endotoxin levels, and cell viability assays are conducted to ensure safety and functional integrity. Genetic stability is assessed using karyotyping or comparative genomic hybridization to detect chromosomal abnormalities. These comprehensive QC tests are critical in confirming that MSC products meet the stringent requirements for therapeutic use, maintaining reproducibility, and minimizing risks in clinical settings.​