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Research Briefing: Stem Cell Research in Context

In the laboratory, stem cells can develop the capacity to reproduce themselves and grow into specialised cells with particular functions, such as heart muscle cells or skin cells. Stem cell research seeks to develop new therapies to
repair damaged tissue and help in finding cures for diseases such as diabetes. There are different types of stem cells: embryonic stem cells, which can develop into many cell types of the human body, and tissue specific ‘adult’ stem cells. Because embryonic stem cells are taken from human embryos, they have been much more controversial than adult stem cells, and also more tightly regulated.

The project:

Different national regimes governing research on human embryos facilitate embryonic stem cell research in the UK and largely restrict it in Germany. While the UK has invested more substantially in embryonic stem cell research, Germany has strongly supported research using adult stem cells. The ‘Stem Cell Research in Context’ project analysed how societal factors such as law and regulation and science policies influence stem cell research in its everyday clinical and laboratory practices, asking:

• How does society, through regulation, science policy and other factors influence the development of stem
cell research?
• What are the similarities and differences between stem cell research practices in the UK and Germany?
• Are there differences in the ways in which social factors shape laboratory versus clinical research?
• What are the challenges of translating potential therapies from bench to bedside?

We conducted ethnographic observations at stem cell clinics and laboratories in both countries, and at more than 40 scientific meetings, and interviewed 80 members of research teams and of regulatory authorities. We compared distinct legislative national contexts, and everyday research practices on human embryonic stem cells and clinical trials for heart repair using patients’ own (autologous) adult stem cells.

About the authors

The authors are members of Egenis, the ESRC Centre for Genomics in Society, which carries out research into the impact on society of new developments in genetic science and technologies. Dr Christine Hauskeller is Deputy Director of Egenis, and researches the interaction between science development in genomics, regulation, and social and ethical
attitudes. Dr Dana Wilson-Kovacs is a Research Fellow currently working on professional roles in biomedical innovation.

Key findings
1) Comparison of the relevant institutional structures, actual clinical and laboratory practices and working environments in the UK and Germany revealed that different socio-political contexts do influence the development of stem cell research and the type of work that is carried out.
2) Regulatory frameworks are an integral part of how clinical staff make sense of what they do. They provide structure and legitimacy to everyday clinical practices. Regulation is not only seen as a bureaucratic and administrative burden, but also as reliable support when it comes to demarcating good research practice.
3) The regulation directs clinical research and fosters collaborations in the production of new therapies. Existing resources are adapted to meet the legislative requirements.
4) Data comparing amounts of research investment funding by country or by type of research are fragmented. More clarity in how the published figures are compiled is needed in order to produce a comprehensive comparative
picture of stem cell funding nationally and internationally.
5) EU legislation, although put into place to integrate and strengthen the bio-economic position of Europe, is implemented differently in each country. Pre-existing institutional structures shape this specific adaptation. The integration of EU medicinal products and tissue and cells regulation into legislative instruments has taken distinct routes in the UK and Germany. The UK has two relatively new regulatory authorities for the regulation of cell therapies (the Medicine and Healthcare Products Regulatory Authority (MHRA), established in 2003, and the Human Tissue Authority (HTA),
established in 2005). Germany has only its federal authorities and the Paul-Ehrlich-Institut, in existence since 1972, which has continually extended its regulatory remit to cover biological and biomedical products. This is vital to the
regulation of clinical trials with adult/autologous stem cells: in the UK there is a question whether clinical interventions using these stem cells are medicinal products (falling under the regulatory authority of the MHRA) or medical procedures (under the jurisdiction of the HTA). In Germany this question does not arise: adult/autologous stem cells are categorised
as medical products and regulated accordingly. In the UK, the uncertainty surrounding the status of adult stem cells has led to ambiguity in the implementation of regulation, which has in turn impacted on the ways in which clinical trials are organised.

Research and regulation
Regulation has overtaken research and is ahead of practice. While research into stem cell therapies for the clinic is still in its infancy, the regulatory practices through which stem cell therapies become certified as therapies have already been implemented. Researchers are encouraged to make the kinds of cells that fulfil the regulatory demands rather than directing their ambition first at developing successful treatments and only later at their safety, accessibility and possible mass production. Regulating products prior to their existence is likely to inhibit the creative development of therapies that may well work in ways that are outside the current regulatory imagination.

For further information visit, or contact:
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By EGenis ,UK.

Health Policy Resource.