UK Stem Cell Bank
The UK Stem Cell Bank was established in 2003 to provide quality-controlled, ethically sourced stem cell lines to academic and industrial researchers from the UK and abroad. It is funded by the Medical Research Council and the Biotechnology and Biological Sciences Research Council and is housed at the UK National Institute for Biological Standards and Control (NIBSC).
The Bank is a repository for stem cell lines derived from adult, fetal and embryonic tissues. It operates under accredited quality systems to support the development of research-grade and clinical-grade stem cell lines, and is subject to inspection by the Medicines and Healthcare Products Regulatory Agency under the Department of Health Code of Practice for Tissue Banks. The Bank is staffed by personnel trained to appropriate technical and quality standards, and supported by clinical and scientific advisory groups both inside and outside the NIBSC.
Governance of the Bank
The UK Stem Cell Bank operates in accordance with strict principles of governance laid down by a non-statutory Steering Committee that reports annually to the Medical Research Council and briefs Ministers on request. The Steering Committee is chaired by Lord Naren Patel and includes expertise in obstetrics, surgery, clinical embryology, bioethics, theology, law, stem cell research, midwifery, cell banking and sociology, and two lay members and representatives from the regulatory and funding agencies. A Management Committee for the Bank has been established by NIBSC to deal with operational issues. The Committee is chaired by the Director of the NIBSC and includes in-house and external experts, professionals, lay members and representatives from UK funding agencies. It reports formally to the Steering Committee.
Further detail about the governance structure and committee memberships is available on the MRC website
Codes of Practice
In consultation with a wide range of stakeholders, the Steering Committee has drawn up a Code of Practice for the use of Human Stem Cell Lines. This Code includes interalia route maps to help researchers to identify the licences, accreditations and approvals needed for depositing and accessing banked cell lines; standard IPR agreements; and rules for third party transfers of embryonic stem cell lines to assure traceability.
UK Stem Cell Bank services
The services that the Stem Cell Bank provides to the national and international research community include:
- Providing ethically sourced, quality-controlled stem cell lines, derived from adult, fetal and embryonic tissues, for research and for the development of therapies. In this way, the Bank will reduce the need for individual research teams to generate their own stem cell lines, and in turn reduce the use of human tissues and embryos.
- Ensuring that cell lines which might ultimately provide the basis for clinical therapies are adequately tested for safety and subsequently handled and stored under quality-controlled conditions.
- Providing high-quality starting materials for the development of stem cell therapies.
Although banks for other types of cell lines have been in existence for a while, for example for umbilical cord blood, the UK Stem Cell Bank is the world’s first stem cell bank of its type.
National Institute for Biological Standards and Control
The NIBSC is a publicly funded organisation whose function is to assure the quality and safety of biological medicines such as vaccines and blood products. It works actively within European and international networks to enhance the safety of biological medicines by providing reference materials for assays, by undertaking research on product safety and quality and finally by testing biological medicines prior to distribution and use. It is therefore a natural development for NIBSC to take on the role of establishing and running the UK Stem Cell Bank, thereby helping to ensure that stem cell therapy is developed in an appropriate framework of quality and safety.