The UK Gene Therapy Advisory Committee (GTAC) has given ReNeuron, a British biotech company, permission to begin the first ever clinical trial into using embryonic stem cells as a stroke treatment this year.
The much-awaited GTAC approval was the final barrier to ReNeuron's trial going ahead. It comes after ReNeuron secured UK Medicines and Healthcare products Regulatory Agency (MHRA) approval in January 2009, after a cool response in 2005. The US drug regulator, the Food and Drug Administration (FDA), meanwhile, kept delaying approval, according to the Financial Times.
'In many ways, ReNeuron has set the regulatory pathway in the UK for cell therapy trials of this type, and we are delighted to have been given the opportunity to move ReN001 into its clinical phase on home territory in the UK', Michael Hunt, chief executive of ReNeuron, previously commented.
ReNeuron's ReN001 treatment aims to use the pluripotent capability of stem cells. They hope that the stem cells will be stimulated to become new healthy brain tissue and give the patient normal brain function again. Currently over 50% of stroke patients are left with a permanent disability, which costs the NHS an estimated £5 billion per year. Often patients do not get to hospital in time to receive the main treatment - thrombolysis (drugs to break up blood clots) drugs - for ischeamic stroke, the most common type. These need to be administered shortly after the stroke occurred.
The clinical trial will be managed by Keith Muir, a neurologist at Glasgow University. ReN001 will be injected into the affected areas of ischeamic stroke patients six to 24 months after their attack. It will assess what strength of treatment is safe and what dose gives the best effects for the patient. If the results are encouraging, ReNeuron hope to move into trials treating severely disabled stroke patients.
The trial has attracted controversy, according to Al-Jazeera, because stem cells need to be harvested from human embryos so there is still opposition to their use in medicine. Pro-life group Un-Born child, have described the trial as 'sick'. 'It is unethical in every way - killing one member of the human race to help another. We are totally opposed to this', the BBC reportedly quoted a spokesperson as saying.
Stroke is the term used to describe the loss of brain function that occurs after blood supply to the brain is reduced or stopped completely either by blockage via a blood clot (ischeamic) or disruption by a blood vessel bursting (haemorrhagic).