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 PISCES clinical 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 safety study, ReNeuron’s ReN001 stem cell therapy is being administered in ascending doses to a total of 12 stroke patients who have been left disabled by an ischaemic stroke, the most common form of the condition.  The Principal Investigator for the trial is Professor Keith Muir, SINAPSE Professor of Clinical Imaging, Division of Clinical Neurosciences at the University of Glasgow. The aim of the clinical trial is to evaluate the safety of the implantation technique and to establish the side effect profile associated with the implantation of ReN001 stem cells in patients who have suffered an ischaemic stroke.

Patients in the PISCES trial will be followed up over a two year period. Ongoing monitoring of the patients will also continue in the longer term following the two year end-point. Although the primary endpoints of the clinical trial relate to the safety and tolerability of the ReN001 treatment, a number of clinical assessments of the patients in the trial will be made to evaluate changes in both motor and cognitive function over time.  We hope to use these potential efficacy measures in the design of subsequent clinical studies where efficacy of the treatment would be the primary endpoint.

No cell-related adverse events have been reported in any of the patients treated to date and neurological and other safety assessments reviewed by the independent Data Safety Monitoring Board show no deterioration in the health of any of the patients as a result of the ReN001 treatment.

We expect that all remaining patients in the PISCES clinical trial will be treated over the course of 2012.  We draw considerable encouragement from the progress of the PISCES study thus far and we have commenced the planning and design of a Phase II efficacy study with ReN001. In particular, we hope to be able to set criteria for this efficacy study that will target patients who we believe will best respond to the treatment in terms of the type, size and location of the stroke infarct which has caused their disability.  During 2012, we intend to seek advice and clarification from the UK and other regulatory authorities regarding our clinical development strategy for ReN001, with a view to commencing a Phase II study in 2013.