Frequently asked questions
- What are stem cells?
- Why are they important to medicine?
- What are stem cell lines?
- What is the UK Stem Cell Bank?
- How will it be run?
- Why is it being sited at NIBSC?
- Reasons for depositing in the UK Stem Cell Bank
- How do I go about depositing a stem cell line in the Bank?
- How do I obtain stem cells from the Bank?
- How much will it cost?
- Can the Bank undertake independent research on the stem cell lines in its care?
- Is the Bank involved in intellectual property issues?
- How are IP issues dealt with between depositors and users?
- Does the UKSCB supply stem cells to commercial companies?
- Can the owner of an hESC line or the UKSCB recover costs by charging for clinical grade cell lines?
Stem cells could be described as cells which have not yet chosen a "career path"; and have the potential to become many different types of cell. There are several types of stem cells, some found in the bone marrow are already committed to the "career path" of immune cells but have not differentiated into specific types of immune cell. Others have the potential to become almost any cell in the body (such as cells in early embryonic tissue).
Some stem cells have already been used in medicine for many years. Bone marrow transplants are a long-standing and safe treatment for children with leukaemias and deficient immune systems. They work by seeding the body of the recipient with stem cells which multiply and become the immune cells that the child needs to fight infectious disease.
Stem cells also offer the hope of a cure for many types of disease,
such as insulin-dependant diabetes, Parkinsons disease and tissue damage such as that suffered by spinal trauma victims. Charitable organisations have expressed their support for stem cell research which, they consider, will be of great benefit to the patients they represent.
For more information about some these organisations, click on the following charity logos.
Stem cell lines are stem cells that have been isolated from tissue or blood and held in liquid culture medium under conditions designed to support their growth and proliferation. Under the correct conditions this proliferation enables substantial expansion of the cell numbers.
Following expansion, the stem cell cultures can be harvested, divided into vials and preserved at ultra-low temperatures. This stock of frozen cells is called a cell bank and the freezing process is a crucial stage which enables the cell bank to be stored in a viable and stable state until required. The cells can be thawed and re-cultured for research or therapy. Holding the cells in suspended animation this way also enables extensive quality control and safety testing to be performed before the cells are approved for use.
In some cases, such as embryonic stem cells the cultures appear to have the capacity to expand indefinitely, without changing. Such cell cultures are called stem cell lines.
The bank exists to establish and make available fully characterised and quality-controlled cell banks. These will be supplied to scientific research teams and eventually to pharmaceutical companies, to enable the development of broad-ranging cell therapies. The bank will support the development of stem cell therapy in the UK by:
- Creating and growing a supply of well-characterised stem cell lines for researchers in the UK and abroad. This will allow the research teams to establish the basis for therapeutic applications.
- Creating, a bank of stem cell lines, under conditions consistent for the preparation of pharmaceutical products which provide cultures that could be supplied for the production of medicines for human use.
The UKSCB and its local management committee will:
- Monitor progress of cell bank projects
- Endorse certificates of analysis for cell banks and supporting data
- Apply controls required by Oversight Group and other key organisations
- Where necessary, manage any conflicts or challenges relating to scheduling or other cell bank activities
- Publish an Annual Report
- Develop information strategies for the UK Stem Cell Bank (open forums, publicity, communications etc.)
- Provide advice on new stem cell and related products
The National Institute for Biological Standards and Control (NIBSC) is proud to have been selected as the host for the UK Stem Cell Bank. NIBSC is a publicly-funded scientific organisation whose function is to assure the quality and safety of biological medicines (mainly vaccines and blood products).
Every batch of vaccines used in the childrens vaccination programme in the UK has been tested and approved by NIBSC. All blood-derived products used in the UK are tested at NIBSC for freedom from contaminating viruses such as hepatitis and HIV.
Through its research and development activities it has built up an international reputation, over many years, for its work on the safety and quality of biological medicines such as vaccines and blood products. It also has direct experience of developing and archiving cell lines for clinical applications. Notably, NIBSC established and distributes the MRC-5 cell line that is now in routine use around the world for the production of adult and childhood vaccines. It is therefore a natural development for the Institute to take on the role of establishing and running the UK Stem Cell Bank, and helping to ensure as far as possible that stem cell therapy is developed in an appropriate framework of quality and safety.
NIBSC has a long and distinguished history in the regulation of biological medicines. In the early 20th century UK scientists realised that the strength of certain medicines could only be assayed in relation to a preparation of known strength. One of these medicines was insulin and in the 1920s the very first standard reference material for the assay of insulin was made in the UK. Since then NIBSC has been required to expand the range of products it works on and now occupies a large and developing set of purpose-built labs in Hertfordshire.
In addition NIBSC has long experience in areas of direct relevance to the UK Stem Cell Bank, including the standardisation of cytokines and growth factors. Further standardisation activities relevant to stem cell therapy, include the preparation qualified cell banks and providing an open forum for discussion of quality and safety issues within the organ and bone marrow transplant communities in the UK health service.
