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World's first stem cell trial for stroke likely to get green light

Published on 19/01/07 at 10:25am

A cutting-edge stem cell clinical trial for chronic stroke patients looks set to go ahead later this year.

Biotech company ReNeuron, based in Surrey, has filed ReN001, a neural stem cell treatment for stroke, with US regulators for phase 1 trials.

It is the world's first such filing concerning a neural stem cell treatment for a major neurological disorder.

Although the FDA has asked for additional information before granting the application, ReNeuron's chief executive, Michael Hunt, is highly confident that permission will be granted for the trial to proceed in the next few months.

He told Pharmafocus: "The additional points raised by the FDA were largely as expected and are readily addressable. We believe the additional pre-clinical trials we are currently undertaking will answer the main points raised by the FDA and we are highly confident that the trial will go ahead."

He added: "We would have been very surprised if the FDA had approved our application within the initial 30 days following our application, as stem cell technology is still regarded as controversial in some quarters."

Hunt went on to stress: "All we are doing now is going through a 'topping up' process of information to satisfy the FDA. We are working through the details of the trial and can draw a lot of comfort that the FDA is working with us all the way."

The trial will initially involve around a dozen patients who have suffered a debilitating stroke within the previous 12 months and whose conditions are stable. ReNeuron is hoping to show that ReN001 will demonstrate marked improvements in physical movement, speech and a general improvement in quality of life.

"We are taking a conservative approach," Mr Hunt said. "Our first priority is patient safety. The prize is some way off, but we are on the road to it."

Once the trial is under way, it will act as a validation process for four other phase I stem cell trials planned by ReNeuron in diabetes, Huntington's and Parkinson's disease as well as retinal disorders.

Hunt said the company hoped to file these trials with the FDA before the summer.

First Minister, Jack McConnell, has announced a £59 million grant to help set up a new stem cell research centre in Edinburgh. The Scottish Centre for Regenerative Medicine (SCRG) will draw together the international reputation of scientists at the Institute for Stem Cell Research, also based in the city, the Roslin Institute and the University of Edinburgh's medical school.

The SCRG will house 220 international academic researchers and will carry out cutting-edge development and manufacture of stem cells. It is due to come on line in 2010.

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