PISCES Clinical trial in stroke patients
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
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 May 2013, interim data from the first nine patients treated in the PISCES study was presented by the clinical team from Glasgow’s Southern General Hospital at the 22nd European Stroke Conference in London.
• National Institutes of Health Stroke Scale (neurological deficit): improved by median 1 point at 1 month post-treatment (n=9) and 3 points at 1 year (n=5)
• Barthel Index (functional outcome): improved by median 1 point at 3 months (n=8) and 4 points at 1 year (n=5)
• Modified Rankin Score (disability and handicap): improved by median 1 grade at 1 year (n= 5)
• Summated Ashworth scores for affected limbs (spasticity): improved by mean 4.5 at 3 months (n=9) and 7.2 at 1 year (n=5).
Since the above data were collated, the remaining patients in the PISCES study have been treated, with no subsequent cell-related or immunological adverse events reported.
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.