HS975
KIe032-A
General
Donor Information
General Donor Information |
|
| Sex | female |
Phenotype and Disease related information (Donor) |
|
| Diseases | No disease was diagnosed.
|
| Disease associated phenotypes | no phenotypes |
Karyotyping (Donor) |
|
| Has the donor karyotype been analysed? |
Unknown
|
Other Genotyping (Donor) |
|
| Is there genome-wide genotyping or functional data available? |
No
|
External Databases (Donor) |
|
| BioSamples | SAMEA6878149 |
Ethics
| Was the embryo established purely for research purposes? | No |
| Have both parents consented to the use of the embryo for ESC derivation? | Yes |
| 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? | No |
| If you do not hold the Donor Consent Form, do you know who does? | Yes |
| Please provide the contact information | ganesh.acharya@ki.se |
| 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? | No |
| 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? | Yes |
| Details on restriction to research project | Establishment of human embryonic stem cells of clinical quality |
| Does consent permit unforeseen future research, without further consent? | No |
| 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? | 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? | Yes |
| 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 prevent dissemination of genetic information? | 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? | Yes |
| 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? | Regional Ethics Committee, Stockholm, Sweden |
| Approval number | |
| 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? | Regional Ethics Committee, Stockholm, Sweden |
| Approval number | 2011:745:31-3 - clinical |
| 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? | Yes |
| 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 |
hESC Derivation
| Date of derivation | 2012-03-19 |
| Embryo stage | Blastula with ICM and Trophoblast |
| Supernumerary embryos from IVF treatment? |
Yes
Separation of research and IVF treatment?
Yes |
| PGD Embryo? |
No |
| Expansion status |
6
|
| ICM morphology |
A
|
| Trophectoderm morphology |
b
|
| ZP removal technique | Spontaneous Hatching |
| Cell isolation | Mechanical |
| Cell seeding | Isolated ICM |
| Derived under xeno-free conditions? |
Yes |
| Derivation under GMP? |
No |
| Available as clinical grade? |
No |
Culture Conditions
| Surface coating | Laminin |
| Feeder cells |
No |
| Passage method |
Enzymatically
TrypLE
|
| O2 Concentration | 5 % |
| CO2 Concentration | 5 % |
| Medium |
mTeSR™ 2
|
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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| SSEA-4 |
Yes |
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| TRA 1-60 |
Yes |
Differentiation Potency
Genotyping
Karyotyping (Cell Line) |
|
| Has the cell line karyotype been analysed? |
Yes
46XX/47XX+8
Karyotyping method:
G-Banding
|
Other Genotyping (Cell Line) |
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