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First Ever Stem Cell Clinical Trial Patient Receives Expanded Neural Stem Cells

October 08, 2017

The first ever clinical trial using neural stem cell therapy has begun with one patient in the UK, ReNeuron Group plc announced today. Known as the Pilot Investigation of Stem Cells in Stroke (PISCES) study, it is the first ever fully regulated neural stem cell therapy clinical trial for patients disabled by stroke. The company informs that stroke is the main cause of adult disability in industrial countries, and the third cause of death.

The patient, an elderly Scotsman, was discharged two days after receiving a neuro-surgical procedure using the ReN001 cells, in what ReNeuron describes as "straightforward". This was done at the Institute of Neurological Sciences, Southern General Hospital, Greater Glasgow and Clyde NHS Board. He was given very low doses. According to doctors, the patient is doing well.

The aim of this Phase I trial is to determine the safety of ReN001 on patients who have become disabled due to ischemic stroke, which accounts for about 75% of all strokes. Ischemic stroke occurs when a thrombus (blood clot) forms, blocking blood flow to part of the brain. Sometimes a clot may form elsewhere in the body and breaks off and becomes free-floating, this is called an embolus. The wandering clot may make its way in the bloodstream to the brain where it can cause ischemic stroke.

The trial will also test a series of efficacy measures. Trial participants will be closely monitored for two years, and then periodically after that.

ReNeuron says that if the independent Data Safety Monitoring Board is satisfied with this first patient's progress in December, the rest of the first dose cohort will receive treatment shortly afterwards. The company says it aims to pursue an accelerated clinical development pathway, concentrating on specific stroke patient types who may derive the most benefit from ReN001, if this first study is successful.

Principal Investigator for the trial, Dr. Keith Muir said: "We are pleased that the first patient in the PISCES trial has undergone surgery successfully. Stroke is a common and serious condition that leaves a large number of people with significant disability. 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." Michael Hunt, Chief Executive Officer of ReNeuron, said: "The initiation of the PISCES clinical trial is a major and hard-won milestone for ReNeuron and a significant milestone in the development of therapies to address the severely disabling effects of ischaemic stroke. We are delighted to be working with Professor Keith Muir and his team at one of Europe's pre-eminent stroke treatment centres and, in so doing, helping to promote the uptake of clinical innovation in the NHS system. Our thanks and best wishes go to the first patient and his family for their participation in this important and ground-breaking clinical trial." The company says a total of 12 patients will have received ReN001 cell therapy between six months and two years after having suffered a stroke. They will all be men over 60 years of age who have improved very little or not at all, an ideal group to evaluate the safety of the procedure, experts say.

Put simply - the surgical procedure involves injecting ReN001 (ReNeuron's neural stem cells) into the patient's brain. Hopefully, these neural stem cells will repair areas that were damaged by stroke, resulting in better physical and mental functioning.

The stem cells in this case were derived from human fetuses.

Apparently, the company had initially intended to carry out the trial in the USA. However, after FDA (Food and Drug Administration) regulator delays, ReNeuron decided to do it in the United Kingdom.

Approximately 795,000 Americans have a stroke each year, of which about 185,000 are recurrent attacks. The vast majority of people who get stroke are aged over 65 years. Stroke risk doubles for each decade after the age of 55. About 150,000 British people suffer from stroke each year.

About half of all stroke survivors have to cope with some kind of permanent disability caused by brain damage. 25% of long-term hospital beds in the UK are occupied by stroke patients.

Anti-clotting agents, if administered during the acute phase of an ischemic stroke - the first few hours - may dissolve the clot and restore blood flow to the brain. This is the only current treatment for ischemic stroke. Unfortunately, a significant number of patients do not get this treatment early enough.

Source: ReNeuron