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
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 London. MasterShef lines are deposited by University of Sheffield, Centre for Stem Cell Biology. MAN lines are deposited by University of Manchester. RC lines are deposited by the University of Edinburgh.
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 Line
|
Feeder Status
|
UK Steering Committee Approval #
|
UK Stem Cell Bank Accession Number
|
Karyotype
|
OncoPanel Testing
|
Whole Genome Sequencing
|
Clinical Release Status
|
Research Release Status
|
Cell Line Information
|
|---|
| KCL032 |
Feeder Free |
SCSC11-58-(d) |
C-16-012 |
46XY(30) |
Tier 4
|
✔ |
Released
|
Released |
X
|
| 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. |