A Europe-wide ban on patents derived from human embryonic stem cells threatens to undermine a pioneering British research project to produce industrial-scale quantities of synthetic blood for hospital transfusions.
The scientist in charge of an attempt to mass-produce human red blood cells from stem cells derived from spare IVF embryos said the European Court of Justice's patent ruling could force him to switch to non-embryonic stem cells.
A team of UK researchers, funded by the Wellcome Trust medical research charity, is trying to develop stem cells derived from spare IVF embryos to make large volumes of red blood cells for use in transfusions.
They have successfully produced oxygen-carrying red cells and are trying to scale up production to make industrial quantities of substitute blood, but will almost certainly need further investment from the private sector.
However, earlier this month the European Court of Justice ruled that it was not possible to patent inventions using human embryonic stem cells, a decision widely condemned by leading stem-cell scientists in Britain who argued that it would stymie private investment in this new area of medical research.
"Unfortunately it will make it less likely that companies in Europe will invest in the research to develop treatments to use embryonic stem cells for treatment of human diseases," said Professor Sir Ian Wilmut of Edinburgh University, who cloned Dolly the sheep.
Professor Marc Turner, director of the Scottish Blood Transfusion Service in Edinburgh, told The Independent that the ban on patents using human embryonic stem cells could also jeopardise his project on synthetic blood because it is likely to affect future investment by private organisations.
"The NHS is not in the business of developing products and to see this technology going forward we would need private investment. In the broadest sense, the patent ruling will have an impact on possible investment by the private sector," he said.
Rather than using stem cells derived from spare IVF embryos, the research team, based in Edinburgh and Glasgow, is considering shifting to stem cells derived from human adult cells that have been transformed genetically by a technique known as induced pluripotent stem (iPS) cells, he said.
"The ruling will have an effect in that we are now considering the possibility of adapting the project appropriately. We may move from embryonic stem cells to [non embryonic] iPS cells," Professor Turner explained.
The aim of the £3m project is to develop an alternative source of O-negative blood, the universal donor group that can be transfused into the vast majority of the population without fear of rejection.
More than 100 spare IVF embryos from fertility clinics have been used to establish several embryonic stem cell lines that replicate continuously in the laboratory. One cell line, known as RC-7, has been successfully converted into mature red blood cells, however tests have shown that the line of cells is not the O-negative universal donor.
Professor Turner said there are still technical problems with the technique, such as the ability of the red cells to eject their nucleii correctly, but he hopes to begin clinical trials in two or three years.