British researchers have been given a final approval nod to undertake clinical trials that will assess the potential of stem cell therapy to treat patients disabled by stroke.
The research being conducted as a joint effort by scientists of firm ReNeuron and a few doctors in Scotland will involve injecting neural stem cells developed from human foetuses into patients’ brains in the hope that they will repair areas damaged by stroke, thereby improving both mental and physical function.
This first-in-man clinical trial, most likely to begin in April 2010, with ReN001 stem cell therapy for stroke, will take place through the NHS at the Institute of Neurological Sciences, Southern General Hospital, Greater Glasgow and Clyde NHS Board. The trial is designed primarily to evaluate the safety profile of ReN001 in ischemic stroke patients at a range of cell doses, and a number of efficacy measures. The patients will thereafter be monitored for two years and if clinical outcomes are satisfactory, the company will then accelerate clinical development pathway focusing initially on more severely disabled stroke patients.
UK Gene Therapy Advisory Committee (GTAC) gave the approval for the commencement of phase I of the trial, much after ReNeuron received an okay from Britain’s main drugs watchdog back in January 2009.
Michael Hunt, chief executive officer of ReNeuron, said: “This final approval represents the culmination of many months of work in taking our ReN001 therapy through the regulatory pathway in the UK, a process untested by other stem cell therapy approaches of this type. We are therefore pleased to have in many ways pioneered this pathway for subsequent cell therapy applications, including, of course, those of ReNeuron’s other cell therapy candidates currently in development. We are also very pleased to be undertaking this ground-breaking clinical trial at a leading NHS hospital and we look forward to reporting on progress with the trial as it finally gets underway this year.”
Written by Snigdha Taduri for Biomed-ME