LONDON – A British biotechnology company, working with a team of doctors in Scotland, is to launch a pioneering clinical trial to assess whether stem cell therapy can help patients left disabled by stroke.
ReNeuron Group Plc said on Sunday it had received approval from the UK Medicines and Healthcare Products Regulatory Agency to commence the clinical trial using its fetal stem cells.
The move is a victory for the company, which has so far failed to win approval for similar tests from U.S. regulators. It also represents a boost for Britain's position as a leader in developing stem cell treatments.
The first patients are expected to be recruited into the Phase I program at the Institute of Neurological Sciences, Southern General Hospital, Glasgow, in the second quarter of this year.
A total of 12 patients will receive ReNeuron's ReN001 cell therapy between six and 24 months after their stroke.
The hope is that the new cells, which are derived from a cell line originally taken from aborted fetal tissue, will regenerate parts of the brain damaged by stroke.
The potential of different kinds of stem cells — master cells that can develop into specialized tissue in the body — is being examined by experts around the world for many diseases.
ReNeuron's procedure involves the direct injection of millions of cells into the affected brain region. The initial tests will look primarily at the safety and feasibility of the treatment, with larger studies planned later if the first phase is successful.
"Stem cell treatment offers the potential to repair brain tissue lost as a result of stroke," principal investigator Keith Muir, a senior lecturer in neurology at the University of Glasgow, said in a statement.
"We are very excited at the opportunity to undertake this, the first clinical trial involving neural stem cell therapy in stroke." About half of all stroke survivors are left with permanent disabilities as a result of brain damage.
ReNeuron Chief Executive Michael Hunt said the clinical trial was the most important milestone in the company's history and the firm is due to announce the news to the London Stock Exchange on Monday morning.
ReNeuron became Europe's first stem cell company to float in 2000, but was taken private in 2003 after a series of clinical setbacks and the bursting of the technology bubble hammered its share price. It relisted in 2005.