Table 2.
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 |
ADSCs can be used after separation, cryopreservation, or cryopreservation and expansion processes. During these procedures, and regarding the medical devices used to separate SVF and ADSCs and to the stem cell facilities, variabilities in cell efficiency and clinical outcomes are observed. Continuous and standardized guidelines are proposed and reinforced through a flow chart during cell processing before delivery and in the point of care
GLP good laboratory practices, GCP good cell practices, GMP good manufacturing practices