NIBSC has a history of successful customer-focused supply of materials to the research community. In addition to its role in ensuring the safety and efficacy of products NIBSC operates as an International repository for several classes of materials.
The Centralised Facility for AIDS Reagents supplies research materials to scientists working on HIV research.
International Biological Standards are the Gold Standards for testing the strength of almost all biological materials and are held at NIBSC and distributed to companies, public health authorities, WHO laboratory networks and researchers world-wide.
Working reagents for use by the UK transplantation laboratories are being developed and supplied by NIBSC, in collaboration with these laboratories.
- Inclusion in an internationally recognised central facility which promotes use of depositors cells and thereby facilitates the possibility of new discoveries with their cells
- UK Stem Cell Bank accession no. is achieved following detailed investigation and assessment and in the future will be a credential for quality in stem cell sciences anf therapy
- Attention from specialist expertise in stem cell culture, preservation and characterisation.
- Provides a quality control and distribution system under internationally recognised quality systems: this represents substantial economies for research networks and start up companies releasing more of their effort space and resources for development
- Early submission will provide confidence: Independent validation of cells in a recognised independent centre
- If cells are submitted early to the UKSCB there will be confidence that problems should not arise after publication and distribution of cells
- That the key critical threats to the eventual use of cells for therapy have been covered at an early stage before a great deal of expenditure has been committed in product development.
Application to deposit a stem cell line in the UK Stem Cell Bank must be made to the Steering Committee for the Bank. Application forms are available on this website and via the link to the MRC website.
The completed application forms together with supporting documentation should be sent to the Medical Research Council who act as the secretariat for the Steering Committee.
NB. The UKSCB system provides protection for depositor intellectual property through a set of three agreements.
Queries regarding availability of stem cell lines may be made directly to the UK Stem Cell Bank or by consulting the relevant page on this website. Requests for permission to obtain stem cell lines must be made to the Steering Committee for the UK Stem Cell Bank on the application form available on this website or from the MRC website via the links page.
The Bank is currently funded via a grant from the MRC and BBSRC which is intended to fund the construction and running costs of the Bank over a 3 year period. The charging regime for stem cells is under review by the funding councils and the Bank. The Code of Practice for the Bank, developed by the Steering Committee, requires that the Bank recover marginal costs from academic users and full costs from commercial users. The purpose of the Bank is to promote research and the development of therapeutic applications. Any charging regime for the Bank approved by the sponsors will reflect this commitment.
Under its Code of Practice, the Bank is prohibited from conducting research that might be seen to produce a conflict of interest between the distribution of stem cell lines and the free dissemination of information available on them. This includes a prohibition on discovery research such as research on fundamental stem cell biology and that which might result in commercial application. The Bank is encouraged to undertake research approved by the Steering Committee on the characterisation of stem cells, on quality and safety issues and on improvements to current processing and storage protocols.
Any intellectual property arising out of the Bank's approved research rests with the MRC during the initial funding phase. Other than this, the Bank will not take any interest in intellectual property embodied in depositing cell lines or become involved in IP negotiations between depositors and users.
A pre-requisite for depositing in the UK Stem Cell Bank is that the owner of the stem cell line signs a Materials Deposition Agreement (MDA) with the Bank agreeing to make the stem cell line available to requestors for research purposes, on terms of access to be negotiated between the depositor and any future requestor in the Materials Use Licence (MUL).
A pre-requisite for approval to access banked stem cell lines is a MUL negotiated between the requestor and the depositor setting out the rights of expectation and ownership of any intellectual property arising out of the research conducted by the requestor. A successful application to the Steering Committee to access stem cell lines will then require the completion of a Materials Access Agreement (MAA) between the Bank and the requestor before cell lines are released. A specimen MAA and guidance on MULs is provided in the annexes that accompany the Code of Practice for the UK Stem Cell Bank available on the MRC website.
The UKSCB provides cells to all named partners in projects approved by the Steering Committee. These partners may include academic, government and commercial organisations. All partners will sign an agreement to receive the cells and this will not permit transfer to other parties without notification.
Any charging policy developed in accordance with the Code of Practice for The Use of Stem Cell Lines (CoP) is advertised on the UKSCB website.
Charging for clinical grade hESC lines is acceptable under the CoP, and charges levied by the UK Stem Cell Bank are described in section 6.6. as follows:
The contract between the funders and the UK Stem Cell Bank makes provision for a schedule of charges for the provision of stem cell lines to users. The Steering Committee has indicated that the charges levied will be different for academic researchers and commercial users of the Bank with commercial users expected to pay the full economic costs. It is also expected that charging for services provided by the UK Stem Cell Bank will be in line with general principles applied by funding bodies and will allow for recovery of some of the operating costs of the Bank over time. A schedule of charges has been established by the Bank, but as of December 2009, no charges other than third party shipping fees, have been levied for research grade cell lines. This situation will be kept under review. An up to date schedule of charges (including shipment charges) as well as notification of any change to the Bank’s policy is available on the UK Stem Cell Bank website.