Human stem cell research gets green light

LONDON — Two research groups in the UK have been granted the first licenses to proceed with programmes designed to develop human embryonic stem cell lines, after new regulations were introduced last week to govern this area of research.The UK Human Fertilisation and Embryo Authority (HFEA), the regulatory body that oversees human fertilization and related research in the UK, approved applications from two research groups to develop stem cell lines from human embryos. Previously, researchers in the UK were allowed only to work with human fetal cells or blastocysts in research directly related to improving the management of infertility, and were not allow to culture embryonic stem cell lines for a prolonged period.A group at Edinburgh University has been licensed to develop embryonic stem cell lines to be used in studies designed to develop new therapeutic approaches to Parkinson's disease, and a team at King's College London has been approved to use stem cells to investigate blastocyst development and stem cell lines for diabetes and Parkinson's disease. The HFEA said that its license committee gave "careful consideration to the scientific, medical and ethical issues of the applications." Licenses were granted for development of stem cell lines only from 'spare' embryos created for infertility treatment, where prior informed consent had been given by patients.The granting of the research licenses followed two days after the approval last week by the House of Lords Select Committee on Stem Cell Research to extend research uses of human embryos to allow embryonic stem cell research. The Committee recommended: "There is a clear scientific case for continued research on embryonic stem cells, in order that the full potential of adult stem cells for therapy can be realised and because it is likely that some therapies will need to use embryonic stem cells." Previously, stem cell research had focused on embryonic stem cells from animals or on adult stem cells. "For the full therapeutic potential of stem cells, both adult and embryonic stem cells, to be realised, fundamental research on embryonic stem cells is necessary, particularly to understand the processes of cell differentiation and dedifferentiation."The move has made the UK regulations on embryonic stem cell research and human cloning more wide-ranging than in other countries and has received widespread support from the scientific community. George Radda, Chief Executive of the Medical Research Council (MRC), said: "The MRC supports this area of research and believes that it has real potential for the treatment of many life-threatening diseases and conditions." The MRC has set up a committee to develop principles and practice in relation to the ethical, legal and regulatory issues associated with stem cell research and banking. The UK researchers argue that the ability to develop human embryonic stem cell lines is essential to make progress in the medical use of cell technology. One of the new license holders, Stephen Minger, lecturer in biomolecular sciences at the School of Biomedical Sciences, King's College, London, explained: "Embryonic stem cells are useful because they are very primitive — they have the potential to develop into any type of cell in the body. We have to work out how to coax them to develop into specific types of cells." The handful of human embryonic stem cell lines that have been generated have not been made available to the wider scientific community, Minger said. "To the best of our knowledge, there have been no well-characterised human stem cell lines grown successfully in this country." He added: "Our study aims to address some of these issues whilst also providing basic embryological data of clinical significance, which will impact on working practice."The King's College researchers plan to look at three main applications of human embryonic stem cells. First, they will investigate the properties that make some blastocysts more successful than others, by generating embryonic stem cell lines and then looking back at cytogenetic measures of blastocyst quality. Second, they plan to explore the best ways of generating human embryonic stem cells from blastocysts. Finally, they will try to develop different cell lines from clonal lines of human embryonic stem cells with the ultimate aim of being able to use these cells therapeutically. Minger explained: "Our major interests are initially diabetes and Parkinson' disease, because there is good human transplant data that inserting new islet cells or new dopamine-releasing cells, respectively, works. But there is a shortage of human cells. If we can generate these cells from human embryonic stem cells, these could — in the future, although our license does not cover this — be used therapeutically."Austin Smith, director of the Centre for Genome Research, University of Edinburgh, and member of the second group licensed, said: "Research into stem cells is vital to evaluate their potential use in the development of new medical treatments for a range of degenerative and chronic diseases which are otherwise untreatable, or poorly treated. Of particular interest are Parkinson's, stroke and cardiovascular diseases." He added: "The objectives of our research are to develop the best methods for cultivating stem cells and for directing them to make nerve, heart and blood cells." Any stem cell lines that the group derives will be deposited in the new national stem cell bank that is being established by the Medical Research Council.The day after the UK regulations were announced, the National Institutes of Health issued a document clarifying strategies for implementing human embryonic stem cell research in the US. The strategies are designed to integrate the policy for human embryonic stem cell research announced last year by President Bush into the research structure of the NIH. Under this policy, US researchers funded by the NIH can only use existing human embryonic stem cell lines approved by the government.The NIH has included basic research in its priorities for work on stem cells. The statement argued: "Given that fewer than two dozen scientific publications currently exist using these cells, most scientists agree that a substantial amount of basic research is needed before human embryonic stem cell-based therapeutic technologies can prosper." Over the next few months, NIH will be releasing requests for proposals that define "programmatic areas of interest and relevant funding opportunities." To help researchers apply for grants to work on human stem cell lines, the NIH has developed a website to give investigators information on specific cell lines. It recognizes, however, that the supply and distribution of human embryonic stem cells to NIH-funded investigators could be difficult so plans to provide support to sources of human embryonic stem cells for the scaling-up of cell production.The NIH recognizes that there are practical and administrative issues that need to be resolved in order to improve research with human embryonic stem cells in the US. In an effort to overcome the lack of practical experience with human embryonic stem cells, it is planning workshops to bring together researchers working in genetics, proteomics and developmental biology with scientists who have technical expertise with human embryonic stem cells. On the administrative side, the NIH has suggested that supplements for existing grants in related stem cell or developmental biology is one approach that could speed up the expansion of human embryonic stem cell research experience. "Our goal is to provide some options to catalyze the scientific community's research in this exciting new field."For now, Minger — who comes from the US but now works in London — welcomes the clarity of the regulations on human stem cell research in the UK. "The guidelines are crystal clear. It is very clear what we can and can't do. If you want to do research with human embryos and stem cells you have to get a license from the HFEA and follow their regulations. These combine the opportunities to develop good science with respect for issues of ethics and patient confidentiality."

Human stem cell research gets green light

The first UK licenses for human embryonic stem cell research have been granted.

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