The trial is designed to recruit a total of 12 men (> 60 years of age). Participants will receive a direct injection of ReN001 cells into the affected brain region between six and 24 months following their stroke. While the study will primarily evaluate the safety of the stem cells, a number of efficacy measures will also be evaluated over two years of follow-up.
The first patient was treated with the stem cells at the Institute of Neurological Sciences, Southern General Hospital, in Glasgow, Scotland; and was safely discharged two days after the straightforward neuro-surgical procedure. Southern General is one of Europe’s most innovative and well-recognized stroke treatment centers and is perhaps best known as the place where the Glasgow Coma Scale was developed.
Assuming a satisfactory independent Data Safety Monitoring Board review of the first patient’s progress in December 2011, the additional patients will be treated shortly thereafter. Subject to satisfactory safety data ReNeuron intends to pursue an accelerated clinical development pathway with ReN001, focusing on particular stroke patient groups who are expected to most benefit from the therapy.
Principal investigator Professor Keith Muir suggested that “if the therapy works it may allow new nerve cells to grow or regeneration of existing cells and actual recovery of function in patients who would not otherwise be able to regain function.”
Stroke is the third largest cause of death and the single largest cause of adult disability in the developed world. It occurs when blood flow leading to, or in, the brain is blocked (ischemic stroke) or a blood vessel in the brain ruptures (hemorrhagic stroke). This results in damage to the nerve cells in the brain and a loss of bodily functions.
Stroke is the single largest cause of adult disability in the developed world. Over 700,000 people suffer a stroke each year in the US, of which, approximately 80% are ischemic in nature.
In the US, the annual direct and indirect costs of stroke are estimated to be in excess of $50 billion.
The type of stroke treatment a patient should receive depends on the stage of disease:
- Prevention – treatments to prevent a first or recurrent stroke are based on treating associated risk factors, e.g. high cholesterol, smoking and diabetes
- Immediately after the stroke – treatments attempt to arrest a stroke whilst it is happening by dissolving the blood clot that has caused the infarct
- Post stroke rehabilitation – aims to improve both functional and cognitive recovery in the patient weeks or months after the event.
ReN001 stem cell therapy seeks initially to target ischemic stroke patients in the third stage. These patients constitute approximately one half of stroke survivors.
SRxA’s Word on Health will be following this story and will bring you updates as they happen.