ReNeuron Group received the green light to complete the final stages of first phase safety testing of its ReN001 stem cell therapy for disabled stroke patients in Scotland, the company announced Tuesday.
The ReN001 stem cell therapy was 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 now set to proceed with dosing the last three patients after getting clearance from the Data Safety Monitoring Board which reviewed the study.
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The first of the three patients was treated with ReN001 and discharged from hospital. The remaining two are scheduled to be treated this March.
Last year, interim data from the first five patients treated in the study were presented by the Glasgow clinical team. Sustained reductions in neurological impairment and spasticity were observed in all patients compared with their stable pre-treatment baseline performance.
Further and longer term data from the study are expected to be presented in scientific conference later this year.
The company has submitted an application to the UK regulatory authority to commence a multi-site phase two clinical trial to examine the efficacy of ReN001 in patients disabled by an ischaemic stroke. Preparations are underway to begin the trial mid-year.
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