In a very small trial that may suggest the possibility of significant future results, the PISCES study conducted at the University of Glasgow with scaled fetal neural cells produced by ReNeuron Group is the world’s first fully regulated clinical trial of a neural stem cell therapy for disabled stroke patients. In this open label, dose-ranging Phase I 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. ReNeuron is located in the UK and is traded on the London AIM market under the symbol RENE.L.
To date, six patients have been treated in the PISCES stroke study, representing the first two of four dose cohorts. The interim data being presented are from the first five patients treated, at 2 x 12 month, 1 x six month and 2 x three month follow-up points.
Reductions in neurological impairment and spasticity were observed in all five patients compared with their
Neurological deficits were measured using the National Institutes of Health Stroke Scale (NIHSS), a higher score representing a worse deficit. Patients are required to have a NIHSS score of at least 6 to participate in the study. The pre-treatment median score for the first five patients was 8 (range 6 to 10) and the three month post-treatment median score was 4 (range 3 to 9).
Spasticity was measured using the Summated Ashworth Scale for affected upper and lower limbs, a higher score representing a higher degree of spasticity. The pre-treatment mean score for the first five patients was 28.6 (range 12 to 55) and the three month post-treatment mean score was 21.8 (range 5 to 42).
Functional magnetic resonance imaging (fMRI) data were also collected pre- and post-treatment to identify potential biomarkers of change in neurological function in the brains of the treated patients. Some longitudinal changes in motor activation fMRI were seen, consistent with the observed improvements in neurological measures.
"The data indicate that the ReN001 treatment has a good safety profile at the doses administered thus far," said Professor Keith Muir, SINAPSE Professor of Clinical Imaging, Division of Clinical Neurosciences at the University of Glasgow and principle investigator. "The preliminary signals of potential functional benefit, whilst intriguing, will require further investigation in a suitably designed Phase II efficacy study. The clinical team looks forward to dosing patients in the remaining higher dose cohorts in the PISCES study over the coming months.”
ReNeuron says the following about their stem cell technology:
"We have used our cell expansion and screening technologies to develop “off-the-shelf” stem cell therapies for serious conditions such as stroke where the patient populations are significant and where few if any alternative treatments exist. Unlike conventional drug treatments which typically address the symptoms of disease, the potential of stem cell treatments such as ours is to address the underlying causes of the target disease. Our stem cell treatments have been shown in pre-clinical testing to stimulate natural repair mechanisms in the organs affected by the disease in question, leading to a reduction in the functional impairments associated with the disease."
Adapted from the ReNeuron Group announcement.