Glasgow University neurologist Dr Keith Muir (right) will lead the study into trials of stem cell company ReNeuron, winning approval to trial its pioneering ReN001 therapy after five years of applications, and will begin with a dozen patients in Scotland

.The company's chief scientist, John Sinden, said that the trial will last for two years and start in the second quarter of 2010.

Michael Hunt, CEO (left) of Guildford based ReNeuron said “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.”

The Medicines and Healthcare Regulatory Agency (MHRA) granted approval in January 2009, http://www.computescotland.com//stem-cells-in-regulatory-legal-and-ethical-stranglehold-1907.php but final endorsement was needed from the Gene Therapy Advisory Committee, which is the national research ethics body for stem cell clinical trials.

The aim of the initial Phase I clinical trial with ReN001 is to evaluate safety of the implantation technique and  establish the side effect profile associated with the implantation of ReN001 stem cells in patients who have suffered an ischaemic stroke.

Two years work ahead
ReNeuron aims to collect preliminary efficacy data by evaluating any improvement reported in stroke-specific assessments that will be made regarding neurological function on an on-going basis throughout the study.



The actual surgical technique that will be used in the ReN001 clinical trials known as stereotactic injection, is a well-established and relatively straightforward procedure in neurosurgery. With the aid of a stereotactic co-ordinate frame in place around the patient's head, the neurosurgeon will use a special cannula to implant the ReN001 cells directly into the target brain region through a single, small craniostomy burr hole in the skull.

The implantation procedure takes between one and two hours, depending on the cell dose administered. The patient will remain in the hospital overnight and will normally be discharged the morning after surgery.

Patients in the proposed Phase I trial will be followed up over a two year period to evaluate the safety of the ReN001 therapy and any potential improvement in neurological function.

These clinical assessments will involve scoring against several stroke-specific scales as well as a battery of other tests designed to evaluate both motor and cognitive function over time. Ongoing monitoring of the patients will also continue in the longer term following the two year end-point.