The Yomiuri Shimbun.
TOKYO — The Health, Labor and Welfare Ministry has decided to promote the use of induced pluripotent stem cells by proposing new legislation for regenerative medicine, The Yomiuri Shimbun learned Friday.
Provisions to enable the iPS cells extracted from patients by medical institutions to be processed by outside businesses will be incorporated into a new bill to be submitted to the current Diet session.
The ministry also aims to revise the Pharmaceutical Affairs Law so that such products as cells for transplant can be approved within a short period.
The new legislation and legal revision are part of the ministry’s efforts to achieve early practical application of regenerative medicine.
Regenerative medicine refers to treatment methods to regenerate cells and tissue damaged by disease or injury. Doctors extract healthy cells from patients to process them into iPS and other cells. Processed cells will be used to produce transplant cells and tissue for areas such as nerves and skin.
While regenerative medicine using iPS cells has neared practical application due to rapid advances in research, no clear legal provisions exist among current laws and ordinances that would allow doctors to commission the processing of cells extracted for regenerative medicine to outside private firms.
The new law envisioned by the ministry for regenerative medicine would call for setting safety standards for the management of cells by firms that will subcontract cell processing from medical institutions.
Specifically, the law would make it mandatory for such firms to hire engineers who have expertise in cell-processing technology, take all possible measures to prevent infection and formulate internal regulations on process management.
The firms would be permitted to subcontract the cell processing pending ministry approval of their facilities.
By commissioning the cell processing to outside entities, doctors would be able to concentrate on the treatment of patients. Thus the planned legislation is aimed at speeding up clinical research on regenerative medicine and fostering a new cell-processing industry.
Under the revised Pharmaceutical Affairs Law, products for regenerative medicine would be approved conditionally after their safety is established in clinical trials requiring fewer trial participants than needed under the current approval system.
The new system would also call for follow-up inspections of the safety and effectiveness of regenerative medicine products.
Medical institutions would be obliged to give patients explanations, obtain their approval and keep records on regenerative medicine. A formal approval to undertake treatment would be given after safety and effectiveness are confirmed.
A study panel of the industry ministry said Friday the domestic market for regenerative medicine will grow to 1.6 trillion yen by 2030.
According to the study group of the Economy, Trade and Industry Ministry, the demand for medical products in regenerative medicine, such as organ cells grown from iPS cells, will be about 1 trillion yen, including medical treatments using the products.
Related businesses such as devices and containers to culture iPScells will also grow to about 550 billion yen, the group said in its report.
The Study Group on Commercialization and Industrialization of Regenerative Medicine is headed by Prof. Mitsuo Okano of Tokyo Women’s Medical University.
In a breakdown of the market, the group said businesses involved in transplanting eye cells into eyes of age-related macular degeneration (AMD) patients are slated to grow to the 100 billion yen level and those involved in neural cells used in the treatment of Parkinson’s disease are expected to grow to 110 billion yen.
The study group also came up with a forecast of the extent to which treatments using regenerative techniques will be commercialized.
The market is expected to further grow to the 3.8 trillion yen level by 2050, the group added.
Science/Technology
Legal rules proposed for cell therapies
- Science/Technology
-
-
Toddler is youngest to ever get lab-made windpipe
CHICAGO — A 2-year-old girl born without a windpipe now has a new one grown from her own stem cells, the youngest patient in the world to benefit from the experimental treatment.
-
EPA methane report further divides fracking camps
PITTSBURGH — The Environmental Protection Agency has dramatically lowered its estimate of how much of a potent heat-trapping gas leaks during natural gas production, in a shift with major implications for a debate that has divided environmentalists: Does the recent boom in fracking help or hurt the fight against climate change?
-
NASA chief: Visiting an asteroid is all agency can afford
WASHINGTON - A NASA plan to send astronauts to an asteroid was met with skepticism Wednesday when NASA Chief Charlie Bolden presented the idea to top space officials in Congress - though their doubts may not be enough to sink the program.
-
At Navy Yard, ’living lab’ of energy efficiency
PHILADELPHIA - Building 661 at the Navy Yard was never a thing of beauty. Built in 1942, during the first months of U.S. involvement in World War II, the brick-and-concrete structure’s purpose was to house an indoor swimming pool, basketball courts, and offices, a function it pragmatically performed until the Philadelphia Naval Shipyard closed in 1995.
-
Expo seeks to inspire new generation of robot-builders
Robots that can transfer plastic rings. Robots that can toss Frisbees into targets. Robots that can climb, swim, dance, or make music. Robots that can clean up a nuclear plant after a Fukushima-style disaster, sparing human beings the risk of radiation poisoning.
-
UN official hopeful about 2015 climate talks
DUBAI, United Arab Emirates — Governments are more serious and the impact of climate change is more dramatic, improving chances of a groundbreaking global warming pact in 2015 in contrast with the failure of such an effort in 2009, the U.N. climate chief said Tuesday.
-
Whiz kids show their stuff at White House science fair
In his dark blue business suit, President Barack Obama climbed onto a bicycle anchored to the ground outside the White House. He pedaled in his polished dress shoes, generating electricity to run a water sanitation system built by a group of Florida teenagers.
-
How Rocking a Baby Is Like Holding a Kitten by the Neck
A human mother rocking a baby in her arms and a cat carrying her kitten by the scruff of its neck have the same physiological effect on both young animals and probably stem from the same maternal instinct to protect their young. That's the conclusion of a new study, which for the first time has compared the physiological impact of maternal carrying behaviors across species. The findings may lead to better parenting techniques for people and possibly to new ways to detect developmental disorders early in life.
-
'Living Fossil' Gets Its Genome Sequenced
The coelacanth isn't called a "living fossil" for nothing. The six-foot-long, nearly 200-pound fish was thought to have gone extinct 70 million years ago — until a fisherman caught one in 1938 — and the animal looks a lot like its fossil ancestors dating back 300 million years. Now, the first analysis of the coelacanth's genome reveals why the fish may have changed so little over the ages. It also may help explain how fish like it moved onto land long ago.
-
Ancient Mating Dance Offers Ranchers, Birds a Lifeline
BURWELL, Neb. — Under an indigo pre-dawn sky, as a frigid wind whipped across the plains, a half-dozen brown-and-white birds emerged from tufts of dry grass. They emitted a low cooing sound, akin to the hooting of an owl.
- More Science/Technology Headlines
-
Toddler is youngest to ever get lab-made windpipe
