ReNeuron Group (LON:RENE) today reported that the first patient has been treated with its ReN001 stem cell therapy for stroke in the PISCES trial.
The patient has been safely discharged from the hospital two days after the straightforward neuro-surgical procedure used to administer the ReN001 cells.
The Pilot Investigation of Stem Cells in Stroke (PISCES) study is the world's first fully regulated clinical trial of a neural stem cell therapy for disabled stroke patients, while ReNeuron is the first company to have received regulatory approval for any stem cell-based clinical trial in the UK.
In this Phase I trial, ReNeuron's ReN001 stem cell therapy is being administered to stroke patients who have been left disabled by an ischaemic stroke, the most common form of the condition.
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.
Assuming a satisfactory review of the first patient's progress by independent Data Safety Monitoring Board in December, the remainder of the first dose cohort in the trial will be treated shortly thereafter.
If the safety data from the early patient cohorts is satisfactory, ReNeuron will pursue an accelerated clinical development pathway with ReN001, focusing on particular stroke patient groups who are expected to most benefit from the therapy.
ReNeuron called the initiation of the trial a significant milestone in the development of therapies to address the severely disabling effects of ischaemic stroke.
“In this trial, we are seeking to establish the safety and feasibility of stem cell implantation, which will require careful follow-up of the patients who take part.
“We hope that in future it will lead on to larger studies to determine the effects of stem cells on the disabilities that result from stroke,” said Keith Muir, the principal investigator for the trial.
Last month, ReNeuron’s peer Geron Corp (NASDAQ:GERN) launched the first American trial to treat spinal injury patients with stem cells, revealing the first patient ever to take part in such a test has begun the treatment.
Broker Daniel Stewart & Company (DS&C) called this a major milestone for the stem cell therapeutics sector, which serves as a positive read-across for ReNeuron.
ReNeuron’s ReN001 stem cell therapy offers the potential for a degree of recovery of function in disabled stroke patients, resulting in an improvement in quality of life and a reduced reliance on health and social care systems.
ReNeuron believes that ReN001 could radically alter the treatment of disabled stroke patients.
In February 2010, ReNeuron received the green light to begin the first stage of clinical trials for ReN001. Later in June, it secured site approval in Scotland, which paved the way to start patient recruitment.