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Table 4 Summary of quality controls performed on HUCMSCs and compliance with the release criteria

From: The quality evaluation system establishment of mesenchymal stromal cells for cell-based therapy products

TestMethodRelease criteriaCompliance
Sterility (aerobic, anaerobic, fungal)BacT/ALERT, Gram stainNo growth at 7 days225/225
EndotoxinGel Clot< 0.5 EU/mL225/225
ViabilityTrypan blue dye exclusion≥ 85%225/225
BSAELISANo detect225/225