Clinical grade stem cell lines

Clinical grade stem cell lines are suitable for the development of cell therapies and meet the requirements of the European Tissue and Cells Directive (EUTCD)  for the quality and safety assurance of patient treatments. All clinical grade cell lines undergo a process known as Due Diligence, to ensure compliancy with the EU Tissue and Cells Directives (under HTA direction) prior to deposition, and their subsequent banking and distribution for human application. The EUTCD-grade cell lines have been derived from embryos under informed consent requirements of the UK Human Fertilisation and Embryology Authority (HFEA) and have been reviewed by the independent UK Stem Cell Bank Steering Committee (UK Steering Committee)

To obtain human embryonic stem cell lines from the UK Stem Cell Bank, an application to UK Steering Committee must first be submitted and approved. Please follow the guidelines on our page Apply for Stem Cell Lines.

Clinical grade cell lines catalogue

The UK Stem Cell Bank has an ongoing banking program that aims to provide over 20 feeder-free Clinical grade hESC banks with matched-research banks by 2020. 

Below is the Quality Control (QC) information generated by the UK Stem Cell Bank for cell lines available for distribution (bold) or under final review. A Certificate of Analysis is provided with each order. For further details on upcoming cell lines, or those under banking or QC stages please contact enquiries@ukstemcellbank.org.uk.

KCL lines are deposited by King’s College LondonMasterShef lines are deposited by University of Sheffield, Centre for Stem Cell BiologyMAN lines are deposited by University of Manchester. RC lines are deposited by Roslin Cells.

Feeder free clinical grade cell lines

The UK Stem Cell Bank provides clinical grade hESC lines adapted for growth and retention of the undifferentiated state in a xeno-free culture system, without the need for feeder cells.


Cell Line Information
Standard characterisation


Deep Characterisation

             
Cell lineUK steering committee numberMicrobiological safety testingViability and morphologyUndifferentiated cell analysis Differentiation potency STR/HLA profile**KaryotypeCancer panelWhole Genome Sequencing 

Release status

Matched research bank 

KCL-031SCSC12-37

46 XY

Pre-release

KCL-032SCSC12-37

46XX

Pre-release

KCL-033SCSC11-54

✔*

 ✔

46XX

Pre-release

KCL-034SCSC11-54

46XY

Pre-release

MAN-11 
SCSC12-26


 



46XX

Final review

MAN-12
SCSC12-27


 

46XY

Final review
MAN-13

SCSC12-28

46XY

Final review

MAN-14
SCSC14-23

46XX

Final review

MAN-15SCSC14-24

✔*


46XY

Final review 

MAN-16SCSC14-25

✔*


46XY

Pre-release

MasterShef4SCSC12-05

46XY

Pre-release

MasterShef5SCSC12-06

✔*

46XX 

Final review

MasterShef7SCSC12-08

✔*

46XY

Final review

MasterShef11 SCSC13-06

✔*

✔*

✔*

46XY 

 

 

Final review
RC11SCSC11-02

46XX

Pre-release

RC17SCSC12-37

✔*

46XX

Pre-release

Feeder dependent clinical grade cell lines


The UK Stem Cell Bank also provides clinical grade hESC lines for classical, feeder-dependent culture systems. Our cell banks are grown and maintained on quality-controlled primary MEFs, virus and sterility tested, and qualified for viability and stem cell supportiveness.



Cell Line Information
Standard characterisation

Deep Characterisation
             
Cell lineUK steering committee numberMicrobiological safety testingViability and morphologyUndifferentiated cell analysis Differentiation potency STR/HLA profile**KaryotypeCancer panelWhole Genome Sequencing 

Release status

Matched research bank 

KCL-033SCSC11-54

✔*

 

n/a

Special release


MAN-11 
SCSC12-26


 



46XX

Final review

MAN-12
SCSC12-27


✔*

 

46XY

Final review
MAN-13

SCSC12-28


46XY

Final review

MAN-14
SCSC14-23

✔*

46XX

Final review

MAN-15SCSC14-24

✔*


46XY

Final review 

MAN-16SCSC14-25

✔*


46XY

Final review 


MasterShef2SCSC12-03

46XXReleased

 

MasterShef4SCSC12-05

46XY

Final review


MasterShef7SCSC12-08

✔*

46XY

Released

 

MasterShef10SCSC13-05

46XY


Released

 


* Awaiting final review of ongoing viral testing
** 
Human Leukocyte Antigen (HLA) data provided by the Depositor Centre.
*** 
Please Note - EUTCD-Grade cell line MasterShef 10 was produced aseptically in accordance with The Human Tissue (Quality and Safety for Human Application) Regulations 2007 under a licence granted by the Human Tissue Authority. Digital PCR and whole exome sequencing of deposited material identified two TP53 mutations (R248W and G245S). For more information refer to Merkle et al., Human Pluripotent Cells Recurrently Acquire and Expand Dominant Negative P53 Mutations, Nature (2017) doi: 10.1038/nature22312.

In the event of a Serious Adverse Event or Reaction (SAEAR) when using the EUTCD grade cell lines, please contact both HTA and UK Stem Cell Bank within 24 hours. For any uncertainty or clarification on SAEAR please contact us at enquiries@ukstemcellbank.org.uk. For more information about SAEAR please follow HTA instructions.