01175
CMDi004-A
General
Donor Information
General Donor Information |
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| Sex | male |
| Age of donor (at collection) | 5-9 |
Phenotype and Disease related information (Donor) |
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| Diseases | A disease was diagnosed.
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External Databases (Donor) |
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| BioSamples | SAMEA112655524 |
Ethics
| Has informed consent been obtained from the donor of the embryo/tissue from which the pluripotent stem cells have been derived? | Yes |
| Was the consent voluntarily given? | Yes |
| Has the donor been informed that participation will not directly influence their personal treatment? | Yes |
| Can you provide us with a copy of the Donor Information Sheet provided to the donor? | Yes |
| Do you (Depositor/Provider) hold the original Donor Consent Form? | Yes |
| Please indicate whether the data associated with the donated material has been pseudonymised or anonymised. | pseudonymised |
| Does consent explicitly allow the derivation of pluripotent stem cells? | Yes |
| * Does consent pertain to a specific research project? | No |
| Does consent permit unforeseen future research, without further consent? | Yes |
| Does consent expressly prevent development of commercial products? | No |
| Does consent expressly prevent financial gain from any use of the donated embryo/tissue, including any product made from it? | No |
| Does consent prevent the DONATED BIOSAMPLE from being made available to researchers anywhere in the world? | No |
| Does consent prevent CELLS DERIVED FROM THE DONATED BIOSAMPLE from being made available to researchers anywhere in the world? | No |
| How may genetic information associated with the cell line be accessed? | Controlled Access |
| Will the donor expect to receive financial benefit, beyond reasonable expenses, in return for donating the biosample? | No |
| Does the consent permit the donor, upon withdrawal of consent, to stop the use of the derived cell line(s) that have already been created from donated samples? | No |
| Does the consent permit the donor, upon withdrawal of consent, to stop delivery or use of information and data about the donor? | No |
| Has a favourable opinion been obtained from a research ethics committee, or other ethics review panel, in relation to the Research Protocol including the consent provisions? | Yes |
| Name of accrediting authority involved? | |
| Approval number | |
| Do you have obligations to third parties in regard to the use of the cell line? | Yes |
| Please describe: | LIMITED LICENSE; USE RESTRICTIONS. Recipient acknowledges that the Cells and the methods used to create them embody intellectual property deemed to be of significant value to FCDI and its licensors, and that such intellectual property is protected by the law of patents, copyrights, trade secrets, and other laws. Recipient acknowledges and agrees that neither these terms nor the receipt of the Cells by Recipient shall be construed as a transfer of any title or the grant of any rights in, to or under the intellectual property embodied in the Cells owned or licensed by FCDI. The Cells are covered by certain pending patents and/or patents, which may be found under MyCell Products at https://fujifilmcdi.com/about-us/patents/. The Cells are also covered by a number of patents and pending patents licensed to FCDI from iPS Academia Japan Inc., including Japanese Patent Nos. 4183742, 4411362, 4411363. Neither FCDI nor its licensor, iPS Academia Japan, Inc. makes any warranty or representation as to the validity, scope, or enforceability of the patents owned by or licensed to FCDI. Recipient has a limited license to use the Cells and derivatives solely for Recipient’s internal academic research purposes, subject to these Use Restrictions. No other right, express or implied, is conveyed by the provision of the Cells. In particular, no right to make, have made, offer to sell, or sell the Cells or derivatives is implied by the provision of the Cells. The license granted herein does not imply or convey the right to use the Cells or derivatives in combination with any other product(s) whose manufacture, sale, or use is covered by any patent owned by any third party. Recipient must use the Cells and derivatives solely for Recipient’s internal academic research purposes. Not by way of limitation of the immediately preceding provision but by way of example, Recipient may not use the Cells or derivatives for commercial purposes of any kind, including without limitation, to manufacture of any products or to provide services to a third party, or for sponsored research of any kind where intellectual property rights or options to intellectual property rights may be granted to the commercial sponsor of such research. Recipient may propagate no more than 120,000,000 live Cells of any one line at any one time (approximately the number of cells in 10 conventional culture plates) at the Institution. Recipient shall not sell or transfer the Cells or derivatives. The Cells must be used in accordance with any applicable FCDI User’s Guide. Recipient may differentiate the Cells using publicly available or its own differentiation methods. Recipient shall not use FCDI’s patented and/or proprietary methods for differentiation of the Cells, and (not by way of limitation of what is provided above but by way of example) no license to use such methods is conveyed herein. Recipient shall not reverse engineer the Cells in any way. Recipient shall not use the Cells or derivatives in humans, in clinical trials or for diagnostic purposes involving human subjects, for any therapeutic use or investigational use, or for any purpose in contravention of any applicable law, regulation, ordinance, institutional review board approved protocol, or privacy office approval. |
| Are you aware of any further constraints on the use of the donated embryo/tissue or derived cells? | No |
| Is there an MTA available for the cell line? | Yes |
| For generation of the cell line, who was the supplier of any recombined DNA vectors or commercial kits used? |
hIPSC Derivation
General |
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| Source cell type |
A liquid tissue; its major function is to transport oxygen throughout the body. It also supplies the tissues with nutrients, removes waste products, and contains various components of the immune system defending the body against infection. Several hormones also travel in the blood.
Synonyms
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| Age of donor (at collection) | 5-9 |
Reprogramming method |
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| Vector type | Non-integrating |
| Vector | Episomal |
| Is reprogramming vector detectable? |
No |
Vector free reprogramming |
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Other |
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| Derived under xeno-free conditions |
Unknown |
| Derived under GMP? |
Unknown |
| Available as clinical grade? |
Unknown |
Culture Conditions
| Medium |
Essential 8™
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Characterisation
Analysis of Undifferentiated Cells
| Marker | Expressed | Immunostaining | RT-PCR | Flow Cytometry | Enzymatic Assay | Expression Profiles |
| POU5F1 (OCT-4) |
Yes |
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| NANOG |
Yes |
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| Lin28 |
Yes |
Undifferentiated cells were analyzed by proprietary assays as described in the attached publication. Pluripotency of established iPSC cultures were tested by qPCR on bulk samples using 48 genes including standard pluripotency genes (listed above). Samples were assigned a passing score after analysis with a non-supervised classifier based on an appropriate sample set. (Novak, T. 2015. Drug Discovery World pp. 47-53.)
Differentiation Potency
Microbiology / Virus Screening |
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| HIV 1 | Negative |
| HIV 2 | Negative |
| Hepatitis B | Negative |
| Hepatitis C | Negative |
| Mycoplasma | Negative |
Genotyping
Karyotyping (Cell Line) |
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| Has the cell line karyotype been analysed? |
Yes
Normal
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Other Genotyping (Cell Line) |
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