CIRM Human Pluripotent Stem Cell Lines

Non-integrating episomal reprogramming. Reprogramming and quality control performed by Cellular Dynamics International. Donors screened and negative for HIV, HBV, and HCV*.

Handling of lines:

*Lines are grown feeder free on E8/vitronectin and are frozen in colony form.

Donor Consenting:

Each donors consent included statements on the following:
  • Testing the cells’ DNA (this is referred to as the cell’s genetic code or sequence) and making the information known to other researchers

  • Changing some of the genetic code or sequence within these cells

  • Using cells to test or select drugs to treat disease

  • Transplanting cells or resulting products to humans or animals

  • Distributing cells widely (nationally and internationally) for research, training or commercial medical product development

  • Future research and uses unforeseen at this time

Quality Control:

Chromosomal Integrity

SNP microarray 
(Illumina Infinium HumanCore BeadChip).

No deletions or amplifications larger than 5MB (resolution of traditional G-banding assay) on SNP arrays with LogRDev score less than 0.5.

Donor DNA is tested on all abnormal clones to whether the genetic abnormality is due to 
in vitro culture or is pre-­existing in the donor. If the abnormality is pre-­existing in donor, the   iPSC line is released to Repository.

Pluripotency Analysis of gene expression by qPCR 
of 48 mRNAs.
A non-­probabilistic binary linear classifier identifies the gene expression of the sample as 
iPSC based on an appropriate training set. This method has been benchedmarked against traditional teratoma assays for pluripotency. 
Identity 
Confirmation
Genotyping using PCR assay for 48 SNPs. ≤1 mismatch between donor and iPSC line.
Loss of 
Reprogramming
Transgenes
Endpoint multiplex PCR for 2 plasmid 
sequences (EBNA and OriP).
Detection of ≤1 plasmid copy per 100 cells or a decrease in the number of plasmid copies detected at passage 5.
Mycoplasma qPCR for 8 species. Negative for all 8 species.
Sterility Microbiological testing by third-‐party 
Service Provider
Negative for all tests.