PRPF31 RH
UNEWi005-A
General
Donor Information
General Donor Information |
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| Sex | male |
| Age of donor (at collection) | 50-54 |
Phenotype and Disease related information (Donor) |
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| Diseases | A disease was diagnosed.
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| Disease associated phenotypes |
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Karyotyping (Donor) |
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| Has the donor karyotype been analysed? |
Yes
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External Databases (Donor) |
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| BioSamples | SAMEA3275922 |
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? | No |
| Has the donor been informed that participation will not directly influence their personal treatment? | No |
| 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 |
| Has the donor been informed about how her/his data will be protected? | 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? | Yes |
| 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 |
| Does consent expressly permit collection of genetic information? | Yes |
| Has the donor been informed that their donated biosample or derived cells may be tested for the presence of microbiological agents / pathogens? | Yes |
| 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? | Yes |
| 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 |
| Does consent permit access to medical records of the donor? | No |
| Does consent permit access to any other source of information about the clinical treatment or health of 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? | NRES Committee North East Newcastle and Tyneside 1 |
| Approval number | 11/NE/0294 |
| Has a favourable opinion been obtained from a research ethics committee, or other ethics review panel, in relation to the PROPOSED PROJECT, involving use of donated embryo/tissue or derived cells? | Yes |
| Name of accrediting authority involved? | NRES Committee North East Newcastle and Tyneside 1 |
| Approval number | 11/NE/0294 |
| Do you have obligations to third parties in regard to the use of the cell line? | Yes |
| Please describe: | Only be used for “eye disease research” due to restrictions mentioned in the original donor consent form. |
| Are you aware of any further constraints on the use of the donated embryo/tissue or derived cells? | No |
| 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 |
fibroblast of dermis |
| Source cell origin |
zone of skinAny portion of the organ that covers that body and consists of a layer of epidermis and a layer of dermis.
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| Age of donor (at collection) | 50-54 |
Reprogramming method |
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| Vector type | Non-integrating |
| Vector | Sendai virus |
| Genes | |
Vector free reprogramming |
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Other |
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| Derived under xeno-free conditions |
No |
| Derived under GMP? |
No |
| Available as clinical grade? |
Unknown |
Culture Conditions
| Surface coating | Matrigel/Geltrex |
| Passage method |
Enzyme-free cell dissociation
EDTA
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| O2 Concentration | 20 % |
| CO2 Concentration | 5 % |
| Medium | mTeSR™ 1 |
Characterisation
Analysis of Undifferentiated Cells
| Marker | Expressed | Immunostaining | RT-PCR | FACS | Enzymatic Assay | Expression Profiles |
| NANOG |
Yes |
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| SSEA-4 |
Yes |
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| TRA 1-60 |
Yes |
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| SSEA-1 |
No |
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| POU5F1 (OCT-4) |
Yes |
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Differentiation Potency
Microbiology / Virus Screening |
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| HIV 1 | Negative |
| HIV 2 | Negative |
| Hepatitis B | Negative |
| Hepatitis C | Negative |
| Mycoplasma | Negative |
Certificate of Analysis |
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| Is there a certificate of analysis available? |
Yes
Passage:
26
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Genotyping
Karyotyping (Cell Line) |
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| Has the cell line karyotype been analysed? |
Yes
CytoSNP
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Other Genotyping (Cell Line) |
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