January 19, 2009
Stem Cell Trial Set To Begin
Patients left disabled by stroke may receive help through the outcome of a pioneering clinical trial to assess if stem cell therapy can make a difference in the condition.
British biotechnology company, 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 fetal stem cells.The company is hailing the announcement as a victory, since it has failed to win approval for similar tests from U.S. regulators.
"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.
Later this year, researchers will recruit the first patients for the Phase I program at the Institute of Neurological Sciences, Southern General Hospital, Glasgow.
Twelve patients will receive ReNeuron's ReN001 cell therapy between six and 24 months after their stroke.
Researchers believe the new cells, which come from a cell line originally taken from aborted fetal tissue, will regenerate parts of the brain damaged by stroke.
The procedure involves the direct injection of millions of cells into the affected brain region. The initial tests examine the safety and feasibility of the treatment, with larger studies planned later if the first phase is successful.
Chief Executive Michael Hunt said the clinical trial was the most important milestone in the company's history.
Image Caption: This image depicts a colony of human embryonic stem cells grown over a period of 10 months in the absence of mouse feeder cells. The cell nuclei are stained green; the cell surface appears in red. Photo: courtesy Ren-He Xu, University of Wisconsin - Madison
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