Frequently asked questions
What are stem cells?
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.
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Why are they
important to medicine?
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.
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What are stem cell
lines?
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.
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What is the UK
Stem Cell Bank?
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.
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How will it be run?
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
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Why is it being
sited at NIBSC?
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.
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Reasons for
depositing in the UK Stem Cell Bank
- 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.
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How
do I go about depositing a stem cell line in the Bank?
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.
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How do
I obtain stem cells from the Bank?
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.
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How much will it
cost?
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.
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Can the Bank undertake independent research on the stem cell
lines in its care?
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.
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Is the
Bank involved in intellectual property issues?
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.
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How
are IP issues dealt with 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.
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Does
the UKSCB supply stem cells to commercial companies?
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.
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Can the owner of an hESC line or the UKSCB recover costs by
charging for clinical grade cell lines?
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.
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As a depositor, can I access my own cell line from UKSCB?
Yes ; for two purposes :
-
- 1. To confirm that properties of the depositor’s cells have not
been altered by processing at the UK Stem Cell Bank. In this case
the depositor may use the supplied cells solely for the purposes of
confirming the cell lines characteristics and not for
research.
- 2. Supply for the depositor’s existing or new research. In this
case the depositor must :
- a. Submit an application to
access the cell line to the ‘Steering Committee for the UK
Stem Cell bank and for the Use of Human Stem Cell Lines’ (Steering
Committee)
- b. Have obtained an approval
letter from the Steering Committee authorising release of the cell
line to the Depositor.
- c. Sign a [A1] UKSCB
Materials Access Agreement or Research Use License as applicable to
the cell lines in question
- d. Pay all necessary processing
charges and carriage costs levied by the Bank.