Shares in UK group ReNeuron were on the rise this week after regulators gave the final all clear for a landmark trial designed to test its stem cell therapy ReN001 as a treatment for stroke.

Investors welcomed news that the UK Gene Therapy Advisory Committee (GTAC) has issued a final approval for a ground-breaking, first-in-man clinical assessment of the therapy - the world’s first trial using expanded neural stem cells in this indication - which means that the group can move forward with its plans to kick-start the study sometime in April.

According to ReNeuron, ReN001 has shown promise in preclinical models of stroke by reversing the resultant damage to brain tissue responsible for disability when administered several weeks after the stroke itself, and consequently the group received funding from the Technology Strategy Board late last year to help it start its Phase I programme.

The trial, in which 12 patients who have been left disabled by an ischaemic stroke will be given ReN001 between six and 24 months following the event, will primarily focus on assessing the safety of the therapy, but the firm says it will also evaluate a number of efficiency measures over the course of the study.

If ReN001’s safety profile appears favourable, then ReNeuron said it intends to go down the accelerated clinical development pathway with an initial focus on patients severely disabled by stroke.

“In many ways, ReNeuron has set the regulatory pathway in the UK for cell therapy trials of this type, and we are delighted to have been given the opportunity to move ReN001 into its clinical phase on home territory in the UK,” Michael Hunt, chief executive of ReNeuron, previously commented.

There is a huge unmet clinical need for new treatments as current therapies, which focus on dissolving the clot to free blood flow to the brain, are only effective if administered within a very small timeframe following the stroke.

Only a very small proportion of patients make it to hospital in time to be eligible for treatment, and currently around 50% of people surviving strokes are left permanently disabled in one form of another, leading to associated health and social care costs of more than £5 billion a year in the UK.