A research consortium in Europe plans to make tissue engineering that uses stem cells both clinically and commercially viable in the next four years.
The $32 million project, funded by the European Union, gathers 23 of Europe’s leading companies and research centers from 13 countries. It’s a who’s who of European biotech, with partners like the UK Centre for Tissue Engineering and the National Centre for Biomedical Engineering Science in Galway, Ireland.
The project hopes to give biomedical companies the jump start they need to turn a profit through tissue-engineering technologies — that is, producing skin, bone and cartilage for the treatment of diabetic wounds, shattered or diseased bones and many other conditions.
"Despite plenty of progress, tissue engineering has not achieved tremendous clinical success or commercial success," said Dr. David Williams, director of the UKCTE and scientific lead in the program, called Systems Approach to Tissue Engineering Products and Processes and thankfully nicknamed Steps.
"At the moment we can successfully produce a very small amount of tissue, but nothing good enough to replace large areas of skin or cartilage," he said. "We want scale up the process."
A lot of the science is there, he said, but gaps remain and some current methods are inefficient. For example, scientists can take stem cells from bone marrow or blood and get them to produce tissue, but it takes weeks or months. That makes it not only slow but expensive. "We want to produce tissue faster," Williams said.
The partners will work on a wide range of problems in parallel, tackling the logjams that face commercial tissue engineering. One partner, the National Center for Biomedical Engineering Science in Galway, Ireland, will look at the rapid manufacture of biocompatible scaffolds for large bones.
"Cells grow on the scaffold to produce a femur, or whatever," said Dr. Peter McHugh, research director for biomechanics at the NCBES. "We want to find the optimal scaffold and speed up the production process."
It’s a good example of what the project involves. Researchers need to differentiate stem cells to grow bone, find the right growth factors, develop a 3-D scaffold and then grow the cells on it. Each step needs to advance to create a viable product. A lot of the work will tweak existing techniques to make them commercially viable. "They are major tweaks," Williams said.
The research draws on a wide range of expertise, from gene therapy and molecular biology to engineering like rapid prototyping and materials science, making it one of the largest projects in tissue engineering in the world, McHugh said.
While the effort is extremely ambitious, Williams believes they will be testing new treatments in the clinic in four years.
The researchers also want to understand how stems cells grow into other types of cells. No one is sure how it works, Williams said. "We have empirically worked out how to do it in many cases. But this project wants to turn that empirical knowledge into a model."
The EU research will primarily use adult stems cells for their work, which avoids ethical problems, and Williams believes they’ll be more effective. Although embryonic stem-cell research is allowed in Europe, many European countries like Germany and Italy have a Catholic base. Embryonic stem-cell research requires destroying a very young embryo to obtain the cells, so the work is controversial to Catholics and other groups that believe life begins at conception.
Williams believes the United Kingdom is a leader in embryonic stem-cell research. One U.K. team recently developed populations of neural stem cells from a fetus. Meanwhile in the United States, President Bush forbids federal funding for any research that destroys embryos.
So, is the United States falling behind the rest of the world? "No, I don’t think so," said Williams, who believes states like California are very effective at funding this research.
"Actually it’s quite interesting. I’d say that America is probably scientifically ahead, while we find that Singapore and Shanghai and Seoul are practically ahead, because they have far less constraints. I think Europe represents a very, very good, solid middle ground — following normal ethical paradigms but developing practical applications."
Dr. William Wagner, deputy director of the McGowan Institute for Regenerative Medicine at the University of Pittsburgh, partly agrees, at least when it comes to the uncontroversial adult stem-cell research.
"But in embryonic, I think there’s some truth that we’re falling behind because there’s a lot that we can’t do," Wagner said. "I think, particularly in Asia, you see a lot of advances that are not happening in the U.S. If you polled U.S. scientists, I think there would be a sense that the U.S. is falling behind."
