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Stem cell trial for stroke is safe

Published on 01/09/11 at 10:33am

A pioneering stem cell treatment for patients who have suffered a stroke has been ruled safe, and can continue to higher doses.

UK company ReNeuron ultimately hopes the treatment can help reverse much of the damage caused by stroke.

The PISCES trial being conducted in Glasgow aims to treat 12 patients who have been left disabled by stroke. But the first goal is to prove the technique causes no harm, and data from the first three patients to receive treatment show no problems so far.

An independent Data Safety Monitoring Board (DSMB) recommended that the trial moves ahead to a higher dose of its stem cell treatment ReN001 after reviewing data from the three patients, who have received a low dose of the stem cells.

The data collected was based on the first patient being assessed at nine months after treatment, the second patient at six months and the third patient at three months.

The principal investigator for the trial is Professor Keith Muir, at the Centre for Stroke Research at the University of Glasgow. 

He 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.”

Michael Hunt, chief executive of ReNeuron, added: “This represents an important milestone for the trial and the preliminary data from the trial also add value to our other therapeutic programmes using the CTX neural stem cell line that forms the basis of the ReN001 stroke treatment.”

The next dose cohort of three further patients are expected to be treated by the end of this year, with the remaining patients all treated in 2012. ReNeuron says it then aims to have discussed and agreed the next steps for ReN001 with the UK and worldwide regulators.

The PISCES study (Pilot Investigation of Stem Cells in Stroke) 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 in Scotland at the Institute of Neurological Sciences, Southern General Hospital, Greater Glasgow and Clyde NHS Board. 

In this phase I single administration dose escalation study, the ReN001 stem cell therapy is being given to 12 stroke patients who have been left disabled by an ischaemic stroke, the most common form of the condition. The study will test its safety and tolerability in progressive doses while evaluating efficacy measures for the design of future clinical trials with ReN001, including structural and functional MRI imaging measures as well as a number of tests of sensory, motor and cognitive functions. 

Patients in the clinical trial will be monitored for two years, with longer term follow-up procedures in place thereafter. 

Professor Muir will present further data regarding progress with the PISCES trial at the Stroke Association’s UK Stroke Forum Conference in Glasgow from 29 November to 1 December 2011.

Andrew McConaghie

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