DF-GMP-ZB12AN-I
EHTJUi004-A
General
Donor Information
General Donor Information |
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| Sex | female |
| Ethnicity | Han |
Phenotype and Disease related information (Donor) |
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| Diseases | No disease was diagnosed.
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| Disease associated phenotypes | no phenotypes |
Karyotyping (Donor) |
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| Has the donor karyotype been analysed? |
No
|
Other Genotyping (Donor) |
|
| Is there genome-wide genotyping or functional data available? |
Yes
Exome sequencing
A suspected pathogenic heterozygous mutation was found in DSP gene at c.4683_4684delCT (p.Leu1563fs) |
External Databases (Donor) |
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| BioSamples | SAMEA8394199 |
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. | 400-650-9496 |
| 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. | anonymised |
| 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 | |
| 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? | No |
| 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? | 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? | Human cell clinical research ethics committee of Shanghai East Hospital |
| Approval number | EC.D(BG).016.01.1 |
| 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? | Human cell clinical research ethics committee of Shanghai East Hospital |
| Approval number | EC.D(BG).016.01.1 |
| For generation of the cell line, who was the supplier of any recombined DNA vectors or commercial kits used? | |
hIPSC Derivation
General |
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| Source cell type |
Blood present in the umbilical vessels at the time of delivery. If cryopreserved at birth, cord blood can serve as a source of hematopoietic progenitor cells for transplantation to a patient later diagnosed and treated for a hematopoietic disorder.
Synonyms
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Reprogramming method |
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| Vector type | Non-integrating |
| Vector | Sendai virus |
| Genes | |
| Is reprogramming vector detectable? |
No |
| Methods used |
RT-PCR
|
Vector free reprogramming |
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Other |
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| Derived under xeno-free conditions |
Yes |
| Derived under GMP? |
Yes |
| Available as clinical grade? |
Yes |
Culture Conditions
| Surface coating | Laminin |
| Feeder cells |
No |
| Passage method |
Enzyme-free cell dissociation
Gentle Cell Dissociation Reagent
|
| CO2 Concentration | 5 % |
| Medium |
Other medium:
Base medium: StemFit
Main protein source: bFGF Serum concentration: % |
| 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
Score:
| Marker | Present | Absent |
| mCpG | ||
| OCT4 |
Self-renewal
Positive
Endoderm
Positive
Mesoderm
Positive
Ectoderm score
Positive
alkaline phosphatase staining
Differentiation Potency
In vitro directed differentiation
Microbiology / Virus Screening |
|
| HIV 1 | Negative |
| HIV 2 | Negative |
| Hepatitis B | Negative |
| Hepatitis C | Negative |
| Mycoplasma | Negative |
Genotyping
Karyotyping (Cell Line) |
|
| Has the cell line karyotype been analysed? |
Yes
46,XX
Passage number: 12
Karyotyping method:
G-Banding
|
Other Genotyping (Cell Line) |
|
| Is there genome-wide genotyping or functional data available? |
Yes
Exome sequencing
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