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.

* Please Note – MasterShef10 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 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 follow HTA instructions.