Despite great hopes for stem cell therapy, major structural and cultural changes within the NHS are needed if it is to succeed in the UK. Currently the chances of getting effective treatments into routine use in the short-term are small and the industry is at serious risk of 'market failure'.
These are the findings of two major studies into the commercialisation and adoption of stem cell therapy carried out by researchers at The University of Nottingham.
Dr Paul Martin, from the Institute of Science and Society said: "While the government has identified regenerative medicine as a national priority and the US has lifted its ban on stem cell therapy, urgent public policy action is needed if it is to become a reality. Although cell therapy is now established as an important branch of medicine, innovative firms struggle to make money, putting the UK industry in a very vulnerable position in the short term. Unless the situation changes the industry will contract and the progress needed to develop important cell therapies will be adversely affected."
The research, funded by the Engineering and Physical Sciences Research Council (EPSRC) identified a number of important barriers to knowledge translation. It found that closer collaboration with clinicians was needed along with better funding for clinical studies, greater regulatory certainty and clearer reimbursement policies. There is also a need to develop enabling technologies to lower manufacturing costs.
Commercial activity in cell therapy has grown very significantly since 2002. The industry now involves nearly 200 companies developing primary and secondary cell therapies, plus another 180 banking cord blood. In total the global cell therapy industry currently has sales of over $1 billion a year and a steady number of products are now reaching late stage clinical trials. However, the sector suffers from a high level of company turn over. As a consequence, the industry is dominated by small, young companies lacking the resources to bring products easily and successfully to market and those that do struggle to make sales.
Dr Martin, whose expertise lies in the sociology of emerging medical technologies, said: "There are major structural barriers within the NHS that make it difficult to translate new scientific knowledge of stem cells into improved patient care. For a clinician to use a cell therapy routinely it needs to meet a number of strict criteria. They are also expensive and many are yet to have proven clinical outcomes."
The reports are the result of a two-year study examining the UK regenerative medicine sector. They have been published ahead of the second National Stem Cell Network's Annual Scientific Conference which is being held at Oxford University on Monday 6 April 2009 to Wednesday 8 April 2009. The conference attended by leading experts in the field is a celebration of the latest in UK stem cell science.