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Biotech gets final go-ahead for landmark stem cell trial

15 February 2010
Appeared in BioNews 545

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).

British stem cell trial approved
Al Jazeera |  10 February 2010
ReNeuron approved for world first stem cell trial
Financial Times |  10 February 2010
ReNeuron boost on nod for groundbreaking stem cell therapy trial
PharmaTimes |  10 February 2010
ReNeuron receives final regulatory approval to commence landmark stroke clinical trial in UK
ReNeuron |  10 February 2010
ReNeuron stem cell trial gets go-ahead
The Telegraph |  10 February 2010
Stem cell stroke trial gets final approval in UK
Nature |  10 February 2010
UPDATE 1-UK firm gets final green light for stem cell trial
Reuters |  10 February 2010
29 November 2010 - by Dr Rachael Panizzo 
A British man has become the first patient in the world to receive a pioneering stem cell therapy to repair brain damage caused by stroke....
19 July 2010 - by Dr Lux Fatimathas 
US and Japanese researchers have converted white blood cells (WBC) into stem cells...
19 January 2009 - by Ailsa Stevens 
Glasgow-based scientists have announced plans to trial a pioneering stem cell therapy for treating stroke patients later this year. The researchers hope that the therapy, which involves injecting embryonic stem (ES) cells into the brain, may help to reverse the symptoms of stroke, including mobility problems and...
14 July 2005 - by BioNews 
Leading UK stem cell company ReNeuron is planning a return to the stock market two years after it was removed from the market following a series of technical disappointments. The company was able to raise £21 million when it was initially floated in 2000 and was valued at around £70...
13 November 2000 - by BioNews 
The UK biotech firm ReNeuron, which wants to develop stem cell treatments for stroke, Parkinson's and Alzheimer's disease, has raised £19 million investment for its research. Chief executive Martin Edwards said: 'Market conditions have not been easy but what made a difference was that many fund managers had not heard...
11 September 2000 - by BioNews 
A UK biotech firm, ReNeuron, is developing a new treatment for stroke that involves a single injection of neural stem cells - cells that can grow into a variety of different nerve and brain cells. If clinical trials are successful, the company hopes to develop similar therapies for Parkinson's and Alzheimer's...
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