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©The Author(s) 2023.
World J Clin Cases. Jul 26, 2023; 11(21): 5083-5096
Published online Jul 26, 2023. doi: 10.12998/wjcc.v11.i21.5083
Published online Jul 26, 2023. doi: 10.12998/wjcc.v11.i21.5083
Table 1 Quality control standards of human umbilical cord-mesenchymal stem cells
| Test | Final frozen product | Final infusion product |
| Visual inspection | NA | Absence of visible, particle |
| Morphology | Fibroblastic | NA |
| Viability | ≥ 90% | ≥ 85% |
| Cell count | (4.5-6.0) × 107 | According to clinical needs |
| Pathogen tests | ||
| Sterility | Negative | Negative |
| Mycoplasma | Negative | Negative |
| Endotoxin | < 0.5 EU/mL | < 0.5 EU/mL |
| Cell surface markers | ||
| CD73 | ≥ 95% | - |
| CD90 | ≥ 95% | - |
| CD105 | ≥ 95% | - |
| CD29 | ≥ 95% | - |
| CD34 | ≤ 2% | - |
| CD45 | ≤ 2% | - |
| CD79a | ≤ 2% | - |
| CD14 | ≤ 2% | - |
| HLA-DR | ≤ 2% | - |
- Citation: Lian XF, Lu DH, Liu HL, Liu YJ, Yang Y, Lin Y, Xie F, Huang CH, Wu HM, Long AM, Hui CJ, Shi Y, Chen Y, Gao YF, Zhang F. Safety evaluation of human umbilical cord-mesenchymal stem cells in type 2 diabetes mellitus treatment: A phase 2 clinical trial. World J Clin Cases 2023; 11(21): 5083-5096
- URL: https://www.wjgnet.com/2307-8960/full/v11/i21/5083.htm
- DOI: https://dx.doi.org/10.12998/wjcc.v11.i21.5083