ReNeuron’s ground-breaking stem cell trial approved
pharmafile | January 22, 2009 | News story | Research and Development |Â Â ReNeuron, stem cellÂ
UK biotech ReNeuron has been given the go-ahead for a ground-breaking stem cell clinical trial.
The phase I trial of its stroke therapy will be the first of its kind and boosts the UK’s position in the stem cell research.
ReN001 consists of a neural stem cell line and is injected directly into the brain, removing the need for immunosuppression and the risks associated with it.
ReNeuron’s chief executive Michael Hunt said the trials approval was a significant development in translating stem cell science into clinical-stage therapies.
“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,” he added.
It is a different picture in the US, where ReNeuron has so far failed to win approval for its ReN001 trial from the FDA, which has placed a clinical hold on the application.
Approximately 150,000 people suffer a stroke in the UK each year and approximately half of all survivors are left with permanent disabilities.
The UK first-in-man trial will involve 12 patients left disabled by an ischaemic stroke, the most common form of the condition.
The only available treatment is to give anti-clotting agents to dissolve the clot causing the blockage in blood flow to the brain. But this has to be given within several hours of a stroke and only a small proportion of patients get to hospital in time for this.
If ReN001 is proved safe and clinically effective it would offer a significant new treatment option for stroke survivors and the potential for a degree of recovery of function in those left disabled.
ReNeuron expects to start recruiting patients in the second quarter of this year for the trial.
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