. Author manuscript; available in PMC: 2022 Jul 18.

Published in final edited form as: Stem Cell Rev Rep. 2020 Oct;16(5):979–991. doi: 10.1007/s12015-020-10015-8

Table 1.

Quality Control of MSCTC-0010, Suspension for Infusion

Analytical test	Method	Acceptance Criteria
Appearance	Off-white, opaque, homogeneous suspension following mixing	Visual, no clumps
Phenotype	Flow Cytometry	≥ 80% CD73, CD90, CD105 ≤ 2% CD45, CD34, CD11b, CD19, HLA DR
Cell Viability	Flow Cytometry	≥ 80%
Potency by Immunosuppression	Inhibition of PHA-induced proliferation of hPBMC by WJMSC	≥ 20%
Endotoxin	Bacterial endotoxin USP <85>	< 12.5 EU/ml
Mycoplasma	Biochemical luminescence assay	Absence of mycoplasma
Sterility	Microbiological control of cellular product USP <71>	Absence of micro organisms
Chromosomal Stability	Karyotype	Absence of chromosomal alterations

EU = endotoxin units, hPBMC= human peripheral blood mononuclear cells.