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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