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.

In June 2012, interim data from the PISCES study from the first five patients treated at that time was presented by the Glasgow clinical team at the 10th Annual Meeting of the International Society for Stem Cell Research (ISSCR) in Yokohama, Japan.  Reductions in neurological impairment and spasticity were observed in all five patients treated at that time compared with their stable pre-treatment baseline performance and these improvements were sustained in longer term follow-up. We expect that all remaining patients in the PISCES clinical trial will be treated by early 2013. 

We draw considerable encouragement from the progress of the PISCES study thus far and have now submitted an application to the UK regulatory authority to commence a multi-site Phase II clinical trial to examine the efficacy of our ReN001 stem cell therapy in patients disabled by ischaemic stroke. The trial is designed to recruit from a well-defined population of patients between two and four months after their stroke, which we and our collaborators believe will be the optimum treatment window for our therapy. On this basis, and subject to regulatory and ethical approvals, we hope to be able to commence the proposed Phase II stroke study in 2013.