Processing conditions before administration | Location | Performed actions before delivery | Proposed actions before delivery | Actions on the point of care |
---|---|---|---|---|
Separated ADSCs (autologous use) | Patient bedside Cell therapy units under GLP and GCP | Viability, cell dose Functional assay (CFU-F) CD73, CD90, CD105, CD34, CD45, CD14, HLA-DR Microbial, endotoxine, mycoplasma testing | CD271, CD274, CD276, CD163, CD63 expression Cytometry and q-RT-PCR | Viability Sterility apoptotic activity |
Cryopreserved and thawed (autologous and allogenic use) | Stem cell facility under GMP | Viability, cell dose Functional assay (CFU-F) CD73, CD90, CD105, CD34, CD45, CD14, HLA-DR Microbial, endotoxine, mycoplasma testing | CD271, CD274, CD276, CD163, CD63 expression Apoptotic activity IL-6, TNF-α and IFN expression level (q-RT-PCR) | Viability Sterility Apoptotic activity |
Cryopreserved, thawed and expanded (autologous and allogenic use) | Stem cell facility under GMP | Viability, cell dose Functional assay (CFU-F) CD73, CD90, CD105, CD34, CD45, CD14, HLA-DR Microbial, endotoxine, mycoplasma testing | CD271, 274, CD276, CD163, CD63 expression Apoptotic activity Karyotype Migration’s genes IL-6, TNF-α, and IFN expression level (q-RT-PCR) | Viability Sterility Apoptotic activity |