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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

Test

Method

Release criteria

Compliance

Sterility (aerobic, anaerobic, fungal)

BacT/ALERT, Gram stain

No growth at 7 days

225/225

Endotoxin

Gel Clot

< 0.5 EU/mL

225/225

Mycoplasma

PCR

Negative

225/225

Viability

Trypan blue dye exclusion

≥ 85%

225/225

BSA

ELISA

No detect

225/225