Stem Cells: Contrasting views from the US and UK at BIO 2005

Human embryonic stem cell (ES cell) research remains front-page news in the US, following the recent vote in favour of liberalising federal funding of ES cell research in the House of Representatives and the forthcoming vote on the same topic in the Senate. Whereas the former bill passed by an insufficient margin to override a Presidential veto, the prospects look good that the bill will achieve the necessary two-thirds majority in the Senate. Despite this, President Bush remains opposed to any change in US policy. This restricts federal funding of ES cell research to a limited number of cell-lines, isolated and maintained prior to 2001 using now obsolete protocols. These relied on animal-based reagents which would, in Europe, preclude the use of any derived materials for human clinical trials. It was therefore not surprising that the BIO 2005 conference (held recently in Philadelphia) featured five panel sessions on stem cell-related issues, of which the highlights were one from the UK titled 'Responsible development of Stem-Cells in Medicine - the UK Approach' and that from California titled 'Stem Cell Research in California - the New Gold Rush?'  

Comments made in the California session were in contrast to the UK panel's view that stem cell derived therapeutics will need to be tested in at least two animal species before conducting clinical trials in the EU. Geron, the leading US company in stem cell research and development, believes that after their recent successes in rodents they will be ready to conduct clinical trials in 2006 - without the need to conduct further animal experiments. The prospects for this strategy met with some scepticism during the question and answer session. Geron may be on track to conduct the first human clinical trial of a human ES cell treatment if their regulatory and development strategies continue to prove acceptable to the US Food and Drug Administration. However, there is considerable debate as to whether these strategies will be more broadly applicable for the development of treatments for much larger numbers of patients, even within the US. The UK's approach of building protocols, infrastructure and capabilities from the beginning will certainly be required to conduct clinical trials in the EU, and may well anticipate the global standards that are likely to emerge in due course.

The California Initiative for Reproductive Medicine (CIRM), the new institution formed to select and monitor programs funded by the state, believes it will shortly resolve both the legal challenges mounted to its fundamental constitution and to its proposed mode of corporate governance - and will therefore be able to start disbursing funds. However, the vast bulk of CIRM funding during its initial phase will be used to build new buildings and labs in which research projects on human ES cells can be conducted without 'contaminating' existing labs receiving federal funding. These would otherwise forfeit funding under President Bush's current guidelines.  It could therefore be quite some time before a significant amount of new research takes place, and the $3 billion investment in California will take longer than expected to have a competitive impact on the UK effort.

The sums of money already invested in the UK and being currently raised are significant but are clearly not yet of the same scale as the $3 billion potentially available to US researchers in California. However the gap may not be as wide, in terms of practical impact, because the UK is a very cost-effective place to conduct research and Britain has invested cumulatively in this field for longer than any other country. As a result the UK research infrastructure is already fully in place so that UK scientists can get straight on with their work, while many US scientists are waiting for their new labs to be built.

The current efforts being made by both the UK Government via the National Stem-Cell Initiative and the UK Stem Cell Foundation to assess what additional resources are required to sustain the UK's strong position in both basic and translational stem cell research are therefore timely. If the opportunity is taken to apply further resources quickly, the prospects for developing new, safe and effective cures and treatments for UK patients and for facilitating the formation of new UK companies and the growth of existing ones remain very promising. In the US, meanwhile, stem cell researchers continue to await the forthcoming Senate debate on ES cell research funding with great interest.