IoP 'start-up' company initiates world's first in-human stem cell trial
18 November 2010
An Institute of Psychiatry (IoP) ‘start-up’ biotech company, ReNeuron, has initiated the world’s first fully regulated clinical trial of a neural stem cell therapy in a brain disorder. The Phase 1 trial of ReNeuron’s ReN001 stem cell therapy is being administered to patients left disabled by ischaemic stroke and the first patient has undergone the successful surgical procedure at Glasgow’s Southern General Hospital.
The PISCES study (Pilot Investigation of Stem Cells in Stroke) will primarily test the safety profile of the cells, but measures of efficacy will also be included. The ReN001 cells were administered by direct injection into the affected region of the brain in a routine surgical procedure. The patient will be monitored closely for two years, with longer term follow-up procedures in place thereafter.
ReNeuron was formed in 1998 by three Institute scientists, Jeffrey Gray, John Sinden, and Helen Hodges and is the first company to have received regulatory approval for any stem cell-based clinical trial in the UK. The company retains its strong association with the IoP at King's through Prof Jack Price who acts as a Consultant to ReNeuron and helped develop the neural stem cells that have gone into this trial.
Professor Price said: 'We are pleased that the first patient in the PISCES trial has undergone surgery successfully and we hope that in future it will lead on to larger studies to determine the effects of stem cells on the disabilities that result from stroke. We are very proud to have contributed to this significant milestone in the progress towards stem cell therapeutics.'
Stroke is the third largest cause of death and the single largest cause of adult disability in the developed world. Ischaemic stroke is the most common form of the condition and is caused by a blockage of blood flow in the brain as opposed to a haemorrhagic or bleeding stroke.
Some of the pivotal pre-clinical studies were conducted in collaboration with ReNeuron in the IoP’s Centre for the Cellular Basis of Behaviour (CCBB) by Dr Mike Modo’s research group. The CCBB is a section of the Neuroscience department at the Institute. The stem cell group does basic and translational research to understand the therapeutic potential of stem cells in neurodegenerative disease. The multidisciplinary team employs techniques from molecular genetics, cell biology, neuroimaging, and behavioural science in an effort to bring stem cell therapies into clinical practice. This work is funded by the Charles Wolfson Charitable Trust, the European Commission, the US National Institutes of Health, and Research Councils.