Table 2 Quality control tests for oral mucosal epithelial cell sheets
Criteria | Results | |
|---|---|---|
Sterility tests | ||
Aerobic bacteria | (–) | (–) |
Anaerobic bacteria | (–) | (–) |
Fungi | (–) | (–) |
Endotoxin test | < 1.0 EU/mL | 0.260 EU/mL |
Mycoplasma tests | ||
Cultivation | (–) | (–) |
DNA of M. pneumoniae | (–) | (–) |
Quality of the sheet | ||
Total cells | > 1.0 × 105 cells/sheet | 2.14 × 105 cells/sheet |
Cellular density | > 2.38 × 104 cell/cm2 | 5.09 × 104 cell/cm2 |
Viability | > 70% | 98.1% |
Percentage of epithelial cells | > 70% | 99.1% |