ReNeuron to begin landmark stem cell trial for stroke
pharmafile | February 19, 2010 | News story | Research and Development | ReNeuron, stem cell
ReNeuron has been given the go-ahead to begin clinical trials of the first ever stem cell therapy for patients disabled by stroke.
The UK company has gained final approval from the Gene Therapy Advisory Committee (GTAC) to conduct the a trial of its therapy ReN001, the first of its kind anywhere in the world.
Pre-clinical studies of ReN001 in rats have shown the therapy helped to reverse some stroke disability, even though it was administered several weeks after a stroke occuring.
Stroke is the third biggest killer in the UK after heart disease and cancer. Of the 150,000 Britons who suffer a stroke every year, more than a third die from the condition and around half of all survivors are left with permanent disabilities. Beyond the acute phase, there are no currently no treatments other than rehabilitation measures which can help restore mobility and use of affected arms and legs.
Now the therapy is to be tested in human for the first time. Beginning in April, 12 patients who have suffered an ischaemic stroke in the UK are to receive the neural stem cells, which promise to reverse the disabling effect of stroke. Patients who have suffered a stroke between six and 24 months earlier will be eligible for the phase I trial, which will evaluate the safety of the surgical technique of implanting the stem cells, as well as establishing ReN001’s side effect profile.
The study will also collect preliminary efficacy data by evaluating any improvement reported in stroke-specific assessments of neurological function that will be carried out during the study.
The burden of stroke
The potential for the treatment to help disabled stroke patients is clear, and could allow greater independence and quality of life for patients if proven to be safe and effective. The annual health and social costs of caring for disabled stroke patients is huge – estimated to be more than £5 billion in the UK, with stroke patients occupying 25% of long term hospital beds.
The phase I trial is to be conducted in the NHS in Greater Glasgow. Patients participating will be monitored for two years with longer term follow-up procedures in place thereafter.
ReNeuron received a government-supported grant in September last year to develop ReN001, and the UK company was given the go ahead to recruit patients in the same second quarter of 2009 by the UK regulator the MHRA. ReNeuron’s chief executive Michael Hunt 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.”
He added that the company was pleased to have pioneered the regulatory pathway, which he said would pave the way for other treatments, including further ReNeuron’s cell therapy candidates in development.
“We are also very pleased to be undertaking this groundbreaking clinical trial at a leading NHS hospital and we look forward to reporting progress with the trial as it finally gets underway this year.”
Related Content
Stem cell therapy offers hope for spinal cord injuries
Scientists have brought the prospect of spinal cord injuries being able to be treated with …
Gene therapy helps child regrow 80% of skin
A young child has been brought back from the verge of death after an experimental …
ReNeuron’s stem cell therapy improves motor function in stroke study
ReNeuron, a UK-based biotechnology company, posted results of its experimental stem cell therapy for patients …
