Test Catalog

Osteogenic Differentiation of Mesenchymal Cells

Code: CEL020

Type: Control de qualitat de medicaments de teràpia avançada

Clinical information

Diagnostic utility:

This test evaluates the ability of mesenchymal cells to differentiate in vitro into an osteogenic lineage in the presence of induction medium. It is detected through specific stains such as alkaline phosphatase enzymatic activity and/or Alizarin Red staining that reveals the presence of calcium salts. This potency test is used for both quality control of Advanced Therapy Medicinal Products (ATMPs) for clinical use and for the evaluation of cells from research projects.

Method: 

Cell culture.

Reference values

The results are qualitative. The expected values are:

  • sample cultured in induction medium: positive staining (bluish colour in alkaline phosphatase and red mineral deposits in Alizarin Red) and
  • control sample cultured in basal medium: negative staining (absence of colour).

Diagnostic algorithm:

Not applicable.

Response time:

30 days.

Specimen information

Sample: Sterile sample of mesenchymal cells in fresh (culture) or thawed state.
Tube: Additive-free tube
Minimum volume: 300 µL containing 1X10^6 viable cells.

Stability:

  • Fresh sample: 1 day
  • Thawed samples: 2 hours

Transport instructions: Room temperature.

Reason for rejection: Sample with clots.

Administrative information

BST Code: CEL020
Test Description: Osteogenic differentiation of mesenchymal cells.
Synonyms: Not applicable
Section: Cellular Laboratory
BST Rate: Check the updated rates here.

Profiles:

Not applicable.

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.

Salvi Prat et al; Clinical translation of a Mesenchymal Stromal Cell-based therapy developed in a large animal model and two case studies of the treatment of atrophic pseudoarthrosis Journal of Tissue Engineering and Regenerative Medicine, 2016.

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.