ReNeuron receives final regulatory approval to commence landmark stroke clinical trial in UK

The UK's ReNeuron Group says that the UK Gene Therapy Advisory Committee (GTAC) has given a full and final Favorable Opinion for the firm's proposed first-in-man clinical trial with its ReN001 stem cell therapy for stroke. The GTAC acts as the national research ethics committee for gene therapy and stem cell therapy clinical trials in the UK.

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 organization to finalize local arrangements for the clinical study at the trial site as well as completing various other contractual, registration and documentation requirements, after which 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 ischemic stroke, the most common form of the condition. Stroke is the third largest cause of death and the single largest cause of adult disability in the developed world.