DFGMP-ZB11AL-D	
    			    			
                EHTJUi005-A            
            
        General
Donor Information
| General Donor Information | |
| Sex | female | 
| Ethnicity | Han | 
| Phenotype and Disease related information (Donor) | |
| Diseases | No disease was diagnosed. | 
| Disease associated phenotypes | no phenotypes | 
| Karyotyping (Donor) | |
| Has the donor karyotype been analysed? | No | 
| Other Genotyping (Donor) | |
| Is there genome-wide genotyping or functional data available? | Yes 
										Exome sequencing										
																				
										 Health | 
| External Databases (Donor) | |
| BioSamples | SAMEA8883269 | 
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 | 
| 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 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 | |
| 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 
 | 
| Reprogramming method | |
| Vector type | Non-integrating | 
| Vector | Sendai virus | 
| Genes | |
| Is reprogramming vector detectable? | No | 
| Methods used | 
	RT-PCR	 | 
| Vector free reprogramming | |
| Other | |
| 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: 15											 
											Karyotyping method:
											G-Banding											
																						 | 
| Other Genotyping (Cell Line) | |
| Is there genome-wide genotyping or functional data available? | Yes 
											Exome sequencing											
																						
    										 Healthy | 

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