CBiPS1sv-4F-40
ESi007-A
General
Donor Information
General Donor Information |
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| Sex | female |
| Age of donor (at collection) | neonate |
Phenotype and Disease related information (Donor) |
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| Diseases | No disease was diagnosed.
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External Databases (Donor) |
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| BioSamples | SAMEA3303248 |
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. | Alessandra Giorgetti |
| 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? | No |
| Alternatives to consent are available? | No |
| Is there other documentation provided to the donor for consenting purposes? | 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 | Under the Law 14/2007, of 3rd July, on Biomedical Research and the Royal Decree 1527/2010 of November 15th |
| 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? | No |
| Does consent expressly prevent development of commercial products? | Yes |
| Does consent expressly prevent financial gain from any use of the donated embryo/tissue, including any product made from it? | Yes |
| Does consent expressly permit storage of 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? | No |
| a public organisation? | No |
| a non-profit company? | No |
| a for-profit corporation? | Yes |
| Does consent expressly permit collection of genetic information? | Yes |
| Has the donor been informed that their donated biosample or derived cells may be tested for the presence of microbiological agents / pathogens? | Yes |
| How may genetic information associated with the cell line be accessed? | No information |
| Will the donor expect to receive financial benefit, beyond reasonable expenses, in return for donating the biosample? | 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? | Yes |
| Does the consent permit the donor, upon withdrawal of consent, to stop delivery or use of information and data about the donor? | Yes |
| 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 Committee Center of Regenerative Medicine in Barcelona |
| 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? | Ethics Committee Center of Regenerative Medicine in Barcelona |
| Approval number | |
| 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 |
| 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 |
Any hematopoietic stem cell that is part of a umbilical cord blood.
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| Source cell origin |
Blood that remains in the placenta and in the attached umbilical cord after childbirth[WP].; Cord blood is collected because it contains stem cells, which can be used to treat hematopoietic and genetic disorders.[WP]
Synonyms
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| Source cell type (free text) | Cord blood CD133+ |
| Age of donor (at collection) | neonate |
Reprogramming method |
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| Vector type | Non-integrating |
| Vector | Sendai virus |
| Genes | |
| Is reprogramming vector detectable? |
No |
| Methods used |
RT-PCR
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Vector free reprogramming |
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Other |
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| Selection criteria for clones | morphological |
| Derived under xeno-free conditions |
No |
| Derived under GMP? |
No |
| Available as clinical grade? |
No |
Culture Conditions
| Surface coating | Gelatin | ||||||||||||||||||
| Feeder cells |
Mouse embryonic fibroblasts Cellfinder Ont Id: EFO_0004040 |
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| Passage method | Mechanically | ||||||||||||||||||
| CO2 Concentration | 5 % | ||||||||||||||||||
| Medium |
Other medium:
Base medium: Knockout DMEM
Main protein source: Knock-out serum replacement Serum concentration: 20 % Supplements
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Characterisation
Analysis of Undifferentiated Cells
| Marker | Expressed | Immunostaining | RT-PCR | Flow Cytometry | Enzymatic Assay | Expression Profiles |
| Alkaline Phosphatase |
Yes |
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| NANOG |
Yes |
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| POU5F1 (OCT-4) |
Yes |
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| SSEA-3 |
Yes |
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| TRA 1-60 |
Yes |
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| ZFP42 (REX-1) |
Yes |
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| SOX2 |
Yes |
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Differentiation Potency
In vivo teratoma
In vitro spontaneous differentiation
| Marker | Expressed |
| SMA |
Yes |
| MEOX |
Yes |
| AAP |
Yes |
In vivo teratoma
In vitro spontaneous differentiation
| Marker | Expressed |
| Tuj1 |
Yes |
| PAX6 |
Yes |
| NeuroD3 |
Yes |
| Sox1 |
Yes |
Microbiology / Virus Screening |
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| HIV 1 | Negative |
| HIV 2 | Negative |
| Hepatitis B | Negative |
| Hepatitis C | Negative |
| Mycoplasma | Negative |
Certificate of Analysis |
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| Is there a certificate of analysis available? |
Yes
Passage:
23
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Genotyping
Karyotyping (Cell Line) |
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| Has the cell line karyotype been analysed? |
Yes
46,XX
Karyotyping method:
G-Banding
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Other Genotyping (Cell Line) |
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| Is there genome-wide genotyping or functional data available? |
Yes
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