FDCHDP01	
    			    			
                FDCHDPi001-A            
            
        General
Donor Information
General Donor Information | 
					|
| Sex | male | 
| Age of donor (at collection) | 10-14 | 
| Ethnicity | Chinese Han | 
Phenotype and Disease related information (Donor) | 
					|
| Diseases | A disease was diagnosed.
																	 | 
					
| Disease associated phenotypes | 
								
  | 
						
| Family history | The donor's father also suffers from Tourette syndrome. | 
| Is the medical history available upon request? | The medical history will be available upon request by the user of the cell line. | 
| Is clinical information available? | The clinical information will be available upon request by the user of the cell line. | 
Karyotyping (Donor) | 
						|
| Has the donor karyotype been analysed? | 
								 Yes 								
																	
															 | 
						
Other Genotyping (Donor) | 
						|
| Is there genome-wide genotyping or functional data available? | 
								 No 								
															 | 
						
External Databases (Donor) | 
						|
| BioSamples | SAMEA7059987 | 
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? | Yes | 
| 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? | 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. | pseudonymised | 
| Does consent explicitly allow the derivation of pluripotent stem cells? | 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 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 for-profit corporation? | 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 | 
| 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? | Yes | 
| Please describe how access is provided: | |
| 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? | Ethics Committee of childre's hospital of Fudan University | 
| Approval number | (2019) 308 | 
| 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 of childre's hospital of Fudan University | 
| Approval number | (2019) 308 | 
| 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 | 
										
				
	
			 A leukocyte with a single non-segmented nucleus in the mature form found in the circulatory pool of blood. 
	
									 | 
							
| Source cell origin | 
										
				
	
	
			 Synonyms 
		
  | 
							
| Source cell line lot number | 
									 STD003P 
																 | 
							
| Age of donor (at collection) | 10-14 | 
| Collected in | 2019 | 
| Passage number reprogrammed | 16 | 
Reprogramming method | 
						|
| Vector type | Non-integrating | 
| Vector | Episomal | 
| Is reprogramming vector detectable? | 
										 No 									 | 
								
| Methods used | 
										 
	PCR	 
									 | 
								
| Files and images showing reprogramming vector expressed or silenced | |
| Vector map | |
Vector free reprogramming | 
						|
| Type of used vector free reprogramming factor(s) | 
								 
	None	 
							 | 
						
Other | 
						|
| Selection criteria for clones | expressing SOX2, NANOG, TRA-1-60 and OCT4 | 
| Derived under xeno-free conditions | 
								 Unknown 							 | 
						
| Derived under GMP? | 
								 Yes 							 | 
						
| Available as clinical grade? | 
								 No 							 | 
						
Culture Conditions
| Surface coating | Matrigel/Geltrex | |||||||||
| Feeder cells | 
																								 Mouse Embryonic Fibroblast  | 
						|||||||||
| Passage method | 
								Enzymatically
								
																			 
											Collagenase										 
																	
								
							 | 
						|||||||||
| O2 Concentration | 21 % | |||||||||
| CO2 Concentration | 5 % | |||||||||
| Medium | 
								Other medium:		 
			Base medium: Dulbecco's Modified Eagle's Medium F-12 Ham			 
				
				Main protein source: Knock-out serum replacement Serum concentration: 20 % Supplements 
				
  | 
						|||||||||
| 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  | 
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| 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 | 
| SOX2 | 
											 Yes 						                 | 
																                
						                
						                	 | 
						                ||||
| NANOG | 
											 Yes 						                 | 
																                
						                
						                	 | 
						                ||||
| TRA 1-60 | 
											 Yes 						                 | 
																                
						                
						                	 | 
						                ||||
| POU5F1 (OCT-4) | 
											 Yes 						                 | 
																                
						                
								Self-renewal
							
							Positive
							
								Endoderm
							
							Positive
							
								Mesoderm
							
							Positive
							
								Ectoderm score
							
							Positive
							Differentiation Potency
Microbiology / Virus Screening | 
						|
| Mycoplasma | Negative | 
Genotyping
Karyotyping (Cell Line) | 
					|
| Has the cell line karyotype been analysed? | 
								 Yes 								
																	
															 | 
						
Other Genotyping (Cell Line) | 
					|

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