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World's first stem cell trial for stroke patients passes safety test

05 September 2011

By Alison Cranage

Appeared in BioNews 623

A pioneering clinical trial to inject stem cells into the brains of disabled stroke patients has been cleared to progress to the next stage after no safety concerns were raised in the first three patients.

The PISCES (Pilot Investigation of Stem Cells in Stroke) study involving UK biotech company ReNeuron's 'ReN001' therapy is the world's first regulated clinical trial of a neural stem cell therapy for stroke, the company says. The therapy aims to repair damaged brain tissue and help restore mental and physical function in patients who have been disabled by stroke.

The study, being conducted at Glasgow's Southern General Hospital, has been cleared to advance to the next stage of evaluation. This will see nine patients receiving increasingly higher doses of ReN001, again to primarily assess safety.

Professor Keith Muir of Glasgow University, who is the principal investigator for the trial, said: 'We are pleased that there have been no safety issues from the first dose cohort in the PISCES trial and we look forward to evaluating further patients at a higher dose.

'ReN001 has the potential to address a very significant unmet medical need in disabled stroke patients and I am pleased that our team is involved in this pioneering clinical trial'.

Stroke is the third most common cause of death in England and Wales, according to the charity the Stroke Association.

The therapy uses stem cells originally derived from human fetuses. The development of stem cell treatments is still at an early stage and it is likely to be many years before these treatments are widely available.

Michael Hunt, chief executive of ReNeuron, told the BBC: 'The earliest a treatment could be widely available if everything goes very well is five years. It is very much a case of so far, so good. It is still at a very early stage but we draw great comfort from these results'.

Mirror | 02 September 2011
Injecting stem cells into patients' brains is safe, find scientists
Scotsman | 02 September 2011
Reuters | 09/2011
BBC | 09/2011


18 August 2014 - by Dr Barbara Kramarz 
Five stroke patients have begun to recover after being treated with their own stem cells, and have reported no side effects six months after treatment...
29 July 2013 - by Lanay Tierney 
UK biotech company ReNeuron is to relocate to Wales after securing £7.8m in grants and £5m equity investment from the Welsh government...
18 June 2012 - by Antony Blackburn-Starza 
Stroke patients involved in an early stage clinical trial of a stem cell treatment in Scotland have shown signs of slight improvement....
12 December 2011 - by Julianna Photopoulos 
A new Technology and Innovation Centre in Cell Therapy will open in London and receive funding of up to £50 million, the Technology Strategy Board announced. The new cell therapy centre, due to open in April 2012, is part of a £220 million programme to boost technology and manufacturing in the UK...

23 May 2011 - by Antony Blackburn-Starza 
A controversial stem cell therapy center operating out of Dusseldorf and Cologne, Germany, has closed. The news follows an undercover investigation by the Sunday Telegraph which claimed that the clinic offered unproven and dangerous stem cell therapies....
21 March 2011 - by Victoria Kay 
US scientists have identified a gene that may increase the risk of an early onset of stroke. They analysed the genomes of 14 Amish individuals affected by stroke and found a mutation in the SAMHD1 gene that was associated with the brain condition....
29 November 2010 - by Dr Rachael Panizzo 
A British man has become the first patient in the world to receive a pioneering stem cell therapy to repair brain damage caused by stroke....
10 May 2010 - by Dr Marianne Kennedy 
Certain variations of mitochondrial DNA are protective against strokes, according to a recent study in The Lancet Neurology....

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