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

5 September 2011
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'.

Brain stem cell trial passes safety test
Mirror |  2 September 2011
Injecting stem cells into patients' brains is safe, find scientists
Scotsman |  2 September 2011
Pioneering UK stem cell trial passes safety test
Reuters |  09/11
UK stem cell stroke trial passes first safety test
BBC |  09/11
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