Based on a review of the safety data from a first dose cohort of three patients treated with ReN001—a stem cell therapy for disabled stroke patients—, ReNeuron announced on 1 September that the independent Data Safety Monitoring Board (DSMB) for its clinical trial had recommended advancement of the study to the evaluation of a higher dose of ReN001. ReNeuron reported that the first patient in this next dose cohort of three patients has been successfully treated and discharged from hospital with no acute safety issues arising.
As previously reported, the company expects that the remainder of this next dose cohort will be treated by the end of this year. The remaining dose cohorts in the PISCES trial (Pilot investigation of stem cells in stroke) are expected to be treated over the course of 2012, at which point ReNeuron intends to have discussed and agreed its subsequent clinical development strategy for ReN001 with the relevant regulatory authorities both in the UK and beyond.
The PISCES study is the world’s first fully regulated clinical trial of a neural stem cell therapy for disabled stroke patients. 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 administered to a total of 12 stroke patients who have been left disabled by an ischaemic stroke, the most common form of the condition. The aim of the study is to test the safety and tolerability of the treatment 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 Keith Muir, SINAPSE professor of Clinical Imaging, Centre for Stroke Research, Institute of Neuroscience and Psychology at the University of Glasgow, Scotland, is leading the study. In an interview with BBC news he commented, “We need to be assured of safety before we can progress to trying to test the effects of this therapy. Because this is the first time this type of cell therapy has been used in humans, it is vitally important that we determine that it is safe to proceed, so at the present time we have the clearance to proceed to the next higher dose of cells.”