World First For Glasgow University As Stem Cell Therapy Trials Are Approved
Article Date: 03 Feb 2009
The University of Glasgow and the ReNeuron Group plc are to begin a ground-breaking clinical trial with stem cell therapy for stroke.
ReNeuron announced today (19 January 2009) that it has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to commence a first-in-man clinical trial for the treatment of patients who have been left disabled by an ischaemic stroke, the most common form of the condition. Stroke is the third largest cause of death and the single largest cause of adult disability in the developed world.
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 Principal Investigator for the trial is Dr Keith Muir, Senior Lecturer in Neurology at the University of Glasgow. MHRA approval for the trial has been given subject to provision of data both from an ongoing pre-clinical study and from the long term follow-up of trial participants. Following successful completion of the ethics approval process which is currently underway for the trial, patient recruitment is expected to commence in the second quarter of this year. The trial is designed primarily to test the safety profile of ReN001 in ischaemic stroke patients at a range of cell doses, but a number of efficacy measures will also be evaluated over the course of the trial. The ReN001 cells will be administered by direct injection into the affected region of the brain in a straightforward surgical procedure.
Importantly, the nature of the procedure and the characteristics of the ReN001 cells mean that the patients will not require immunosuppression following treatment, thus eliminating the safety risks typically associated with immunosuppression regimens. Patients in the trial will be monitored for one year, with longer term follow-up procedures in place thereafter.
Dr Keith Muir said: "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."
Michael Hunt, Chief Executive Officer of 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."
Article Date: 03 Feb 2009
The University of Glasgow and the ReNeuron Group plc are to begin a ground-breaking clinical trial with stem cell therapy for stroke.
ReNeuron announced today (19 January 2009) that it has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to commence a first-in-man clinical trial for the treatment of patients who have been left disabled by an ischaemic stroke, the most common form of the condition. Stroke is the third largest cause of death and the single largest cause of adult disability in the developed world.
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 Principal Investigator for the trial is Dr Keith Muir, Senior Lecturer in Neurology at the University of Glasgow. MHRA approval for the trial has been given subject to provision of data both from an ongoing pre-clinical study and from the long term follow-up of trial participants. Following successful completion of the ethics approval process which is currently underway for the trial, patient recruitment is expected to commence in the second quarter of this year. The trial is designed primarily to test the safety profile of ReN001 in ischaemic stroke patients at a range of cell doses, but a number of efficacy measures will also be evaluated over the course of the trial. The ReN001 cells will be administered by direct injection into the affected region of the brain in a straightforward surgical procedure.
Importantly, the nature of the procedure and the characteristics of the ReN001 cells mean that the patients will not require immunosuppression following treatment, thus eliminating the safety risks typically associated with immunosuppression regimens. Patients in the trial will be monitored for one year, with longer term follow-up procedures in place thereafter.
Dr Keith Muir said: "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."
Michael Hunt, Chief Executive Officer of 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."