Due diligence is the process whereby the UK Stem Cell Bank 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 HTA Regulation 2007 (as amended). The Due Diligence review is based on an assessment of the information supplied to the UK Stem Cell Bank by the derivation centre.
In 2007 the Human Tissue (Quality and Safety for Human Application) Regulations 2018 (as amended) 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 that 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 EUTCD-grade human embryonic stem cell lines were created to meet these new standards and provide an invaluable resource to the UK and international stem cell community.
Under MRC funding, several human embryonic cell lines were derived in the UK with the intention for use as a starting material in the production of cellular therapies. These lines are at various stages of the UK Stem Cell Bank Due diligence process and an update on their current status can be found here: Latest Due Diligence Update [DOC].
Following the UK Stem Cell Bank review process these cell lines may then be banked in compliance with HTA Directions enabling them to be released as Clinical-grade cell lines. Designated Clinical-grade cell lines are provided as starting materials only and their usage will require further review by the end user, including a risk assessment of the cell line’s suitability for the intended purpose together with an appropriate programme of risk management and risk reduction.