The chances of getting effective stem cell treatments into routine use in the National Health Service (NHS) in the short term are currently small, and the industry is at serious risk of market failure, researchers warn.

Despite great hopes for stem cell therapy, major structural and cultural changes are necessary within the NHS if it to succeed in the UK, say two studies by researchers at The University of Nottingham into the commercialisation and adoption of stem cell therapy.

The studies reveal a number of significant barriers to knowledge translation at present. There is a need for closer collaboration with clinicians, better funding for clinical studies, greater regulatory certainty and clearer policies regarding reimbursement, say the study authors. Also, enabling technologies must be developed in order to lower manufacturing costs.

“There are major structural barriers within the NHS that make it difficult to translate new scientific knowledge of stem cells into improved patient care,” said Dr Paul Martin, of the University’s institute of Science and Society, who led the research. “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,” he added.

Commercial activity in cell therapy is grown very significantly since 2002. The industry now involves nearly 200 companies developing primary and secondary cell therapies, with another 180 banking cord blood. Sales for the global cell therapy industry are currently over $1 billion a year, and a steady number of products are now reaching late-stage clinical trials.

However, the sector is characterised by a high level of company turnover and is therefore dominated by small, young companies which lack the resources to bring products easily and successfully to market. Those that do so struggle to make sales, say the studies.

“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,” said Dr Martin. “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,” he warned.

- The research findings, which are the result of a two-year study examining the UK regenerative medicine sector funded by the Engineering and Physical Sciences Research Council (EPSRC), have been published ahead of the second National Stem Cell Network’s annual scientific conference, organised by the Biotechnology and Biological Sciences Research Council (BBSRC) and being held at Oxford University this week.