The UK Steering Committee which oversees the activities of the UKSCB and the use of human stem cell lines in the UK approves all successful applications to deposit.
Applications to deposit must be submitted to the UK Steering Committee via the MRC Secretariat set up for this purpose and not to the Bank. Details on the application and the supporting information which must accompany the application can be found on the application to deposit form.
The UK Steering Committee encourages the deposition of human embryonic stem cell lines derived outside the UK, as well as somatic stem cell lines derived in the UK or abroad, provided they fulfil the criteria laid down by the UK Steering Committee. Details of the criteria applied by the UK Steering Committee and examples of the types of stem cell line that may be deposited are given in the Code of Practice for the Use of Human Stem Cell Lines.
Subject to the approval obtained by the UK Steering Committee, applicants will need to sign a legal agreement with the Bank and complete cell line related information forms. The Bank regrets it is unable to accept cells for deposition without copies of the appropriate signed documents first having been presented to the Bank. Information on which legal agreement is required can be obtained by contacting UKSCB enquiries.
To avoid delays, potential depositors are advised to review all necessary legal agreements as advised by the UKSCB while their application is being considered by the UK Steering Committee.
It is well recognised that the properties of cell lines may change greatly over extended periods in culture. Large, well-characterised cell banks can capture a single desired cell phenotype and make this available to the researchers allowing them to:
Contamination free cell banks prepared under stringent conditions within a quality framework can also:
Inclusion of your cell line in the UK Stem Cell Bank will:
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.
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.
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).
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.
Failure to sign the MDDA may 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.
The process of accessioning involves:
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.
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. Receiving technical training:
The Bank staff 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 (eg 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 (EUTCD 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.
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.
Once your application to deposit a cell line in the UK Stem Cell Bank has been approved by the Steering Committee, the process of accessioning your stem cell line will begin. The Bank will contact you and ask you to provide technical and other information relating to your cell line. This is collected on our Cell Line Information Form. We will complete the form in conjunction with you and then provided you with the completed form for review and signature. This information will be used to help us to culture and bank your cell line and provide us with the basic information we require to carry out our cell line risk assessment procedures.
A downloadable copy of the form is provided below for information purposes only. It will help you gather the information we require and help speed up the accessioning process. Do not complete the specimen form or return it to the Bank.
Dr Glyn Stacey, Principal Scientist and Head of Cell Biology