Clinical grade stem cell lines

Clinical grade stem cell lines are suitable for the development of cell therapies and meet the requirements of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) 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 Clinical-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 enquiriesmail@mhra.gov.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.

In the event of a Serious Adverse Event or Reaction (SAEAR) when using the Clinical-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 enquiriesmail@mhra.gov.uk. For more information about SAEAR please see Human application serious adverse event and reaction (SAEARs) reporting | Human Tissue Authority.



Cell Line Information
Deep Characterisation
Availability
Cell LineFeeder StatusUK Steering Committee Approval #UK Stem Cell Bank Accession NumberKaryotype OncoPanel TestingWhole Genome SequencingClinical Release StatusResearch Release Status 

Cell Line  Information

KCL031 Feeder Free SCSC11-58-(d) C-16-011 46XY Tier 4 Final review Released X
KCL032 Feeder Free SCSC11-58-(d) C-16-012 46XX Tier 4 Released Released X
KCL033 Both SCSC11-54 C-16-013 46XX Tier 4 Final review Released X
KCL034 Feeder Free SCSC11-54 C-16-014  46XY Tier 4 Final review Released X
KCL037 Feeder Dependent
SCSC11-58-(d) C-16-015 46XY Tier 3 Final review Released X

XMAN-16 Feeder Free SCSC14-25 C-16-008 46XY Tier 4 Final review Released X
MasterShef02 Feeder Dependent SCSC12-03 C-14-021 46XX Not available

X Final review

Released More information

MasterShef04 Feeder Free SCSC12-05 C-14-023 46XY Analysing Final review Released More information
MasterShef07 Feeder Dependent SCSC17-20 C-16-019 46XY Tier 4

Final review Released More information
MasterShef11  Feeder Free SCSC13-06 C-16-021 46XY Tier 4 Released Released More information
RC11 Feeder Free SCSC11-02 C-18-038 46XX Tier 4 Released Released More information
RC17 Feeder Free SCSC11-38 C-18-044 46XX Tier 4 Released Released More information



Tier 1                                            The alteration has well-established published evidence confirming clinical utility in this tumour type, in at least one of the following contexts: predicting response to treatment with an FDA-approved therapy; strongly supportive in establishing a definitive diagnosis; assessing prognosis; or conferring an inherited increased risk of cancer to this patient and family.
Tier 2 The alteration may have clinical utility in at least one of the following contexts: selection of an investigational therapy in clinical trials for this cancer type; limited evidence of prognostic association; supportive of a specific diagnosis; proven association of response to treatment with an FDA-approved therapy in a different type of cancer; or similar to a different mutation with a proven association with response to treatment with an FDA-approved therapy in this type of cancer.
Tier 3 The alteration is of uncertain clinical utility, but may have a role as suggested by at least one of the following: demonstration of association with response to treatment in this cancer type in preclinical studies (e.g., in vitro studies or animal models); alteration in a biochemical pathway that has other known, therapeutically-targetable alterations; alteration in a highly conserved region of the protein predicted, in silico, to alter protein function; or selection of an investigational therapy for a different cancer type.
Tier 4 The alteration is novel, or its significance has not been studied in cancer. A subset of these alterations likely represents normal germline variants as the assay is not analysed in conjunction with a matched normal from the same patient.