Stem Cell Research

rose to call attention to the potential benefits of stem cell research and related issues; and to move for Papers The noble Lord said: My Lords, I am delighted that so many distinguished noble Lords will take part in this debate, and I look forward to listening toall the speeches. I am particularly pleased that my noble and right reverend friend Lord Harries of Pentregarth, the former Bishop of Oxford, who chaired the Stem Cell Select Committee, and the noble Lord, Lord Winston, an eminent stem cell scientist, will be taking part. Stem cell research is undoubtedly the most exciting area of biomedical research. What makes it so exciting? Stem cell science has the potential to deliver cures for diseases that were hitherto untreatable, by harvesting the growth of cells and tissues in the laboratory and using them to replace diseased tissues with healthy cells. Regrettably, there has been much premature hype, occasional misinformation and a lack of dialogue between those with opposing views in certain areas of stem cell research. The hope—not hype—is that stem cell research will, in combination with technologies such as tissue engineering, contribute to the fieldof regenerative medicine and help to develop therapies for diseases such as Parkinson’s, diabetes, heart failure, spinal cord injuries, and potentially Alzheimer’s. There are several types of stem cells with varying capacities to give rise to other cell types. The embryonic stem cells, first identified by Sir Martin Evans in 1981, derived from early-phase embryo are the most versatile. Therefore, these cells are often referred to as pluripotent cells. Research on the basic biology of these cells—what regulates them, what programmes their differentiation, what is their behaviour in disease, including cancers, cell death, and so on—will be crucial if we are to find therapies for diseases. Apart from these embryonic stem cells, thereare several types of adult stem cells, which are multipotent and able to give rise to limited numbers of cell types. Such cells are found in bone marrow, blood, cord blood and other sites. Some—for example, bone marrow on rare occasions—have been found to demonstrate pluripotent capabilities. It is true that all the currently available stem cell therapies are based on adult stem cells. Bone marrow transplant started in the early 1970s. Today thousands of such treatments are carried out every year There are other preliminary but none the less exciting developments showing early clinical success, such as eye stem cells for corneal damage, periodontal stem cells for gum damage, bone marrow mesenchymal cells for heart failure, using autologous—the patient's own—stem cells or donor cells from cord blood or bone marrow. Just last week I heard some preliminary successful clinical applications of using autologous stem cells to treat age-related macular degeneration, which affects some 3 million people over the age of60 in the United Kingdom alone. All adult stem cell therapies are patient-specific. Patient-specific treatment is expensive. Scaling up has challenges, both biological and technical. Because embryonic stem cells are easy to culture and keepin a stable undifferentiated form—and therefore potentially capable of mass production, using robotics to do so—they offer potential benefits in treatment on a large scale. Adult stem cells are currently harder to isolate, keep in culture and produce in large quantities. Studies of embryonic stem cells from different species will, in due course, provide better understanding of the factors that control differentiation and proliferation of stem cells, research that will make the wider useof adult stem cells possible. What we already know makes me feel confident that, before too long, the way we treat some diseases today will have changed, using more cell therapy and tissue engineering. It is most important to realise that we need to pursue research on all types of stem cells, and see it as complementary rather than a competing alternative. Adult stem cell research has been going on for decades. Embryonic stem cell research has only been going for the last four years, and even then with a limited number of stem cell lines. None the less, studies on both animal and human stem cells have demonstrated some remarkable advances: stem cells restoring neuronal damage, developing kidneys, developing new neurons and generating pancreatic beta cells that could produce insulin, and reversing Parkinson’s disease damage. In addition, stem cell research has the potential to contribute to drug development, toxicology and immunology—studies with implications for animal and human testing of drugs and transplantation. I shall say a little about the UK’s position in stem cell research and regulation. Before I do so, I declare my interests. I currently chair the Stem Cell Oversight Committee and the Stem Cell Bank committee, the UK National Stem Cell Network and the yet-to-be-funded steering group of the Stem Cell Immunology Programme. I am chancellor of the University of Dundee and vice-president of the Royal Society of Edinburgh, responsible for the section on life sciences. Currently in stem cell research, the United Kingdom is undoubtedly the global leader. What we have put in place is the envy of much of the world, because of strong parliamentary and government support, measured but clearly defined legislation, an appropriate regulatory framework, funding from research councils being matched by charities and, above all, wide public support. In the last MORI poll, 70 per cent of the public supported all forms ofstem cell research. The result has been that the UKhas the world's first and largest stem cell bank, housing ethically sourced, quality controlled, fully characterised stem cell lines. The bank currently holds 40 such lines, and more are in the process of being considered. All will be available for research. We also now have several centres of excellence in stem cell research, far more than any other country in the world, including the United States. We have successfully recruited top stem cell scientists from across the world, including the USA. The United Kingdom punches well above its weight in scientific publications in key journals. Recognising the importance of stem cell scienceto the economy, the Chancellor of the Exchequer, Gordon Brown, commissioned a report from Sir John Pattison, UK Stem Cell Initiative, to set out a 10-year vision on stem cell research to consolidate the UK’s current position and become a global leader in stem cell therapy and technology. The Government accepted the report in full, including all the recommendations, even those related to finance; the Chancellor said so in his Budget speech. So far, it all sounds fantastic. Over the last year, however, we have begun to see evidence of a failureof commitment and mixed messages, particularly on funding