Table 1.
Characterization and validation.
| Classification | Test | Result | Data |
|---|---|---|---|
|
| |||
| Morphology | Photography | Normal iPSC-like morphology | Fig. 1 Panel A |
| Phenotype | Quantitative analysis: RT-qPCR | Positive expression of undifferentiated iPSC state markers Nanog, Sox2, and Oct3/4 in the two DM1 lines and absent in differentiated CMs | Fig. 1 Panel B |
| Qualitative analysis: Immunofluorescence staining | Positive expression of Nanog, Sox2, and Oct3/4 in both lines | Fig. 1 Panel C | |
| Genotype | Whole genome array (KaryoStat™ Assay) Resolution 1–2 Mb] | Normal karyotype: 46, XX for both lines | Fig. 1 Panel E |
| Identity | Microsatellite PCR (mPCR) or | N/A | N/A |
| STR analysis | Exact match | Submitted to an archive with a journal | |
| Mutation analysis (IF APPLICABLE) | Southern blot or WGS | N/A | N/A |
| Southern blot or WGS | N/A | N/A | |
| Microbiology and virology | Mycoplasma | Mycoplasma testing by luminescence: Negative | Fig. 1 Panel F |
| Differentiation potential | Directed differentiation | Positive IF staining of three germ layer markers | Fig. 1 Panel D |
| List of recommended germ layer markers | Expression of these markers has to be demonstrated at mRNA(RT-qPCR) or protein (IF) levels, at least 2 markers need to be shown per germ layer | Ectoderm: Pax6, Otx2 Endoderm: Sox17, Foxa2 Mesoderm: Brachyury, Tbx6 |
Fig. 1 Panel D |
| Donor screening (OPTIONAL) | HIV 1 + 2, Hepatitis B, Hepatitis C | N/A | N/A |
| Genotype additional info (OPTIONAL) | Blood group genotyping | N/A | N/A |
| HLA tissue typing | N/A | N/A | |