This approval represents the final national regulatory step in taking the ReN001 therapy into patients in the UK, following regulatory approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) last year.
The company is now working with its chosen contract research organisation (CRO) to finalise local arrangements for the clinical trial at the trial site, as well as completing various other contractual, registration and documentation requirements. After this, patient recruitment and evaluation for the trial will begin, most likely in April of this year.
In this ground-breaking phase I trial, the world’s first using expanded neural stem cells in this indication, ReNeuron’s ReN001 stem cell therapy, will be administered to stroke patients who have been left disabled by an ischaemic stroke.
The ReN001 clinical trial will take place through the NHS at the Institute of Neurological Sciences, Southern General Hospital, Greater Glasgow and Clyde NHS Board.
The trial is designed primarily to test the safety profile of ReN001 in ischaemic stroke patients at a range of cell doses, but a number of efficacy measures will also be evaluated over the course of the trial. Patients in the trial will be monitored for two years, with longer term follow-up procedures in place thereafter. Subject to satisfactory safety data arising from the early patient cohorts in the trial, the company intends to pursue an accelerated clinical development pathway with ReN001, focusing initially on more severely disabled stroke patients.
Michael Hunt, chief executive officer of ReNeuron, said: “This final approval represents the culmination of many months of work in taking our ReN001 therapy through the regulatory pathway in the UK, a process untested by other stem cell therapy approaches of this type. We are therefore pleased to have in many ways pioneered this pathway for subsequent cell therapy applications, including, of course, those of ReNeuron’s other cell therapy candidates currently in development. We are also very pleased to be undertaking this ground-breaking clinical trial at a leading NHS hospital and we look forward to reporting on progress with the trial as it finally gets underway this year.”