BioWorld Today Correspondent

LONDON - Stem cell innovation in the UK is at risk because of structural and cultural barriers that stand in the way of translating products into clinical use.

The chances of getting effective treatments into routine use in the near term are small, and the industry is at serious risk of market failure, according to two studies published Monday as the stem cell community gathered for its annual conference in Oxford, UK.

Paul Martin, of Nottingham University, who did the research, said that while the government has identified regenerative medicine as a national priority, 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."

Martin added that unless the situation changes the industry will contract. "The progress needed to develop important cell therapies will be adversely affected," he wrote.

There are already plenty of signals. Despite the government's commitment to creating the most liberal regime for stem cell research - which includes sanctioning attempts to produce hybrid embryos from enucleated animal eggs fused with adult human cells - the UK's commercial sector is in a feeble state.

Last week, the oldest company, Stem Cell Sciences plc, confirmed it had been acquired in a fire sale forced on it by an inability to raise funds, while another specialist, Sheffield University spinout Axordia Therapeutics Ltd., was acquired recently by Intercytex plc, which is now up for sale.

Fetal stem cell specialist ReNeuron plc almost was undermined by regulatory delay in approving a clinical trial of ReN001, a treatment for stroke.

Two years after applying for permission from the FDA, the company managed to persuade UK regulators to allow a trial. That persuaded investors to put in more funds to enable it to take place.

If that does not sound hard enough, many of the barriers identified by Martin are ones that UK companies have yet to tackle. He found that closer collaboration with clinicians is needed, along with better funding for clinical studies, greater regulatory certainty and clearer reimbursement policies.

There also is a need to develop enabling technologies to lower manufacturing costs.

According to the research, global commercial activity in cell therapy has grown significantly since 2002. The industry now involves nearly 200 companies developing primary and secondary cell therapies, plus another 180 banking cord blood. The global cell therapy industry currently has sales of more than $1 billion a year.

However, the sector suffers from a high level of company turnover. As a consequence, it is dominated by small, young companies lacking the resources to bring products to market.

Martin, whose expertise lies in the sociology of emerging medical technologies, said there are other hurdles that are specific to the UK.

"There are major structural barriers within the National Health Service that make it difficult to translate new scientific knowledge of stem cells into improved patient care," he wrote.

Away from the perils of commercialization, the National Stem Cell Network's Annual Scientific Conference held at Oxford University this week heard of advances, including the work of Marcelo Rivolta at Sheffield University, who has succeeded in inducing mouse stem cells to generate the sensory hair cells and neurons that are essential for hearing. In humans, loss of these cells is a major cause of deafness, as the body cannot grow replacements.

Rivolta said he believes his research eventually could translate into a stem cell therapy for deafness.

The next stage is to study how those cells integrate and grow in animal models.