Stem cell banking: A UK perspective on a global challenge …

The UK Stem Cell Bank was established in 2003 to store, characterise and supply ethically approved stem cells for medical research and treatment. It was the first government funded public service collection of stem cells and it has played an important role in developing and maintaining standards in the UK and internationally. So what exactly does it do and why do we need this type of stem cell banking? Glyn Stacey, Director of the UK Stem Cell Bank, tells us more.

In 1998, James Thomson and his research group reported an exciting discovery: they had developed a method to isolate and grow humanembryonic stem cells(human ES cells) in the laboratory. The discovery sparked considerable public interest in the exciting possibilities for use of human ES cells, both in research and in potential medical applications. In the UK the House of Lords organised an open consultation to gather opinions on whether this kind of research should be permitted. The consultation found that people considered the use of human embryos justified in view of the potential for significant public health benefits, provided that such use would be closely controlled. Accordingly, a newAct of Parliament was ratified in 2001, extending the range of research that could be performed on human embryos and making it legal for human embryonic stem cells to be isolated for research. The government made substantial funds available to support such research and announced that a national stem cell bank would be set up to:

The new bank was prohibited from carrying out discovery research into stem cell biology and from close involvement in commercial exploitation, allowing it to maintain an independent role, free of conflicts of interest. As a result, theUK Stem Cell Bank (UKSCB)was founded in 2003 at the National Institute for Biological Standards and Control, with funding from the Medical Research Council and the Biotechnology and Biological Sciences Research Council. It has developed to become a significant component of the UK regenerative medicine community.

Cells taken from a single embryo can be multiplied in the lab to create a cell line able to produce an almost infinite number of embryonic stem cells, all with the same genetic make-up. However, each cell line is different, lines can become contaminated and, even in an uncontaminated line, the cells can change as they divide and multiply over a long period of culturing in the lab. The way a cell line is created can also have an impact on how the cells behave.

With all these factors at play, laboratory centres stem cell banks focused on supplying ethically sourced and quality-controlled human ES cell lines provide important benefits for stem cell research. Standardisation and quality control are essential to allow researchers from different labs to compare their results and to develop safe and effective new therapies. Banking also provides a number of other valuable benefits for the researchers who generate and use cell lines.

The UK Stem Cell Bank is unique internationally because it does not simply bank and distribute a selection of human ES cell lines, but instead it is required by UK regulations to receive and hold samples of each and every line derived in the UK. The Bank has developed an important and well-recognised role in providing support for the UKs regulatory framework for use of human ES cell lines. It also assists those working to translate research developments into clinical applications.

Cell bankingThe Bank currently mainly holds human ES cells. However, it can bank any type of human stem cell line, including those derived from fetal tissue or adult tissue, and it does hold some examples of these. The Bank has also produced new humaninduced pluripotent stem (iPS) celllines and is in the process of accepting new clinical grade human ES cell lines, which meet the tight UK and European regulatory standards required for use of the cells in future therapies for patients. The Bank does not hold stocks of primary human cells such as bone marrow, cord blood or mesenchymal stromal cells for research or clinical applications.

ResearchIn addition to testing, holding and distributing cells, the Bank is involved in a range of UK and international research programmes. Its role in such work is carefully defined and includes banking of cells generated by a research project, qualification of cells and protocols, comparison of different culture and analytical methods. The Bank also carries out internal research to improve the quality of its cells and the scientific data held about them. For example, its researchers have provided independent qualification of protocols for using human ES cells and human iPS cells to make neural (brain) cells for medical research, and have developed new microbial agent detection systems and enhanced cryopreservation methods to reduce contamination and improve storage of cells. In addition to its own research, the Bank provides cells to researchers in industry and academia for a broad range of activities, including development of innovative toxicology tests to improve the safety and cost-effectiveness of new drugs, or development of new cell preservation methods.

Beyond researchThe Banks activities have a far broader reach than simply providing cells for research. It collaborates with researchers and regulators to find solutions to regulatory challenges for the use of stem cells in medical applications, makes significant contributions to the development of international standards for stem cell culture and characterisation and helps develop best practice in construction and operation of stem cell facilities. The Bank also plays an important role in training researchers. Culturing human ES or iPS cells in the lab remains technically challenging. The combined experience of the Banks staff allows them to offer valuable advice and training that enables researchers to select the most suitable cell lines for their work and facilitates start-up of new projects or entry of new researchers into the stem cell field.

Stem cell research is a global activity and stem cell banking is an important topic not only in the UK, but all over the world. The UK Stem Cell Bank has been active internationally, supporting UK representation in international policy discussions and making regular contributions to training courses outside the UK, for example in India and the USA. Indeed, the Bank has established formal agreements to collaborate in the USA, Spain, China and Korea, focusing on dissemination of its expertise, joint training for researchers and collaborative research activities.

Many countries are building stem cell banking programmes and there are a number of international banking initiatives. Examples of projects the UK Stem Cell Bank has been involved in include:

Induced pluripotent stem cells were first created in 2006 by Professor Shinya Yamanakas research group in Japan. Their revolutionary technique for converting specialised cells from adult tissues, such as skin cells, into cells with the properties of human ES cells has had a huge impact on the stem cell field. iPS cells are now studied all over the world and this has driven a series of large human iPS cell banking programmes in the USA, Japan and the UK. It is a significant challenge to develop large collections of iPS cell lines, while maintaining the cell and data quality necessary for high-level research. New cell culture techniques and approaches are needed, as well as methods for rapid characterisation of the cells to provide the necessary data on the exact nature of the cells that are being grown and banked.

The availability of stem cell lines of all types, with different characteristics, genes and disease associations, is fundamentally important for the future of biomedical research. As researchers understand more and more about stem cells, their use in areas such as cell therapy, the study of genetically-inherited diseases and safety testing of new medical products will expand. They will also find new applications in research areas such as human developmental biology, infectious diseases, and the study of how our bodys tissues and organs develop. Whilst routine clinical use of human ES or human iPS cells lines is some time away, several early stage clinical trials using human ES cells are already underway. Nevertheless, there is still much to be understood about stem cells and how to use them safely and effectively in humans. The dynamic field of stem cell research shows no signs of losing momentum and stem cell banks will be in increasing demand as the number of researchers working on stem cells increases and new applications are investigated. Stem cell banks will have a serious responsibility for preventing the repeat of past problems, where cells lines have been mixed up or contaminated with microbes, leading to publication of misleading research findings. In addition, stem cell banks will need to play a role in ensuring that any cells used in research have been sourced ethically - an important issue in sustaining public support for stem cell research in general.

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Stem cell banking: A UK perspective on a global challenge ...