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September 2, 2011

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Stem cell trial for stroke to go ahead

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

ReNeuron Group, the UK biotech firm behind the trial, yesterday said the independent Data Safety Monitoring Board had reviewed data from its ReN001 stem cell therapy and recommended the trial advance to the higher dose.

The company said: "Data from the laboratory safety tests, neurological examinations and neurofunctional tests conducted thus far indicate that the ReN001 treatment is safe and well tolerated at the initial dose."

The procedure involves injecting ReNeuron's neural stem cells into patients' brains in the hope they will repair areas damaged by stroke, thereby improving both mental and physical function.

It uses stem cells derived from human fetuses rather than those from embryos, which were used in a stem cell trial to treat patients with spinal cord injuries by Geron Corp of the US. An embryo develops into a fetus after a few weeks development.

ReNeuron's chief executive -Michael Hunt said the clearance was an important milestone, and the preliminary data also supported the group's other therapeutic programs using the neural stem cell line on which the stroke treatment is based.

The principal investigator for the trial, Keith Muir from the University of Glasgow's Institute of Neuroscience and Psychology, said he looked forward to evaluating further patients on a higher dose.

He added: "ReN001 has the potential to address a very significant unmet medical need in disabled stroke patients and I am pleased our team is involved."

Shares in ReNeuron rose 3.3 percent on the news.

Analysts at Matrix said ReNeuron could set the company apart from other stem-cell companies in the field, given the other advantages it has in terms of manufacturing, scalability and the off-the-shelf nature of the technology.

They said: "The data generated thus far are all the more remarkable, in our view, given the fact that the patients receiving the cells have not been subject to immunosuppression. We look forward to the data from the next cohort within this study."



 

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