P02-1
BCRTi002-A
General
Donor Information
General Donor Information |
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| Sex | female |
| Age of donor (at collection) | 20-24 |
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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| Non-disease associated phenotypes |
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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? | No |
| Can you provide us with a copy of the Donor Information Sheet provided to the donor? | No |
| Please provide contact information of the holder of the original Donor Information Sheet. | |
| Do you (Depositor/Provider) hold the original Donor Consent Form? | No |
| If you do not hold the Donor Consent Form, do you know who does? | No |
| Please provide the contact information | |
| Alternatives to consent | |
| Alternative consent approval number | |
| 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 expressly prevent the derivation of pluripotent stem cells? | No |
| Does consent pertain to a specific research project? | No |
| Details on restriction to research project | |
| Does consent permit unforeseen future research, without further consent? | Yes |
| Does the consent permit uses of donated embryo/tissue or derived cell line intended for clinical treatment or human applications? | No |
| Does consent expressly permit storage of donated embryo/tissue for an unlimited time? | 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 permit research by | |
| an academic institution? | Yes |
| a public organisation? | Yes |
| a non-profit company? | Yes |
| a for-profit corporation? | Yes |
| 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? | 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? | Yes |
| Does the consent permit the donor, upon withdrawal of consent, to stop delivery or use of information and data about the donor? | Yes |
| Does consent permit access to medical records of the donor? | No |
| Please describe how access is provided: | |
| Does consent permit access to any other source of information about the clinical treatment or health of the donor? | No |
| Contact data, institution, or website: | |
| 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? | Ethikkommission der Charite - Universitätsmedizin Berlin |
| Approval number | EA2/047/14 |
| 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? | Ethikkommission der Charite - Universitätsmedizin Berlin |
| Approval number | EA2/047/14 |
| Please describe: | |
| Are you aware of any further constraints on the use of the donated embryo/tissue or derived cells? | No |
| Further constraints on use | |
| For generation of the cell line, who was the supplier of any recombined DNA vectors or commercial kits used? | ThermoFischer SCIENTFIC |
| Are you aware of any constraints on the use or distribution of the cell line from the owner or any parties identified in the query above? | No |
| Constraints for use or distribution | |
hIPSC Derivation
General |
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| Source cell origin |
Excretion that is the output of a kidney.
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| Age of donor (at collection) | 20-24 |
| Collected in | 2015 |
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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| Selection criteria for clones | Mophology |
| Derived under xeno-free conditions |
No |
| Derived under GMP? |
No |
| Available as clinical grade? |
No |
Culture Conditions
| Surface coating | Matrigel/Geltrex |
| Feeder cells |
No |
| Passage method |
Enzyme-free cell dissociation
EDTA
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| O2 Concentration | 5 % |
| CO2 Concentration | 5 % |
| 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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| SSEA-4 |
Yes |
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| TRA 1-60 |
Yes |
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| TRA 1-81 |
Yes |
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Morphology pictures
30 d post reprogramming
Differentiation Potency
In vitro spontaneous differentiation
| Marker | Expressed |
| SOX17 |
Yes |
| FOXA2 |
Yes |
In vitro spontaneous differentiation
Microbiology / Virus Screening |
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| HIV 1 | 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
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Other Genotyping (Cell Line) |
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| Is there genome-wide genotyping or functional data available? |
Yes
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