Researchers find encouraging data in neural stem cell therapy

Medical researchers have found encouraging data in neural stem cell therapy for disabled stroke patients and are hopeful for a successful phase-II trials of the experiment later this year.
The updated interim data was presented by the researchers from the trial of PISCES (Pilot Investigation of Stem Cells in Stroke) study to the 22nd European Stroke Conference here today.
The trial has seen the brains of ischaemic stroke patients (Patients with neurological disorders after reduced blood supply) injected with neural stem cells to test the safety and tolerability of the treatment.
Professor Keith Muir of the University of Glasgow, who is heading the trial of ReNeuron Group plc's ReN001 stem cell therapy at the Southern General Hospital, Glasgow, said the data from the first nine patients treated has shown no cell-related or immunological adverse affects.

Muir added that most patients had experienced sustained modest reductions in neurological impairment compared to their pre-treatment baseline performance, accompanied by improvement in abilities to undertake day to day tasks.
A further two patients have been treated since the data were collated and the trial is now drawing to a close, with full results due to be published next year.

Meanwhile, plans are proceeding for a Phase II trial which will examine the efficacy of stem cell treatment in stroke patients and an application is expected to be submitted to the UK regulatory authorities in early July.
If approved, the Phase II trial is scheduled to commence later this year, he said.

The Phase II trial will be a controlled multi-centre trial involving around 20 patients initially, all of whom will have suffered a stroke within a few weeks.
"We remain pleased and encouraged by the data emerging from the PISCES study," said Muir.
The data to date identify no safety issues with the ReN001 treatment - which is the primary focus of this Phase I trial, he said.
"The evidence of functional improvement requires further investigation in a suitably designed Phase II efficacy study and we look forward to being a principal clinical site in that study when it commences," Michael Hunt, Chief Executive Officer of ReNeuron, said.

The PISCES study is the world's first fully-regulated clinical trial of a neural stem cell therapy for disabled stroke patients.
Stroke is the third largest cause of death and the single largest cause of adult disability in the developed world.
The trial is being conducted at the Institute of Neurological Sciences, Southern General Hospital, Greater Glasgow and Clyde NHS Board.