The Role of the UK Stem Cell Bank.
The UK Stem Cell Bank was established to provide a repository of hESC lines as part of the UK governance for the use of human embryos for research. Its role is to provide quality controlled stocks of these cells that researchers worldwide can rely on to facilitate high quality and standardised research. It is also ready to prepare stocks of ‘clinical grade’ cell lines as seed stocks for the development of therapies.
The UKSCB now holds non-hESC lines, leads in the development of best practice for the operation of banks of stem cell lines, and maintains an active engagement with the broader stem cell research community through its national and international collaborations. Through these activities the Bank is also developing expertise that is enabling it to play an important role in providing advice on the scientific and technical aspects of delivering cell therapies.
The role of the UK Stem Cell Bank is delivered through a high level strategy document.
Overview
NIBSC and the UK Stem Cell Bank
NIBSC is a government-funded organisation involved in quality assurance and research related to biological medicines. It works actively within European and International networks to enhance the safety of biological medicines through the provision of reference materials for assays, by development of underpinning research on product safety and quality and finally by batch-release testing of products.
In September 2002 NIBSC was selected to host the new UK Stem Cell Bank funded by the Medical Research Council (MRC) and the Biotechnology and Biological Sciences Research Council (BBSRC). The UK Stem Cell Bank provides a repository for human stem cell lines of all types, and has been developed to supply well characterised cell lines under appropriate and accredited quality systems both for basic research and for the development of clinical applications.
The Bank is more than a repository for stem cell lines. It is a principle of the Bank that its research should not conflict in any way either with the academic sector, or with commercial companies. As a governing principle, in order to avoid conflicts of interest, the Bank does not engage in research into basic stem cell biology nor undertake near market, commercial research. Research is restricted to areas relating to improving cell culture, preservation, cell characterisation and safety testing.
Governance of the UK Stem Cell Bank
The Bank operates in accordance with strict principles of governance laid down by a high level committee, chaired by Lord Patel, known as The Steering Committee for the UK Stem Cell Bank and the Use of Stem Cell Lines (the Steering Committee) for which the MRC acts as the secretariat.
The Bank reports to and is overseen by the Steering Committee. In addition the Bank operates under a Code of Practice drawn up by the Steering Committee, which is in addition to the regulatory framework provided by EU cGMP and other EU Directives.
A Management Committee, with lay representation as well as representatives from research, healthcare, the regulatory bodies and the Bank’s sponsors, monitors the Bank for adherence to the Code of Practice and assists in the Bank's strategic development. More detailed information regarding governance can be found in The Code of Practice for the Use of Human Stem Cell Lines.
The Bank and Stem Cell Research
Stem cell research offers enormous potential for major advances in clinical therapy. Stem cells could be used to replace missing or damaged cells in important diseases, such as Diabetes and Parkinson’s, and in the treatment of traumatic injury including paralysis.
The establishment of the UK Stem Cell Bank is an important step along the way to realising this potential and offers a vital resource to support the advance of research in this exciting area. At the same time we are developing important safeguards, by ensuring that cell lines which could ultimately provide the basis for clinical treatment are handled and stored under properly controlled conditions and undergo stringent safety and quality control testing.
By providing high quality starting materials to facilitate the development of stem cell therapy, and acting as a centralised resource for researchers, the UK Stem Cell Bank should reduce the demand for surplus embryos to be used for the development of stem cell lines.
Importantly, the establishment of the UK Stem Cell Bank should not be seen as an end in itself. In a government review of stem cell research in the UK published in 2005, Sir John Pattison identified the Bank as a key element in the development of the UK initiative. Instead, it represents a vital element in the development of stem cell therapy as a whole. Ultimately success will benefit from a partnership approach, and NIBSC and the UK Stem cell Bank are committed to working closely with researchers, clinicians, funding bodies, industry and regulators, to bring this major opportunity for improving human health to fruition.
Cell banks are already in existence for many other types of cell line, but this MRC initiative, co-sponsored by BBSRC and with the full backing of the UK Government, is the world’s first Stem Cell Bank of its type and reflects the UK’s leading position in this exciting area of science.
Establishing the UK Stem Cell Bank
Following reports into stem cell research by the Chief Medical Officer and the House of Lords Select committee in 2002, the bank was established with a £2.4M grant from the MRC and BBSRC in January 2003. Information on Phase I of the Bank’s development can be found in the Progress Report and Annual Reports provide by the Bank to the Steering Committee and which are available below.
Progress report
UK Stem Cell Bank Progress Report 2003-2005
Annual Reports
- 1st Annual Report 2004
- 2nd Annual Report 2005
- 3rd Annual Report 2006
- 4th Annual Report 2007
- 5th Annual Report 2008
- 6th Annual Report 2009
The Future of the UK Stem Cell Bank
Between July and December 2005, the Bank presented its case to the MRC and BBSRC for continued funding. Based on the success of Phase I, the Bank proposed expansion of cell banking and the development of the Bank as a resource for stem cell research and clinical therapy both for the UK and internationally. A full business case, options appraisal and feasibility study was undertaken and submitted along with a proposed development plan for the period 2006 – 2010. The proposals were whole-heartedly endorsed both by the reviewers and the MRC and BBSRC committees dealing with the application. Final approval was received from the MRC Council in December 2005. The Bank received in full its request for £9.4m to build, equip and run a new permanent UK Stem Cell Bank and develop the activities detailed in the plan available below.