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UK approves stem cell trials
Source: Agencies |
January 20, 2009, Tuesday
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A BRITISH biotechnology company, working with a team of doctors in Glasgow, is to launch a pioneering clinical trial to assess whether stem cell therapy can help patients left disabled by stroke.
The ReNeuron Group said it had received approval from the UK Medicines and Healthcare Products Regulatory Agency to commence the trial using foetal stem cells.
The move is a victory for the company, which has so far failed to win approval for similar tests from regulators in the United States. 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 at the Southern General Hospital in the second quarter of this year.
A total of 12 patients will receive ReNeuron's ReN001 cell therapy between 6 and 24 months after their stroke.
The hope is that the new cells, which are derived from a cell line originally taken from aborted foetal tissue, will regenerate parts of the brain damaged by stroke.
The potential of different kinds of stem cells - master cells that can develop into specialised 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 region.
The initial tests will look primarily at the safety and feasibility of the treatment, with larger studies planned if they are successful.
"Stem cell treatment offers the potential to repair brain tissue lost as a result of stroke," Keith Muir, a senior lecturer in neurology at Glasgow University, said.
The ReNeuron Group said it had received approval from the UK Medicines and Healthcare Products Regulatory Agency to commence the trial using foetal stem cells.
The move is a victory for the company, which has so far failed to win approval for similar tests from regulators in the United States. 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 at the Southern General Hospital in the second quarter of this year.
A total of 12 patients will receive ReNeuron's ReN001 cell therapy between 6 and 24 months after their stroke.
The hope is that the new cells, which are derived from a cell line originally taken from aborted foetal tissue, will regenerate parts of the brain damaged by stroke.
The potential of different kinds of stem cells - master cells that can develop into specialised 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 region.
The initial tests will look primarily at the safety and feasibility of the treatment, with larger studies planned if they are successful.
"Stem cell treatment offers the potential to repair brain tissue lost as a result of stroke," Keith Muir, a senior lecturer in neurology at Glasgow University, said.
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