Economic regeneration is the name of the game for Japanese Prime Minister Shinzo Abe, and cellular regeneration is one way to play it.
The government is pushing through bills to fast-track regulatory approval for cell-based products and set new research guidelines. It’s also funding a $1.12 billion study of a type of stem cell free from ethical concerns over embryo harvesting that have dogged the science for more than a decade.
Abe aims to cement Japan’s leadership in a field of research that last year garnered the nation’s first Nobel Prize for medicine in a quarter of a century. Not only academic bragging rights are at stake: the government wants new industries to wean the world’s third-biggest economy from its dependence on autos and estimates stem cells’ potential to rejuvenate worn-out body parts or reverse degenerative diseases such as Alzheimer’s may yield $380 billion in sales by 2050.
Lawmakers will debate legislation as early as this month to make the approval process for cell therapies faster than in the U.S. and U.K. That marks a sea-change from the kind of conservative regime that held back Japanese scientists from research into cells derived from human embryos, said Alan Colman, executive director at Singapore Stem Cell Consortium.
“They don’t want to repeat that for the innovation Japan was totally responsible for,” said Coleman, who helped pioneer cloning techniques that created Dolly the sheep in 1996. “They are trying to reinvent themselves and show themselves to be progressive and sensible and not inhibitory.”
Investor optimism at the prospects for Japan’s cell technology can be seen in some stocks. Japan Tissue Engineering Co. (7774), which makes cultured cartilage and skin tissue, has soared more than five-fold this year. ReproCell Inc. (4978), the first company licensed to make iPS cells, is almost three times higher than its initial public offering price in June.
In July, the Health Ministry gave the go-ahead for the world’s first clinical trial on humans with stem cells made using the Nobel Prize-winning technique of Shinya Yamanaka.
In an embryo’s early stages, stem cells are pluripotent, meaning they can become any type of tissue in the body. As the embryo develops, they begin to specialize, or differentiate, into building blocks for the body’s different structures.
Yamanaka showed how these later-stage cells in mice can be reprogrammed into what are termed induced pluripotent stem cells, or iPS cells.
While New York-based Pfizer Inc. (PFE) and Advanced Cell Technology Inc. (ACTC) of Marlborough, Massachusetts, are already conducting trials on humans, these use cells harvested from embryos. As well as sidestepping ethical issues this raises, the Japanese technique reduces risks that immune systems will reject implanted cells because they are taken from patients’ own bodies.
‘Dominate the World’
“I want us, Japan, to dominate the world in the area of therapies using iPS cells,” Masayo Takahashi, who is leading the study at government-funded research center Riken, said in an interview. “It feels like the government is opening one door after another to help.”
In the trial, stem cells from the skin of six patients suffering from a severe form of macular degeneration, the leading cause of blindness in the elderly, will be coaxed into becoming cells for the eye. As early as mid-2014, these will then be planted behind the patients’ retinas to restore vision.
The study will monitor the results over four years, primarily to establish the technique’s safety.
“Very little is understood about the risks with these therapies,” said Paul Knoepfler, an associate professor at the University of California Davis School of Medicine. “There is always a risk when you link economic growth to scientific development. There is a lot of pressure to get stem-cell treatments out there very quickly.”
Retina Institute Japan K.K., a commercial venture of Riken, estimates the market for the treatment at $21 billion.
Health was a key area, along with agriculture and clean energy, Abe highlighted in his June plan to spark growth in an economy that the Cabinet Office says is smaller now than a decade ago. It may also help lessen dependence on automakers, which accounted for 40 percent of production growth from 2000-2007, economy ministry data show.
The government will allocate a special budget of 1 trillion yen ($10 billion) for the year ending March 2014 to support the new areas, Kyodo News said on Aug. 2. Science Minister Hirofumi Shimomura in January committed about 110 billion yen over the next decade on the iPS research.
Recent advances aside, history suggests a long fight ahead for stem-cell domination.
Since researchers led by James Thompson at the University of Wisconsin-Madison first isolated human embryonic stem cells in 1998, there has been no publicized success in using them on humans. Menlo Park, California-based Geron Corp. (GERN) in January quit its first trial to develop spinal-cord injury treatment because of costs and sold the assets to BioTime Inc. (BTX)
Hopes that cellular industries can fill a gap left by Japan’s shrinking technology sector may also be overblown: the government’s $380 billion global market estimate is about the same as a year’s sales at Toyota Motor Corp. and Honda Motor Co.