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World First In-Human Stem Cell Trial Begins in Glasgow

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The first patient has been treated with stem cell therapy in a ground-breaking UK clinical trial led by the University of Glasgow, it was announced today. 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. According to Professor Keith Muir, Principal Investigator for the trial, the patient underwent the successful surgical procedure at Glasgow’s Southern General Hospital and has now been discharged.  The patient will be monitored closely for two years, with longer term follow-up procedures in place

thereafter. Prof Muir, Sinapse Chair of Clinical Imaging, from the University’s Institute of Neuroscience and Psychology, said: “We are pleased that the first patient in the PISCES trial has undergone surgery successfully. “Stroke is a common and serious condition that leaves a large number of people with significant disability. In this trial we are seeking to establish the safety and feasibility of stem cell implantation, which will require careful follow-up of the patients who take part. “We hope that in future it will lead on to larger studies to determine the effects of stem cells on the disabilities that result from stroke.” The trial, being carried out with ReNeuron Group plc, uses expanded neural stem cells, which are the basis of Reneuron’s ReN001 stem cell therapy for stroke patients. The PISCES study will test the safety of ReN001 in ischaemic stroke patients at a range of cell doses, but a number of other measurements of its impact will also be evaluated over the course of the trial. The ReN001 cells were administered by direct injection into the affected region of the brain in a routine surgical procedure. The PISCES trial was given approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in January 2009. Ischaemic stroke is the most common form of the condition and is caused by a blockage of blood flow in the brain as opposed to a haemorrhagic or bleeding stroke. Stroke is the third largest cause of death and the single largest cause of adult disability in the developed

world. ReNeuron is the first company to have received regulatory approval for any stem cell-based clinical trial in the UK. The nature of the procedure and the characteristics of the ReN001 cells mean that the patients taking part in the trial will not need immunosuppression following treatment, thus eliminating the safety risks typically associated with immunosuppression regimens. Michael Hunt, Chief Executive Officer of ReNeuron, said: “The initiation of the PISCES clinical trial is a major and hard-won milestone for ReNeuron and a significant milestone in the development of therapies to address the severely disabling effects of ischaemic stroke. “We are delighted to be working with Professor Keith Muir and his team at one of Europe’s pre-eminent stroke treatment centres and, in so doing, helping to promote the uptake of clinical innovation in the NHS system.  Our thanks and best wishes go to the first patient and his family for their participation in this important and ground-breaking clinical trial. ”  –  Prof Keith Muir SINAPSE Chair of Clinical Imaging. Research interests; Major interests are in the treatment of acute stroke and the application of advanced brain imaging techniques to aid treatment decisions in acute stroke;

thrombolysis for stroke; clinical trials and clinical trial design in acute stroke; and the inherited syndrome CADASIL (Cerebral Autosomal Dominant Arteripathy with Subcortical Infarction and Leucoencephalopathy). Research work is predominantly undertaken in the South Glasgow Acute Stroke Service, based in the Institute of Neurological Sciences, where we have established a unit with the highest rates of IV thrombolytic treatment in the UK (and in the top 10 in Europe). Currently, we use a mixture of advanced imaging techniques including CT perfusion and CT angiography, MRI (including novel sequences being developed locally for metabolic imaging) and TCD. The specific techniques depend upon the individual research question – recent work has included the use of MR spectroscopy and DWI lesion volume evolution to investigate the therapeutic effects of insulin treatment for hyperglycaemia in acute stroke, and ongoing studies are investigating the influence of hyperglycaemia on recanalisation and reperfusion rates in acute stroke.The stroke imaging group includes clinical neuroradiologists, physicists, and neuroscientists, and there is close collaboration between preclinical imaging in rodent models of cerebral ischaemia with the clinical studies. 15 Nov 2010 Eleanor Cowie,  Media Relations. News from: University of Glasgow   gla.ac.uk

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