for research and regulation from the Government. I will pick up on two key areas of recommendations in the Pattison report, related to funding and timely and judicious regulation. The report includes a chart of the cost of implementing the recommendations over a 10-year period in incremental stages. The total cost over that period is in the region of £630 million. Adding up the funding from both the charities and councils so far amounts to about £40 million up to last year. However, there is already evidence that year-on-year commitment to funding is not being maintained. We are probably already £30 million short of the recommended projection. It is important to note that this is at a time when other countries are scaling up their funding enormously, especially China and the United States of America, where the climate for stem cell research is changing. California alone will spend $300 million per year for 10 years from public funding and possibly $200 million per year from private funding. Other countries scaling up funding are Singapore, India, Australia, Sweden and South Korea. China is likely to outstrip even the USA in research and in facilities related to stem cells. It has state-of-the-art facilities and is recruiting scientists. Biomedical research is seen as a future economic driver. It is important to realise that if we do not keep pace, we will lose momentum and our lead position. We will fail to recruit because all these countries are also trying to recruit. We will fail to develop further capacity. We will fail to train future generations of stem cell scientists. We will fail to translate science into therapy. Worse, we may lose our leaders in stem cell science and the technologies that we have developed. So I hope the Government will commit themselves at least to keeping up funding at the level recommended in the Pattison report and accepted by the Chancellor last year. Let me now turn to regulation in relation to stem cell research. Two areas of regulation need fairly urgent attention. The first relates to the accreditation of good manufacturing practice—GMP—facilities for developing stem cell lines for research and therapy. Just now, there is confusion as to who is responsible for the accreditation of such facilities and the end result is that no regulatory authority is prepared to take it on. We need an authority with statutory responsibility to accredit such facilities. I have yet to be convinced that the new amalgamated HFEA and tissues authority—RATE—will be up to such tasks, but I have no doubt other noble Lords will refer to that. Regulations related to recognising, accrediting and, if required, monitoring GMP facilities for stem cell work are urgent. Let me now turn to regulation related to embryo research. There is much debate and some concern about whether in vitro stem cell research shouldbe allowed on hybrid and chimera embryos. The House of Commons Science and Technology Select Committee, having taken evidence, recommended that such research should be allowed. On the other hand, in the White Paper reviewing the Human Fertilisation and Embryology Act, the Government proposed that the creation of hybrid and chimera embryos in vitro should not be allowed. The HFEA is engaged in a public consultation; I hope it will be a properly informed consultation. The evidence given by research councils and charities to the Science and Technology Committee supported the need for such research. The Academy of Medical Sciences—in which I declare an interest as a fellow—will report and provide evidence to HFEA consultation. It is important to understand what is proposed and why in terms of science. I fully accept that the public must finally decide whether such research should be allowed, not the scientists, so public consultation is absolutely important. What is proposed is using animal ova from cows or rabbits to carry out cell nuclear transfer, in which the nucleus from an ovum will be removed and a human somatic cell nucleus inserted. The resulting embryo in vitro will have99.9 per cent human DNA and 0.1 per cent cytoplasmic—non-nuclear—animal DNA, hence the term cybrids. An embryonic stem cell will be obtained at the five- to six-day stage to develop stem cell lines. The use of animal ova would not be necessary if there was a plentiful supply of human ova, particularly fresh human ova, which there is not. Why do scientists feel that they need this particular aspect of stem cell research? If we are to understand the behaviour and the biology of stem cell lines and develop therapies, it is necessary to develop stem cell lines that carry diseased genes, such as stem cell lines with genetic markers of motor neurone disease, diabetes, cancers and so on. This can best be achieved by using cells from affected individuals and by cell nuclear transfer techniques obtaining embryonic stem cell lines that carry the marker gene, which is a procedure allowed by the HFEA under licence in accordance with current legislation. But to do this in humans has proved difficult—scientists do not understand why—while cloning of embryos has worked in animals. Research on cybrids will allow scientists to learn how to produce disease-based stem cell lines using embryonic stem cells efficiently, or even adult stem cells in the future. Scientists need only a few suchstem cell lines. They will also be important because they will carry disease markers for future drug development. The submission of the Medical Research Council and Wellcome Trust to the House of Commons is detailed and well worth reading. The key elements for the future success of the UK in stem cell research are: strengthening centres of excellence to enhance interdisciplinary and translational research; supporting high-quality clinical studies, which in the near term are likely to be of autologous stem cells, and the stimulation of endogenous stem cells; support for key infrastructure; the integration of biomedical advances with engineering—delivery systems, cell matrices and cell production; the involvement of bioindustry to accelerate therapeutic development; capacity building, including the encouragement of young researchers in related areas of UK strength, such as cancers and developmental biology; a permissive but strictly controlled regulatory structure that both encourages research in this area and reassures the public over ethical and safety issues; and continued international leadership. Therefore, will the Minister emphatically reassure the House that the Government, first, will fulfilthe commitment on funding as recommended in the Pattison report; and secondly, in revising the legislation related to embryo research, will look at the scientific evidence and the wider public opinion and do not intend to bring, even in the interim phase, legislation that damages the current positive environment for stem cell research? I beg to move for Papers.