As part of an MRC funded project a number of human embryonic cell lines were derived with the intention for use as a starting material in the production of cellular therapies. These lines are at various stages of our process and an update on their current status can be found here:
Cell Line Due Diligence Review: Status Update, June 2018
Background – In 2007 the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q&S Regulations) were enacted which fully implemented the EU Tissue and Cells Directives into UK law. These set out to create a harmonised approach to the sharing of tissues and cells across Europe but importantly set a benchmark in standards which must be met when procuring, testing, processing, storing and distributing embryonic stem cell lines intended for the use as starting material in the development of therapies. Following on from this a programme of work began to ensure that a panel of hESC lines were created to meet these new standards and provide an invaluable resource to the UK and international stem cell community.
Due Diligence - This is the process whereby the UK Stem Cell Bank (UKSCB) ensures that a cell line approved for human application by the UK Steering Committee meets the requirements of the UK Regulator, the Human Tissue Authority (HTA), Directions in respect of the Human Tissues (Quality and Safety for Human Application) Regulations (2007). The Due Diligence review is based on an assessment of the information supplied to the UKSCB by the Depositor.
Following this review process these cell lines may then be banked at the UKSCB in compliance with HTA Directions enabling them to be released as EUTCD-Grade cell lines. Designated EUTCD-grade cell lines are provided as starting materials only and their use by the user will still require careful review including a risk assessment of the cell line’s suitability for the user’s intended purpose together with an appropriate programme of risk management and risk reduction.