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 |