Stroke patients show signs of recovery in stem-cell treatment trial
May 29, 2013
Encouraging interim data from the world’s first clinical trial examining the safety of neural stem cell treatment in ischemic stroke patients has been reported by researchers ahead of an application for Phase II trials.
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 reported 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, data from the first nine patients treated has shown. No cell-related or immunological adverse affects were found, he said.
Updated interim data from the PISCES trial, which has seen the brains of ischemic stroke patients injected with neural stem cells to test the safety and patient ability to tolerate the treatment, was presented to the 22nd European Stroke Conference in London on Tuesday 28 May.
Two more 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.
Phase II trial
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.
The Phase II trial will be a controlled multi-center trial involving around 20 patients initially, all of whom will have suffered a stroke within a few weeks.
The data to date identify no safety issues with the ReN001 treatment — which is the primary focus of this Phase I trial — Muir reported.
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.