Can Stem-cell Therapy Help Stroke Patients?

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Main Category: Stroke
Also Included In: Neurology / Neuroscience;  Stem Cell Research;  Clinical Trials / Drug Trials
Article Date: 19 Jan 2009 - 2:00 PDT

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Scientists in Glasgow, Scotland, will try to find out whether injecting cells developed from human fetuses into the brains of patients who have had a stroke might help them. If the stem cells can help the brain regenerate areas damaged by their stroke, patients would then hopefully regain their mobility and mental function.

The trial will be carried out by scientists at the University of Glasgow and ReNeuron Group plc.

The trial, which will commence in 2010, is expected trigger opposition from anti-abortion campaigners.

Recruitment for the Trial is expected to commence during the third quarter of this year. The study will consist of 12 patients, split into four groups of three, and will last two years. The scientists initially want to find out how safe the procedure is - however, even at this stage there is a good chance some of the patients will experience benefits.

Team leader, Dr. Keith Muir, Senior Lecturer in Neurology at the University of Glasgow, said "If it works, as it has done in animal model systems, it may allow new nerve cells to grow or regeneration of existing cells and actual recovery of function."

In this ground-breaking Phase I trial, the first of its kind using expanded neural stem cells, stroke patients will be treated with ReNeuron's ReN001 stem cell therapy at the University's Institute of Neurological Sciences, Southern General Hospital, Greater Glasgow and Clyde NHS Board. The first group will be given 2 million fetal cells - the doses will be increased for subsequent groups up to 20 million cells. Scientists believe that at the 20 million cell level patients should experience regeneration (rebirth of cells).

About 30% of current patients who had a stroke recover completely. However, the rest either die or become disabled for life. The only therapy that can help those permanently disabled is physiotherapy (physical therapy).

Dr. Muir explained that physiotherapy can help the brain to reorganize, but not to cause new nerve cells to grow. This trial might cause new cells to grow.

Reneuron PLC has announced today that the MHRA (Medicines and Healthcare Products Regulatory Agency) has approved the first-in-man clinical trial for the treatment of patients who have been left disabled by an ischemic stroke - the most common stroke. Public records indicate that stroke is the third largest cause of adult disability in the developed world.

MHRA approval for the trial was granted subject to provision of data both from an ongoing pre-clinical study and from the long term follow-up of trial participants.

Reneuron Plc. says patients will not require immunosuppression following treatment.

"Stem cell treatment offers the potential to repair brain tissue lost as a result of stroke. We are very excited at the opportunity to undertake this, the first clinical trial involving neural stem cell therapy in stroke. At this stage, we are primarily seeking to establish the safety and feasibility of this form of treatment, and if successful, we hope that it will lead on to larger studies looking at the effects of the treatment on patient recovery," said Dr. Keith Muir.

Michael Hunt, CEO, ReNeuron, said "This regulatory approval marks the first step in the process of testing the safety and potency of our lead ReN001 stroke therapy at a clinical level. It is the most important milestone in ReNeuron's history thus far and also represents a significant development in the wider field as regards the translation of exciting 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."

Links
-- Reneuron Plc.
-- Dr Keith Muir MB, ChB, MSc, MD, FRCP
-- University of Glasgow, Division of Clinical Neuroscience
-- What are Stem Cells?

Source - University of Glasgow

Written by Christian Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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