Phenotype Mesenchymal Cells
Code: CEL014
Type: Control de qualitat de medicaments de teràpia avançada
Clinical information
Diagnostic Utility:
This test evaluates the phenotype of mesenchymal cells from fresh cultures or thawed products. It is applied both for quality control of advanced therapy medicinal products (ATMPs) and for the characterization of cells from research projects. Mesenchymal cells can originate from bone marrow (BM), Wharton's jelly from umbilical cord (UC), amniotic fluid (AF), etc. The membrane receptors analysed are CD105, CD45, CD31, CD73, CD90, and HLA-DR.
Method:
Flow Cytometry.
Reference Values
The results are quantitative. Expected values vary depending on the origin of mesenchymal cells and are as follows:
| Phenotypic Marker | BM-MSCs | UC-MSCs |
|---|---|---|
| CD105+/CD45- | ≥90% | ≥95% |
| ≥40 | ≥90% | ≥95% |
| CD73+/CD31- | ≥90% | ≥950% |
| HLA-DR- | Informative Value | Informative Value |
Diagnostic Algorithm:
Not applicable.
Turnaround Time:
1 day.
Specimen information
Sample: Cultures of fresh mesenchymal cells or thawed products.
Tube: Tube without additive
Minimum volume: 300 µL
Stability:
- Sample in fresh: 1 day
- Thawed samples: 1 hour
Transport instructions: Ambient temperature.
Reason for rejection: Sample with aggregates.
Administrative information
BST Code: CEL014
Test Description: Mesenchymal cell phenotype.
Synonyms: Phen MSCs
Section: Cellular Laboratory
BST Rate: Check updated rates here.
Profiles:
Test CEL014 Mesenchymal Cell Phenotype can be requested on its own. It is also performed within the following profiles:
| Profile Name | Profile Code |
|---|---|
| PERICORD03 | PER3 |
References
Codinach M et al.; Design and validation of a consistent and reproducible manufacture process for the production of clinical-grade bone marrow-derived multipotent mesenchymal stromal cells; Cytotherapy, 2016, 18-9, pp.1197-1208.
Quality
BST holds ISO 9001, ISO 14001, and OSHAS 18001 quality certifications, as well as the European Excellence 500+ seal. BST is accredited by CAT, JACIE-FACT, FACT-NETCORD, and EFI, and complies with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) guidelines.