How to deposit Stem Cells in the UK Stem Cell Bank
These notes are intended as a step-by-step
guide to depositing human stem cells in the UK Stem Cell Bank.
It is assumed that you will have read the relevant sections of
The Code of Practice for the Use of Human
Stem Cell Lines. The current version of this document is
available on both the MRC’s and the Bank’s websites. It is a
requirement that embryonic stem cell lines derived in the UK under
an HFEA licence are lodged with the UKSCB. Overseas
depositors should also read the sections of the Code of Practice
relating to consent and ethical issues.
Step 1: Complete the application form.
An application to deposit form should be submitted to the
UK Steering Committee through the MRC Secretariat at the
address given below.
The UKSCB is not involved at this stage and to avoid delays, it
is advisable to contact the MRC Secretariat ahead of completing the
application form. They will advise you of any supporting
information that may be required by the UK Steering Committee to
assess your application.
The decision to accept a cell line for deposition into the UKSCB
is made by the UK Steering Committee on the basis of the
application form you provide together with any additional
information requested by it.
Step 2: Contact with the Bank.
Once your application to deposit has been
approved by the UK Steering Committee, the MRC Secretariat will
notify you through its approval letter. This will be copied to the
Bank and you should expect to hear from a member of our team within
the following two weeks.
However, in order to minimise delay, it is
advisable to establish contact with the Bank even before receiving
your letter of approval.
A member of our team will be able to advise
you on relevant legal agreements and other documents specific to
the cell line(s).
Step 3: Complete and sign relevant documents.
Subject to approval obtained by the UK
Steering Committee, you will be contacted by a member of the UKSCB
and you will be presented and asked to sign up to three copies of
the Material Deposition and Distribution Agreement (MDDA). In some
cases additional information specific to the cell line needs to be
captured under a separate technical agreement. All those documents
named above will be provided by the UKSCB in due course.
Failure to sign the MDDA may contribute and
delay the process of distribution of your cell line(s) through the
UKSCB. To avoid delays, you may download and review legal
agreements from the Bank’s website.
Step 4: Formally accessioning the cell line(s) into the
UKSCB.
The process of accessioning involves:
- gathering information;
- receiving technical training (where required);
- identifying a suitable stock of cell material for transfer into
the bank;
- undertaking a risk assessment
Gathering information:
You will need to complete the Bank’s Cell
Line Information Form. It is important that this
information is a correct and up-to-date record of how your cells
are cultured as this document forms the basis for the methods by
which we bank your cell line(s). The form will also become
part of the Cell Line Master File for your cell line: the base
document for Quality Assurance and audit of your cell line.
We will also be asking you for copies of any protocols and
procedures that you may use in order to provide the detail required
for our Standard Operating Procedures (SOPs). All protocols
and procedures you provide will be treated in confidence, but we
would request that you make us aware of any areas that you consider
to be commercially sensitive.
You should complete and check the form carefully, sign and
return the form to the Bank.
Receiving technical
training:
In some cases, the Bank may follow up its initial telephone and
e-mail contacts by visiting your laboratory to talk to you and your
staff in more detail about your cell line. Where appropriate,
the Bank may also make contact with the IVF centres involved in the
derivation of the cell line. The purpose of this contact is to
understand the derivation and initial culture procedures.
Donor anonymity will be respected at all times and the Bank
will seek no information likely to compromise this during such
visits.
We will also discuss with you whether there are any perceived
training requirements for Bank staff and how this may best be
obtained should this prove necessary. In certain
circumstances (e.g. some overseas deposits) it may not be possible
to carry out a laboratory visit. In these circumstances,
the Bank will discuss with you the best course of action to allow
the Bank to gain the necessary expertise.
Identifying a suitable stock of cells
for transfer to the UKSCB:
The Bank only takes in frozen (or vitrified) material.
Ideally, we would like a minimum of six ampoules or straws
all frozen from the same passage. Generally, this should be
from the earliest passage that you believe best represents the cell
line you have derived and which you know is capable of generating a
fresh stock of stem cells. There should also be sufficient
stock from this passage left over for you to archive material
locally for future reference. The material provided should be
from those stocks of cells that were produced and banked under the
protocols and procedures that you supplied to the Bank.
We will also discuss with you whether it would be beneficial to
bank any feeder cells associated with your stem cell line and also,
whether it would be beneficial to receive and test (for sterility
and mycoplasma) some material in advance of your cell line(s)
coming into the Bank.
Undertaking a cell line risk
assessment:
Once the Project the information on your cell line is complete
the Bank will undertake a risk assessment. This will involve
UKSCB staff and advisors and will decide the panel of tests to be
carried out on your cell line(s). The UKSCB undertakes a core
panel of characterisation and safety tests but uses the risk
assessment to generate its full testing strategy. This will
be more extensive (particularly in the area of viral testing) for
cell lines that may have therapeutic potential (so called “Clinical
Grade” cell lines). You, as the depositor, may be asked for
your comments on the testing strategy developed for your cell line
or asked to provide further information.
Step 5: Receiving cells at the Bank.
Prior to taking in the stock of cells, we will discuss with you
the best method of shipping the material to the Bank. This
may involve us in collecting the deposit from you, or arranging for
collection by a third party. In either case, the cost of
transportation will be borne by the Bank.
We may, from time to time during the banking process, contact
you with additional technical questions. Also, if you have
requested it, we will return a sample from our distribution bank to
you for testing. If we find an inconsistency between data you
have supplied and data we have generated during quality control
testing, we will discuss this with you prior to releasing the cells
and placing data on the cell line on our website.
Contact Details
For enquires concerning the application process contact:
MRC general enquires: stemcellsecretary@headoffice.mrc.ac.uk
For all enquires regarding the accession process contact:
UKSCB general enquires: enquiries@ukstemcellbank.org.uk
Signed documents should be returned to:
The UKSCB Business Manager, UK Stem
Cell Bank, NIBSC, Blanche Lane, South Mimms, Potters Bar,
Hertfordshire EN6 3QG, UK.