Frequently Asked Questions
What is the CIRM iPSC Repository?
The CIRM iPSC Repository is a bank of human induced pluripotent stem cells (iPSCs) containing one line from each of approximately 2,500 individuals, 80% of which come from donors having a variety of multigenic disorders and the balance being controls. The donors were selected by leading California researchers to create informative iPSC lines. Donor samples were converted into iPSC lines by FUJIFILM Cellular Dynamics, Inc. (FCDI), using its proprietary episomal reprogramming method that does not introduce exogenous DNA into the iPSC lines. The CIRM iPSC Repository is maintained and administered by FCDI, which is also responsible for storing and distributing de-identified donor clinical information associated with the CIRM iPSC Repository samples.
How can I order a sample from the CIRM iPSC Repository?
Every requester must execute the provided, non-negotiable, Material Transfer Agreement with FCDI, which can be downloaded from the ordering webpage. Commercial entities and academics or non-profits engaged in commercial activities must take a patent license from FCDI using the Standard License Agreement for the CIRM iPSC Repository. Commercial activity by an academic or non-profit entity is defined as fee-for-service or sponsored research or other arrangements in which another party has rights to the output of the work performed, even if the work is done by a non-profit.
What are the fees for access to the iPSC lines?
There are two separate fees associated with the CIRM iPSC Repository. There is a fee of $1,500 per vial of iPSCs for a commercial entity and $750 per vial for an academic or non-profit entity. If an entity needs a patent license, a separate fee will be paid to FCDI under the Standard License Agreement.
If I need a patent license, what do I need to do?
A potential requester who wishes to be licensed can print the Standard License Agreement for the CIRM iPSC Repository, execute it by a duly authorized person, and deliver the signed license agreement to FCDI with payment of the initial license fee. The requester is then licensed.
Are the license fees for a single iPSC line or for all the lines in the repository?
The Standard License Agreement for the CIRM iPSC Repository covers all the iPSC lines in the bank. The license fees are not per line but for the entire bank.
Is there any reach-through claim on the license?
FCDI or CIRM will not claim ownership of a discovery that arises from the use of the iPSC line(s). For example, if the iPSC line(s) or derivatives of them are used in experiments that establish a new small molecule or protein drug candidate, that discovery is owned by the licensee. FCDI has no claim on the discovery. On the other hand, if an activity requires continued use of iPSC line(s), such as making differentiated cells for use in fee-for-hire screening services, that activity requires both a license and the payment of royalties to FCDI under the Standard License Agreement.
If my organization already has a license from iPS Academia Japan (iPS AJ), does my organization pay less fees or get a credit on their fees paid?
iPS AJ has informed FCDI that, as of August 2015, no entity has a license from iPS AJ that is as broad in the research tools space as the license rights available here. Any organization that wishes to explore what credits may be available because of an existing license from iPS AJ may contact FCDI, but again additional license fees may apply. On the other hand, no organization should be required to pay royalties twice. If your organization is only doing activities licensed by iPS AJ, an adjustment for royalty fees will be given.
What information is included in the donor consent?
Each donor's consent included statements on the following:
- Testing the cells’ DNA 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, both nationally and internationally, for research, training, or commercial medical product development
- Future research and uses unforeseen at this time
What testing is performed on the samples?
Donors were screened for infectious diseases including Human Immunodeficiency Virus (HIV), Hepatitis B (HBV), and Hepatitis C (HCV). Donors under the age of 18 could opt out of HIV testing; all HCV-positive donors submitted skin punches, not peripheral blood, and were not screened for any infectious agents due to small volume of blood present in punches. Additionally, each line undergoes quality control testing that includes:
- Chromosomal integrity
- Identity confirmation
- Loss of reprogramming transgenes
How were the samples reprogrammed?
All lines in the CIRM iPSC Repository are created by the same standardized procedure in a single production facility operated by FCDI to minimize lab to lab variability. The samples are reprogrammed by FCDI’s proprietary methods employing non-integrating episomal vectors.
How were the iPSC lines cultured and cryopreserved?
All lines are grown using Essential 8 Medium and vitronectin (VTN-N) and cryopreserved in colony form.
FCDI recommends culturing the iPSC lines using Essential 8 Medium and vitronectin (both available from Thermo Fisher Scientific). Alternatively, the cells can also be cultured using TeSR Medium (available from STEMCELL Technologies) and Matrigel Matrix (available from Corning). It is advised to use the passaging and cryopreservation protocol and reagents recommended by the vendor of the culture medium used.
Is there genomic sequencing or genotype confirmation of mutations in the diseased lines available?
Due to the number of samples in the repository, no genomic or genotyping data have been generated.