UM134-1 PGD
UMICHe001-A
General
Donor Information
General Donor Information |
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| Sex | male |
Phenotype and Disease related information (Donor) |
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| Diseases | A disease was diagnosed.
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| Family history | spinocerebellar ataxia type 3 |
| Is the medical history available upon request? | yes |
| Is clinical information available? | yes |
Karyotyping (Donor) |
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| Has the donor karyotype been analysed? |
Yes
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Karyotyping method:
G-Banding
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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 | SAMEA110401635 |
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? | No |
| Please provide contact information of the holder of the original Donor Information Sheet. | mstemcell@umich.edu |
| Do you (Depositor/Provider) hold the original Donor Consent Form? | Yes |
| Alternatives to consent are available? | Yes |
| Alternatives to consent | |
| Alternative consent approval number | NIHhESC-14-0286 |
| 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? | Yes |
| 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? | No |
| 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? | Yes |
| How may genetic information associated with the cell line be accessed? | Open 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? | Yes |
| 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? | UM IRBMed |
| Approval number | HUM00028742 |
hESC Derivation
| Date of derivation | 2013-11-16 |
| Embryo stage | Blastula with ICM and Trophoblast |
| Supernumerary embryos from IVF treatment? |
Yes
Separation of research and IVF treatment?
Yes |
| PGD Embryo? |
Yes |
| Expansion status |
5
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| ICM morphology |
A
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| Trophectoderm morphology |
a
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| ZP removal technique | Mechanical |
| Cell isolation | Laser |
| Cell seeding | Isolated ICM |
| Derived under xeno-free conditions? |
No |
| Derivation under GMP? |
No |
| Available as clinical grade? |
No |
Culture Conditions
| Surface coating | Non coated |
| Feeder cells |
HFF |
| Passage method | Mechanically |
| O2 Concentration | 5 % |
| CO2 Concentration | 5 % |
| Medium |
mTeSR™ 1
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| Has Rock inhibitor (Y27632) been used at passage previously with this cell line? | No |
| 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? | No |
Characterisation
Analysis of Undifferentiated Cells
| Marker | Expressed | Immunostaining | RT-PCR | Flow Cytometry | Enzymatic Assay | Expression Profiles |
| NANOG |
Yes |
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| SOX2 |
Yes |
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| SSEA-3 |
Yes |
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| TRA 1-60 |
Yes |
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| POU5F1 (OCT-4) |
Yes |
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Differentiation Potency
Genotyping
Karyotyping (Cell Line) |
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| Has the cell line karyotype been analysed? |
Yes
46XY
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Other Genotyping (Cell Line) |
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