The UK Medicines and Healthcare Products Regulatory Agency’s approval for the trial has been given subject to provision of data both from an ongoing preclinical 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 2009.
In this 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 Institute of Neurological Sciences, Southern General Hospital, Greater Glasgow and Clyde NHS Board, the company said.
According to the company, the trial is designed primarily to test the safety profile of ReN001 in ischemic 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, the company said.
Michael Hunt, CEO 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.