Former drugs tsar to head new stem cell body; Macauley leads Branson foundation

Stem Cell Technology vital for a Smart, Successful, Scotland  

Scotland's Health, Holyrood Magazine, April 2006

Just last month the UK Stem Cell Foundation received a significant grant from Scottish Enterprise to establish an Edinburgh office. It seems only fitting therefore to take this opportunity to discuss the importance of stem cell technology for the health and wealth of Scotland and the many strategic initiatives which the Scottish Executive is pursuing to bolster Scotland’s position as a global leader in Stem Cell research.  

As we live longer the pressure to tackle persisting threats to global health becomes increasingly acute. The incidence of degenerative diseases including Parkinson’s, Alzheimer’s, diabetes and arthritis is rising and we have yet to develop any suitable means of treatment or cure. Diabetes alone affects one in ten people over the age of 64 in Scotland and currently demands 5% the NHS treatment budget. This figure is expected to treble over the next five years. We have a fundamental social and economic responsibility to address these ailments for the benefit of millions of people across the globe.  

Stem cell research is medicine’s brightest hope for finding a cure to these devastating diseases. Complex problems require sophisticated science and it is stem cell technology that is currently pushing the frontiers of scientific research. Stem cells have the remarkable ability to self renew and to differentiate into all the tissues which make up the human body. These two biological properties provide us with the potential to repair or replace the insulin cells in diabetes patients, the musculoskeletal cells in those with arthritis and the neuronal cells in patients suffering from Alzheimer’s or Parkinson’s. If scientists can decipher the chemical reagents and conditions required to initiate particular changes in stem cells then there is even the possibility that we will be able to grow whole organs in the laboratory for transplantation.  

The UK Stem Cell Foundation was established specifically to fund ‘translational’ stem cell research which aims to move stem cell techniques into clinical practice. Too many of the UK’s groundbreaking scientific research papers are published and filed without appropriate consideration for their medical and commercial prospects. Funding bodies are thought to contribute heavily to this trend, favouring low-risk, hypothesis driven research. It is vitally important that we support those who are pioneering the clinical application of stem cell technology and it is for this reason that the Foundation supports promising stem cell research with a focus on near-term patient benefit.  

The Scottish Executive has rightly identified the development of stem cell technology as an ‘overarching priority’ for future economic success. Edinburgh currently boasts Europe’s largest stem cell community and is home to two of the most prolific Centres of Excellence in the world, the Roslin Institute and Edinburgh University’s Institute for Stem Cell Research (ISCR). The former is best known as the birthplace of ‘Dolly’ the sheep and according to the recently published UK Stem Cell Initiative generates the highest number of stem cell patents in the UK. The latter created the world’s first clutch of nerve stem cells last August, a breakthrough in the search for treatments for Alzhiemer’s and Parkinson’s. Scotland clearly enjoys a position of strength in stem cell research and must exploit this unique opportunity if it is to retain its competitiveness in an increasingly knowledge driven global economy.  

ITI Life Sciences, a strategic initiative launched by Scottish Enterprise in 2004 to increase competitiveness in the life sciences sector estimates that the market value for stem cell therapies is approximately $3 billion and will grow by at least 25% per year through 2010. There are also attractive and viable markets to be realised in the short term for those providing biological and technological products to support advancing stem cell therapies and for the role of stem cells in the development of new pharmaceuticals.  

For instance, just last month Stem Cell Sciences plc, one of two UK publicly listed stem cell companies, launched the ESGRO Complete product line. This is the first clinically validated medium permitting large-scale consistent production of mouse embryonic cells for use in world-wide research. There is a burgeoning market for these ‘auxiliary’ product lines including other growth reagents, stem cell cultures and cell separation and mass production technologies.  

Stem cells can also be used as a valuable tool for drug discovery. For example, testing the effect of new chemical compounds on nerve stem cells may provide an insight into alternative treatments for Alzheimer’s.  This should reduce the time taken to bring new pharmaceuticals to market by speeding up the pre-clinical trial stage. It may also serve to decrease the number of animals required for essential pre-clinical toxicity tests.  

