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Table 2 Tracking ADSCs testing from processing to delivery to the point of care

From: Overview of current adipose-derived stem cell (ADSCs) processing involved in therapeutic advancements: flow chart and regulation updates before and after COVID-19

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
  1. 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
  2. GLP good laboratory practices, GCP good cell practices, GMP good manufacturing practices