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Standards in stem cell research help both scientists and regulators to manage uncertainty and the unknown, according to new research funded by the Economic and Social Research Council. Efforts to standardise practices across different labs is, however, a balancing act where the autonomy of scientists and fragility of living material need to be weighed against the need for comparable data.

The ambition in many quarters to scale up the production of human embryonic stem cells and move towards clinical trials requires that different laboratories are able to produce to a standard quality of cells. Developing common standards in stem cell production is not straightforward as so much is still unknown in this new science.

Professor Andrew Webster and Dr Lena Eriksson of York University interviewed and observed a range of scientists and technicians working in stem cell laboratories in the , and .

Accurately describing human embryonic stem cell lines is one way to begin setting standards. A stem cell line is a family of constantly-dividing cells, the product of a single parent group of stem cells. Embryonic stem cells are unique in that they have yet to 'decide' which developmental path to choose: they have the ability to turn into almost all human cell types. However each human embryonic stem cell holds the genetic signature of the donor which differs between donors just as people themselves differ. Further the state of a stem cell is by its very nature temporary as it is defined by its ability to develop into many different cell types.

Some scientists argued that as the stem cell cannot be standardised, the process and materials used should be standardised. Currently differences in laboratory practices are thought to result in differences in stem cell lines reflecting the way they are treated rather than an innate quality of the lines themselves. The skills of the laboratory technician also play a key role. But pinpointing all the factors that contribute to producing successful stem cell lines remains elusive. “Scientists often explain that their laboratory produces successful human embryonic stem cell lines because their laboratory uses the factor X when they grow them or its lab technicians have green fingers,” says Dr Lena Eriksson of the research team.

Some researchers prefer not to develop standards as these will constrain the science and may close off promising areas of research. “Others argue that it is simply futile,” explains Lena Eriksson. “Can you standardise how all children sleep by giving them the same bed, sheet and blanket? Of course not. So why bother standardising the materials of stem cell production when other differences such as donor history and derivation methods are so complex, manifold and, to date, largely unknown?”

However, the research shows most stem cell scientists are keen to collaborate on the technical side as they feel this is necessary in order to move the field as a whole forward. The research team followed one particularly successful effort – the International Stem Cell Initiative – that adopted a multi-sited experimental approach in which a large number of stem cell lines were analysed and compared.

Because of the imprecise nature of the manual laboratory work, standardisation opens a potential market for automation technologies to be introduced into human embryonic stem cell laboratories. Yet the research shows this also brings tensions. By attracting businesses keen to become suppliers of laboratory material for this emerging market, the expense of such equipment as well as the skills and staff needed to operate it may exclude small laboratories. Even those that can afford to meet the costs have reservations about the robustness of stem cells to withstand the automation process. The relationship between standards, automation and stem cell quality will be key to the future scale-up of the field and so its clinical application.

FOR FURTHER INFORMATION, CONTACT:

Professor Andrew Webster on Tel: 01904 43 3041; e-mail: ajw25@york.ac.uk

Dr Lena Eriksson on Tel: 01904 43 4742; e-mail: le502@york.ac.uk

ESRC Press Office:

Kelly Barnett on Tel: 01793 413032, e-mail: kelly.barnett@esrc.ac.uk

Danielle Moore on Tel: 01793 413312; e-mail: danielle.moore@esrc.ac.uk

NOTES FOR EDITORS:

1. The research project ‘Quality Assured Science: The Role of Standards in Stem Cell Research’ was funded by the Economic and Social Research Council. It was carried out by Professor Andrew Webster and Dr Lena Eriksson of York University together with Professor Peter Andrews and Professor Harry Moore of Sheffield University. The project is part of the ESRC’s Social Science Stem Cell Initiative set up in 2005. More at: http://www.york.ac.uk/res/sci/introduction.htm

2. Methodology. The project consisted mainly of ethnographic work, participant observation and both formal and informal interviewing. The research took place at a range of locations including the Centre for Stem Cell Biology in Sheffield, the UK Stem Cell Bank, the Thomson Lab at the University of Wisconsin, the Melton Laboratory at Harvard University, the US Stem Cell Bank and two different laboratories in .

3. The Economic and Social Research Council (ESRC) is the 's largest funding agency for research and postgraduate training relating to social and economic issues. It supports independent, high quality research which impacts on business, the public sector and the third sector. The ESRC’s planned total expenditure in 2008/09 is £203 million. At any one time the ESRC supports over 4,000 researchers and postgraduate students in academic institutions and research policy institutes. More at http://www.esrcsocietytoday.ac.uk

4. ESRC Society Today offers free access to a broad range of social science research and presents it in a way that makes it easy to navigate and saves users valuable time. As well as bringing together all ESRC-funded research and key online resources such as the Social Science Information Gateway and the UK Data Archive, non-ESRC resources are included, for example the Office for National Statistics. The portal provides access to early findings and research summaries, as well as full texts and original datasets through integrated search facilities. More at http://www.esrcsocietytoday.ac.uk

5. The ESRC confirms the quality of its funded research by evaluating research projects through a process of peer review. This research has been graded as ‘Good’.

6. 18th July 2008: Health Minister joins ESRC Egenis researchers for public meeting. Join Health Minister Ben Bradshaw MP and researchers from Egenis at a public meeting to debate stem cell and embryology research. The ESRC Centre for Genomics in Society, to offer the public the chance to ask questions and to debate the issues. On the panel for the ‘Question Time’-style event, which will begin at 7.30pm, will be Mr Bradshaw, who is MP for Exeter, Director of Egenis Professor John Dupré and Senior Research Fellow Dr Christine Hauskeller, and Clinical Oncologist Dr Liz Toy of the Royal Devon & Exeter NHS Foundation Trust.