CIMHi44f028#4
CIMHi001-A
General
Donor Information
General Donor Information |
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| Sex | female |
| Age of donor (at collection) | 40-44 |
| Ethnicity | caucasian |
Phenotype and Disease related information (Donor) |
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| Diseases | No disease was diagnosed.
|
Karyotyping (Donor) |
|
| Has the donor karyotype been analysed? |
No
|
Other Genotyping (Donor) |
|
| Is there genome-wide genotyping or functional data available? |
No
|
External Databases (Donor) |
|
| BioSamples | SAMEA5230378 |
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 |
| 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? | Unknown |
| 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 |
| 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? | 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 expressly permit storage of donated embryo/tissue for an unlimited time? | Yes |
| Does consent expressly permit storage of cells derived from the 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 |
| Does consent expressly permit storage of genetic information? | Yes |
| 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? | 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 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? | Ethics comittee II, Prof. Dr. Striebel, Medical Faculty Mannheim, University of Heidelberg |
| Approval number | 2009-350N-MA |
| 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? | Ethics comittee II, Prof. Dr. Striebel, Medical Faculty Mannheim, University of Heidelberg |
| Approval number | 2009-350N-MA |
| Do you have obligations to third parties in regard to the use of the cell line? | No |
| 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? | No |
| For generation of the cell line, who was the supplier of any recombined DNA vectors or commercial kits used? | Thermo Fisher Scientific |
| 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 |
|
| Source cell type | |
| Source cell origin |
Dermal fibroblasts are the major cell type in dermis and are commonly accepted as terminally differentiated cells.
|
| Age of donor (at collection) | 40-44 |
| Collected in | 2013 |
| Passage number reprogrammed | 3 |
Reprogramming method |
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| Vector type | Non-integrating |
| Vector | Sendai virus |
| Is reprogramming vector detectable? |
Yes |
| Methods used |
RT-PCR
|
| Notes on reprogramming vector detection | absence of Sendai virus checked by RT-PCR after passage 8 |
| Files and images showing reprogramming vector expressed or silenced | |
Vector free reprogramming |
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Other |
|
| Selection criteria for clones | morphology |
| 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
|
| O2 Concentration | 21 % |
| CO2 Concentration | 5 % |
| Medium |
Essential 8™
|
| 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? | Yes |
| 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 |
| POU5F1 (OCT-4) |
Yes |
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| SOX2 |
Yes |
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| SSEA-4 |
Yes |
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| TRA 1-60 |
Yes |
| Pluripotency Score | Novelty Score | |
| 14.082 | 1.317 |
Report
pluritest_image01.png
Novelty score; Sample I corresponds to 028-line
pluritest_image02.png
pluripotency score; sample I corresponds to 028-line
Morphology pictures
Differentiation Potency
In vitro spontaneous differentiation
In vitro directed differentiation
| Marker | Expressed |
| Homo sapiens microtubule associated protein tau (MAPT) |
Yes |
| MAP2 microtubule associated protein 2 |
Yes |
Morphology
028#4_d15_Map488+Tau555_20x_02.tif
Immunofluorescent analysis of axonal marker protein Tau and somatodendritic marker protein Map2a on d15 of terminal differentiation.
Microbiology / Virus Screening |
|
| Mycoplasma | Negative |
Genotyping
Karyotyping (Cell Line) |
|
| Has the cell line karyotype been analysed? |
Yes
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Other Genotyping (Cell Line) |
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