ReN001 for Stroke
A stroke occurs when blood flow leading to, or in, the brain is blocked (ischaemic stroke) or a blood vessel in the brain ruptures (haemorrhagic stroke), which can result 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 150,000 people suffer a stroke each year in the UK, and over 700,000 people in the US. Approximately 80% of these strokes are ischaemic in nature. Our ReN001 stem cell therapy seeks initially to treat those patients who have suffered an ischaemic stroke and have been left disabled by it. These patients constitute approximately one half of stroke survivors.
The annual health and social costs of caring for disabled stroke patients is estimated to be in excess of £5 billion in the UK, with stroke patients occupying 25 per cent of long term hospital beds. In the US, the annual direct and indirect costs of stroke are estimated to be in excess of US$50 billion. The type of stroke treatment a patient should receive depends on the stage of disease. Generally there are three treatment stages of stroke:
Prevention - treatments to prevent a first or recurrent stroke are based on treating associated risk factors, e.g. high cholesterol, smoking and diabetes;
Treatment immediately after the stroke; acute-phase stroke treatments attempt to arrest a stroke whilst it is happening by dissolving the blood clot that has caused the infarct; and
Post stroke rehabilitation - the aim of post stroke rehabilitation is to improve both functional and cognitive recovery in the patient some weeks or months after the stroke event.
It is this third treatment stage that our ReN001 stem cell therapy seeks to address. A number of treatments exist or are in development to treat stroke patients in the acute phase. However, there are currently no therapies available for patients who have a stable and fixed neurological deficit following a stroke. Our ReN001 cell therapy for stroke consists of a neural cell line, designated CTX, which has been generated using our proprietary cell expansion and cell selection technologies and then taken through a full manufacturing scale-up and quality-testing process. As such, ReN001 is a standardised, clinical and commercial-grade cell therapy product capable of treating all eligible patients presenting.
ReN001 has been shown to reverse the functional deficits associated with stroke disability when administered several weeks after the stroke event in relevant pre-clinical models. Extensive pre-clinical testing also indicates that the therapy is safe, with no adverse safety effects arising from the administration of the cells. Clinically, the potential of the ReN001 treatment is to engender a degree of recovery of function in disabled stroke patients sufficient to give them an improved quality of life and a reduced reliance on health and social care.
A ground-breaking first-in-man clinical trial with ReN001 is now in long term follow up. The PISCES study (Pilot Investigation of Stem Cells in Stroke) is the world's first fully regulated clinical trial of a neural stem cell therapy for disabled stroke patients and ReNeuron is the first company to have received regulatory approval for any stem cell-based clinical trial in the UK.
For further information regarding the PISCES clinical trial with ReN001 please click here
A multi-site Phase II clinical trial in the UK has commenced. This will examine the efficacy of our ReN001 stem cell therapy in patients disabled by ischaemic stroke. The trial is designed to recruit from a well-defined population of patients between two and three months after their stroke, which we and our collaborators believe will be the optimum treatment window for our therapy.