Policies and guidelines
The field of regenerative medicine is rapidly evolving and whilst it offers great potential for the development of new therapies there is a need to ensure high standards of quality and ethical practice are maintained to uphold public confidence in the field. In order to fulfil the UK Stem Cell Bank’s mission, whilst preserving these high standards, a number of principles and policies have been adopted to guide its operations.
Code of practice for the use of human stem cell lines
Constructed by the UK Steering Committee for the UK Stem Cell Bank and the use of Human Stem Cell lines the code is designed to provide confidence and reassurance to both professionals and member of the public that human stem cell research in the UK is conducted within a transparent and ethical framework. Although the main emphasis of the code is on human embryonic stem cell lines references to stem cell lines derived from other human tissue are included.
The code of practice should be viewed in the context of other codes of practice produced by regulatory agencies such as the Human Fertilisation and Embryology Authority (HFEA), the Human Tissue Authority (HTA) and the Medicines and Healthcare Products Regulatory Agency (MHRA).
Anyone working with human stem cell lines in the UK should use this code of practice, in conjunction with other relevant legislation, to form a baseline of ethical and practical standards for their operations.
Code of Practice for the Use of Human Stem Cell Lines (PDF)
Depositing and accessing lines from the UK Stem Cell Bank
Depositing stem cell lines - All human embryonic stem cell lines or other lines derived from an embryo must be approved for deposit by the UK Steering committee for the UK Stem Cell Bank and for the Use of Stem Cell Lines. Stem cell lines derived from sources other than an embryo (e.g. adult or induced pluripotent stem cell lines) maybe deposited through contacting the UK Stem Cell Bank directly. All deposited lines will be subject to our Materials Deposit and Distribution Agreement.
The National Institute for the Biological Standards and Control is recognised as a depository authority under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure. Human pluripotent stem cell lines may therefore be deposited in the Bank for this purpose. Deposits of this nature will be subject to the WIPO terms.
Accessing stem cell lines - Access to any available human embryonic stem cell lines or other lines derived from an embryo must first have approval from the UK Steering committee for the UK Stem Cell Bank and for the Use of Stem Cell Lines. Stem cell lines derived from sources other than an embryo (e.g. adult or induced pluripotent stem cell lines) may be accessed through contacting the UK Stem Cell Bank directly.
Curation and banking of stem cell lines
A core role of the UK Stem Cell Bank is to act as a custodian for all human embryonic stem cell lines derived within the UK. Under specific circumstances the UK Stem Cell Bank may bank and make lines available for distribution to the regenerative medicine community. This statement covers the criteria applied for determining whether a deposited line will be banked or curated and applies to all human adult, foetal and pluripotent stem cell lines.
Statement on the curation and banking of stem cell lines (PDF)
Induced pluripotent stem cell lines may be offered independently to the Bank (or as a requirement imposed by a funding agency) whilst embryonic stem cell lines must be offered to the Bank through the UK Steering Committee either as a requirement of a UK HFEA license or independently by overseas depositors.
Genetic data
It has been widely accepted that dissemination of scientific data from human genetics research is desirable to coordinate and enhance research. As part of its core remit the UK Stem Cell Bank has been encouraged to facilitate the dissemination of such data and has a responsibility to researchers to make scientific data available on the cell lines it holds.
In November 2015 the UK Stem Cell Bank organised a workshop on the potential impact of the developing EU Directive on personal data protection (coming into force as EU regulation in 2018) and recommendations for best practice in managing genetic data from human cells and cell lines. The report from this meeting is below:
Report on management of genetic data from a workshop held at UKDH 5 November 2015
Charging for access to stem cell lines
In agreement with section 6.6 of the Code of Practice for the Use of Human Stem Cell Lines (2010) and key stakeholders, the UK Stem Cell Bank operates a cost recovery model for access to banked stem cell lines.
The UK Stem Cell Bank will provide academic groups a free vial of feeder cells (either mouse or human) to support the recovery and initial growth of any requested human embryonic stem cell line.
The cost for a vial of a cell line/type (excluding VAT) is summarised in the table below:
|
hESC Research Lines
|
iPSC Research
Line
|
Mouse
Embryonic Feeders
|
EUTCD-Grade Lines
(Tier 1 package)
|
|---|
|
£500.00
|
£500.00
|
£375.00
|
£815.00
|
The UKSCB cost recovery model underwent review in March 2017 and subsequently the charge for research hESC lines increased to £500.00.
Evaluation of hESC lines intended for use as a starting material in the production of cellular therapies
The EU Tissue and Cells Directive outlines the minimum standards which must be adhered to in order to create human embryonic stem cell lines fit for use as a starting material in the development of cellular therapies. This directive is translated in UK law through the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q&S Regulations). The UK Stem Cell Bank only recognises lines which are compliant with the requirements of UK legislation as being suitable for use as starting material for cellular therapies. Lines which meet these requirements are named EUTCD-Grade cell lines by the UK Stem Cell Bank and its partners. The UK regulator, the Human Tissue Authority (HTA), are the responsible authority for the implementation of this legislation and audit all the licensed establishments involved in the process of deriving and banking EUTCD-Grade lines.
In addition to the HTA’s audits, to provide an extra layer of assurance, the UK Stem Cell Bank evaluate all the potential EUTCD-Grade cell lines approved for deposit within the Bank. This process is known internally as “Due Dilligence”. If the line is determined to be EUTCD-Grade a Third Party Agreement (TPA), alongside a deposit agreement, will be put in place and the line will then be subject to the curation and banking policy.