The first human trials of synthetic blood look set to go ahead in the UK.
The Medicines and Healthcare products Regulatory Agency (MHRA) has granted scientists at the Scottish Centre for Regenerative Medicine (SCRM) a licence to manufacture blood from stem cells. The licence allows the production of blood for use in clinical trials, rather than just research purposes.
Professor Marc Turner, project leader and medical director for the Scottish National Blood Transfusion Service, told the Scotsman newspaper that the licence was 'absolutely crucial' to advancing their work. He added that trials could start in the next two to three years.
In 2010, Professor Turner's team reported producing substantial quantities of blood cells from stem cells (reported in BioNews 572). This was seen as a milestone towards the ultimate goal of producing a limitless supply of artificial blood, which would drastically reduce the need for donations.
Originally, Professor Turner told the Scotsman, the project 'used human embryonic stem cell lines and one of the problems with using those lines is you can't choose what the blood group is going to be'. Adult donors, on the other hand, can be selected for 'the specific blood type' required. In any eventual clinical setting this would likely be the 'universal donor' blood type, O negative, although a special licence has been granted by the MHRA allowing production of therapies for specific patients.
The technology at the SCRM allows induced pluripotent stem cells to be derived from blood or skin samples. Ultimately, if clinical trials were successful, the manufacture of synthetic blood might not only reduce dependency on donated blood but also reduce the risk of transmission of blood-borne infections. Life-saving transfusions could be available at the scene of accidents and in countries where infection control is problematic.
However, scaling up production to the level required by national health systems would be a considerable challenge. Professor Turner emphasised that he was leading a long-term project. 'We do not want people to stop donating blood', he said.
The SCRM facility belongs to Edinburgh University and is jointly operated by Roslin Cells and the Scottish National Blood Service. Janet Downie, chief operating officer of Roslin Cells, said she was 'delighted to have reached this stage and look forward to welcoming new customers to our state-of-the-art facility'.
The MHRA licences additionally allow the expansion of current research at the SCRM looking at stroke, Parkinson's disease, diabetes and cancer.