Ensuring the safety and efficacy of Mesenchymal Stem Cell products mandates stringent Quality Assurance protocols and comprehensive final product release criteria. Beyond the basic ISCT criteria for cell identity and a high threshold for cell viability (typically $>70\%$ or even $>90\%$), release testing is divided into critical safety, purity, and potency assays. Safety testing includes mandatory screens for microbiological contamination (sterility, mycoplasma, endotoxins) and genetic stability (karyotyping) to rule out tumorigenicity resulting from long-term culture.

The most challenging component is establishing a standardized potency assay, which must reflect the cell's intended mechanism of action, be it immunomodulation or differentiation. Regulators are increasingly calling for functional assays—such as the ability to suppress T-cell proliferation in vitro or the expression of key trophic factors—as surrogate measures of clinical efficacy. Furthermore, for intravascular administration, tests for Procoagulant Tissue Factor (TF/CD142) expression are crucial new safety criteria to mitigate the risk of thrombosis.

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