Table 1: Basic assays for MSC-based products.

Specifications	Assays	Criteria
		Positive	Negative
Donor screening	Testing for virus and other communicable disease	N/A	HTLV-1, HTLV-2 and CMV, HIV-1, HIV-2, HBV, HCV, Treponema pallidum, human transmissible spongiform encephalopathy (including CJD), and other communicable disease associated with xenotransplantation
Viability test	Viability Assay	> 70%	N/A
Purity test	Residual contaminants tests	N/A	Residual peptides, proteins, and reagents
	Pyrogenicity/endotoxin tests	Endotoxin:< 5 EU/kg body weight/dose (for intrathecally administered drugs is < 0.2 EU/kg body weight/dose)
Safety test	Bacterial and fungal test	N/A	Bacteria and fungi
	Mycoplasma test	N/A	Mycoplasma
	Adventitious viral agent test	N/A	Virus
	Tumorigenicity assays (karyotype analysis, teratoma formation assay, soft agar assay, CGH, FISH, and PCR)	N/A	Chromosomal abnormalities, teratoma formation, colony formation
Identity test	Immunophenotypic profiles	High expression (95%) of CD105, CD73, and CD90	Lack of expression (< 2%) of CD45, CD34, CD11b, CD14, CD38, CD19, CD31, and HLA-DR
Potency test	Multilineage differentiation ability assays	Osteogenic lineages	N/A
		Adipogenic lineages	N/A
		Chondrogenic lineages	N/A
	Secretion Profiles	FGF-2, HGF, EGF, LIF and others	N/A
	CFU-F assay	Colony formation	N/A
	Immunosuppressive assay	Surface molecules and co-stimulatory molecules	N/A

Abbreviations: CFU-F: Colony-forming unit – fibroblast; CGH: Comparative Genomic Hybridization; CJD: Creutzfeldt-Jakob Disease; CMV: Cytomegalovirus; EGF: Epidermal growth factor; FGF-2, Basic fibroblast growth factor-2; FISH: Fluorescence in situ hybridization; HBV, HCV: Hepatitis B and C viruses; HGF, Hepatocyte growth factor; HIV-1, HIV-2: Human immunodeficiency virus types 1 and 2; HLA-DR, Human leukocyte antigen - antigen D related; HTLV-1, HTLV-2: Human T-lymphotropic virus types 1 and 2; LIF, Leukemia inhibitory factor; N/A: Not Applicable; PCR: Polymerase chain reaction