If Scotland maintains its commitment to advancing stem cell research then it could be the start of a global industry centred in Scotland which not only taps into potential new therapies but also supporting markets. Any bid for supremacy however will not go unchallenged. The immense potential to be realised in the expanding biotech sector and in particular in stem cell technology is widely acknowledged. The US, Canada, Japan, China and Singapore are all actively pursuing stem cell innovations.  

South Korea is also considered to be a leading light in the field, renowned for the vast amounts of public funding dedicated to research. However, the recent fall from grace of their most esteemed stem cell expert Hwang Woo Suk, amid charges of scientific fraud and contraventions of global ethical standards, has left a cloud over the South Korean stem cell community which will take some time to disperse.  

This incident has not, as some people have claimed, undermined the credibility of stem cell research internationally. If the actions of a lone practitioner served to undermine an entire medical community then stem cell research would be far from the only practice left scarred. However, it does bring back into sharp focus the importance of ensuring adherence to professional and ethical standards.  

Researchers in the UK operate within the strict regulatory code laid down by the Human Fertilisation and Embryology Authority (HFEA) and the EU Tissue and Cells and Clinical Trials Directives. The HFEA is a non-departmental government body that regulates and inspects all clinics providing in vitro fertilisation, donor insemination or the storage of eggs, sperm or embryos. Licences are only granted to those practitioners who exceed the HFEA’s stringent scientific and ethical standards and research on embryonic cells over 14 days old is forbidden.  

It is perhaps worth clarifying at this point that stem cells also exist in adult and young adult tissues. When raised as a topic it is often assumed that stem cells are necessarily embryonic.  Indeed, all of the research projects currently being assessed for funding by the Foundation begin their investigations with adult stem cells. For example, one of the projects examines the use of stem cells taken from a patient’s own bone marrow to heal damaged heart muscle. This technique has been supported by previous studies which demonstrate that the amount of damage to heart muscle in heart attack patients can be significantly reduced if stem cells taken from their own bone marrow are injected directly back into the heart. Another explores the use of adult stem cells located in the nasal lining to treat those with spinal cord injuries.  

Adult and embryonic stem cells differ in important ways including their ability to reproduce under laboratory conditions, to differentiate into different cell types, to survive and function after transplant and to avoid immune rejection. Scientists are currently working to determine the extent to which these different cells types will be useful in treating human ailments. It is thought that in the short term we will witness greater successes from adult stem cells, which are more easily manipulated in the laboratory. However, it is critical that we continue to explore both adult and embryonic research avenues to exploit their respective properties and to facilitate cross disciplinary generation of ideas.  

If Scotland is to support the growth of a stem cell industry then it must overcome a significant hurdle - the attraction of private investment. Many investors are concerned about the high risk profiles associated with stem cell based business models, the significant start up costs and the inevitably long lead times before commercially viable products will be ready for market. It is essential that the Government encourages risk-averse pharmaceuticals companies and venture capitalists to consider the prospects presented by stem cell technology both in the short and long term.  

The best ways to do this is to show public commitment and this is exactly what the Scottish Executive has done. The government has been working to support scientific Centres of Excellence, to facilitate trans-national partnerships and to provide an infrastructure for the commercial development of stem cells.  

Last November, Scottish Enterprise Edinburgh and Lothian announced continued funding for the Scottish Stem Cell Network pledging £1.85 million over the next ten years to promote interdisciplinary collaboration among scientists, researchers and clinicians working the field of stem cells.  

Construction work is scheduled to begin this summer on a new £35 million centre for stem cell research at Edinburgh University. The Centre for Regenerative Medicine, to be built at the Edinburgh Royal Infirmary, will include the most advanced technologies available in stem cell research, development and manufacture.  

In addition, a £5 million investment fund has been established specifically for translational stem cell research. This scheme is designed to encourage private investment in the sector by offering ‘matched’ public funding for each private pound provided.  

Ultimately however the success of these initiatives will be determined by the educational climate in which they are set. For Scotland to truly cement its position at the forefront of an emerging stem cell industry it must continue to engage not only academics, investors and industry players but also the community at large. It must foster dialogue and debate at every opportunity and it must communicate the very real benefits and prospects currently being derived from stem cells and to be realised in the future.

Sir Richard Sykes, Chairman of the UK Stem Cell Foundation

The UK Stem Cell Foundation, 20 Park Crescent, London W1B 1AL, Telephone: +44 (0) 20 7670 5370, info@ukscf.org