LUMC0145iKLHL01
LUMCi045-A
General
Donor Information
General Donor Information |
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| Sex | male |
| Ethnicity | Hispanic, Chilean |
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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| Family history | patient 14 in Schwieger-Briel et al., 2018 (10.1016/j.jid.2018.07.022) |
Karyotyping (Donor) |
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| Has the donor karyotype been analysed? |
No
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Other Genotyping (Donor) |
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| Is there genome-wide genotyping or functional data available? |
No
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External Databases (Donor) |
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| BioSamples | SAMEA8868390 |
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? | No |
| Please provide contact information of the holder of the original Donor Information Sheet. | Ignacia Fuentes, Debra, Chile |
| 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? | Yes |
| Please provide the contact information | Ignacia Fuentes, Debra, Chile |
| Alternatives to consent are available? | No |
| Is there other documentation provided to the donor for consenting purposes? | No |
| Confirm that consent was obtained by a qualified professional | Yes |
| Has the donor agreed to be re-contacted? | 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. | anonymised |
| Does consent explicitly allow the derivation of pluripotent stem cells? | No |
| Does consent expressly prevent the derivation of pluripotent stem cells? | No |
| Does consent pertain to a specific research project? | No |
| 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 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 expressly permit storage of donated embryo/tissue for an unlimited time? | No |
| Does consent expressly permit storage of cells derived from the donated embryo/tissue for an unlimited time? | 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 |
Does consent permit research by | |
| an academic institution? | Yes |
| a public organisation? | No |
| a non-profit company? | Yes |
| a for-profit corporation? | No |
| Does consent expressly permit collection of genetic information? | No |
| Does consent expressly permit storage of genetic information? | No |
| Does consent prevent dissemination of genetic information? | No |
| Has the donor been informed that their donated biosample or derived cells may be tested for the presence of microbiological agents / pathogens? | No |
| Has the donor consented to receive information discovered during use of donated embryo/tissue that has significant health implications for the donor? | 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 anticipate that the donor will be notified of results or outcomes of any research involving the donated samples or derived cells? | 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 |
| 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? | Comité Ético Científico, Facultad de Medicina, Clinica Alemana-Universidad del Desarrollo |
| Approval number | Project number 2013-145 |
| 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? | Leiden University ethics committee |
| Approval number | P 13.080 |
| Do you have obligations to third parties in regard to the use of the cell line? | Yes |
| Please describe: | To be used on project related to epidermolysis bullosa |
| Are you aware of any further constraints on the use of the donated embryo/tissue or derived cells? | Yes |
| Further constraints on use | The third party has to be informed and approve new research to be carried on with this cell line |
| Is there an MTA available for the cell line? | No |
| For generation of the cell line, who was the supplier of any recombined DNA vectors or commercial kits used? | N. Nakanishi (National Institute of Advanced Industrial Science and Technology, Japan) Sendai Virus |
| 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 |
hIPSC Derivation
General |
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| Source cell type |
Any skin fibroblast that is part of some dermis.
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| Source cell type (free text) | WK13189 |
| Passage number reprogrammed | 3 |
Reprogramming method |
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| Vector type | Non-integrating |
| Vector | Sendai virus |
| Is reprogramming vector detectable? |
No |
| Methods used |
RT-PCR
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| Files and images showing reprogramming vector expressed or silenced | |
Vector free reprogramming |
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| Type of used vector free reprogramming factor(s) |
None
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Other |
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| Selection criteria for clones | Morphology |
| Derived under xeno-free conditions |
No |
| Derived under GMP? |
No |
| Available as clinical grade? |
No |
Culture Conditions
| Surface coating | Vitronectin |
| Feeder cells |
No |
| Passage method |
Enzyme-free cell dissociation
Gentle Cell Dissociation Reagent
|
| O2 Concentration | 20 % |
| CO2 Concentration | 5 % |
| Medium |
TeSR™ E8™
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| Has Rock inhibitor (Y27632) been used at passage previously with this cell line? | Yes |
| Has Rock inhibitor (Y27632) been used at cryo previously with this cell line? | No |
| Has Rock inhibitor (Y27632) been used at thaw previously with this cell line? | Yes |
Characterisation
Analysis of Undifferentiated Cells
| Marker | Expressed | Immunostaining | RT-PCR | Flow Cytometry | Enzymatic Assay | Expression Profiles |
| SSEA-4 |
Yes |
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| NANOG |
Yes |
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| POU5F1 (OCT-4) |
Yes |
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Score:
| Marker | Present | Absent |
| mCpG | ||
| OCT4 |
Differentiation Potency
In vitro spontaneous differentiation
| Marker | Expressed |
| alpha fetoprotein (AFP) |
Yes |
In vitro spontaneous differentiation
| Marker | Expressed |
| beta-III tubulin |
Yes |
Microbiology / Virus Screening |
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| Mycoplasma | Negative |
Genotyping
Karyotyping (Cell Line) |
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| Has the cell line karyotype been analysed? |
Yes
46,XY[20]
Passage number: 22
Karyotyping method:
G-Banding
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Other Genotyping (Cell Line) |
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