Table 2. Standardization and Quality Control of hESCs for Clinical Use.

Requirement	Methods of Testing
Cell line identity	Short Tandem Repeat (STR) testing Human Leukocyte Antigen (HLA) testing
Sterility and pathogens	Bacteria/fungi/mycoplasma culture qPCR analysis for murine viral short interspersed elements (SINE)
Genetic/chromosomal stability	Single Nucleotide Polymorphism (SNP) analysis G-band karyotype analysis spreads Fluorescent in situ hybridization
Epigenetic stability	MicroRNA profiling Methylation analysis X-inactivation
Pluripotency	Teratoma formation SSEA-3/4, TRA-1-60, TRA-1-81 detection
Quality and differentiation ability	Gene expression profiling qPCR analysis Embryoid body formation
Functional assays	Potency Efficacy Lot-to-lot variability