BioWorld Today Correspondent

LONDON – ReNeuron Group plc reported that the first patient has been treated and discharged in the world's first regulated trial of a neural fetal stem cell therapy in the treatment of disability caused by ischemic stroke.

This is more than four years after the company first applied for permission to conduct a trial and CEO Michael Hunt said the start of the study, "Is a major and hard-won milestone for ReNeuron." He added, "Our thanks and best wishes go to the first patient and his family for their participation in this important and ground-breaking clinical trial."

The patient underwent surgery to administer the ReN001 by direct injection into the affected region of the brain at the Institute of Neurological Sciences, Southern General Hospital, in Glasgow, and will now be monitored for two years, with longer-term follow-up thereafter.

In this Phase I PISCES study (Pilot Investigation of Stem Cells in Stroke) Guildford, UK-based ReNeuron's ReN001 stem cell therapy is being administered to patients who have been left disabled by an ischemic stroke, the most common form of the condition. The principal investigator, Keith Muir, professor of clinical imaging, Division of Clinical Neurosciences at Glasgow University, said that apart from safety, the trial aims to "establish the feasibility of stem cell implantation."

While the trial will primarily test the safety profile of a range of cell doses of ReN001, a number of efficacy measures will also be evaluated.

The independent data safety monitoring board will review the progress of the first patient in December, before giving the go-ahead for the remainder of the first dose cohort to be treated. If there are no safety concerns, ReNeuron then intends to pursue an accelerated clinical development pathway, focusing on more severely disabled stroke patients, who are expected to see most benefit from the therapy.

In the PISCES Phase I trial, a total of 12 patients are due to receive the ReN001 therapy between six and 24 months after their stroke. The numerous and detailed preclinical studies that ReNeuron has carried out indicated the therapy offers the potential for a degree of recovery of function in disabled stroke patients, resulting in greater independence and quality of life. In animal models, ReN001 reversed functional deficits caused by stroke when administered several weeks after the event. The proposed mode of action is that the cells stimulate endogenous neurogenesis. The implanted cells are eventually cleared from the body.

The ReN001 cells being used in the initial clinical trial are from existing manufactured cell banks that will form the basis of the marketed product. There will therefore be no need to re-derive and test new ReN001 cell lines for subsequent clinical trials or for the market. ReN001 is a standardized, clinical and commercial-grade cell therapy product that can be used to treat all eligible patients.