Table 5.
Summary of methods for information only used for the characterization of hPSCs for clinical usage.
| Characteristics | Method | Test interval |
|---|---|---|
| Differentiation | Teratoma formation | WCB |
| Genetic stability | SNP analysis | WCB |
| Whole-genome sequencing | WCB | |
| Cancer predisposition testing | WCB | |
| Histocompatibility | HLA typing | Dependent on application* |
| Pluripotency | Immunocytochemistry | EP, MCB, WCB |
| Alkaline phosphatase | EP, MCB, WCB | |
| Pluripotency/Differentiation | Transcriptome analysis | WCB |
* When establishing hiPSC and hESC banks for HLA-matched tissue, transplantation donor testing or EP is advantageous.