A Kyoto-based medical startup said Monday it has developed what it believes to be the world’s first method for mass-producing blood platelets from induced pluripotent stem cells, better known as iPS cells, opening new possibilities for controlling bleeding after accidents or surgeries.
Platelets are used to minimize bleeding and are made from donated blood.
Megakaryon Corp. teamed up with a group of 15 other Japanese companies for the iPS cell project, including the Otsuka Pharmaceutical group and Sysmex Corp., to develop a cheaper method to mass produce platelets.
Genjiro Miwa, CEO and founder of Megakaryon, said the consortium plans to get approval to sell and distribute the product in Japan and the United States by 2020 and hopes to expand its use in other nations. Clinical trials in Japan and the U.S. are expected to begin next year.
Shinya Yamanaka of Kyoto University received the Nobel Prize in Physiology or Medicine in 2012 for creating iPS cells, which can develop into any type of cell in the body. These cells hold great promise in the field of regenerative medicine and drug development.
Speaking to The Japan Times, Miwa said that around 800,000 platelet transfusions take place annually in Japan, generating a market worth around ¥73 billion. He said the market is around three times that size in the U.S. Once the new technology gets the green light, the consortium hopes to produce iPS-derived platelets to meet roughly 10 percent of that annual requirement, Miwa said.
The company said Japan’s aging population and low birth rate have raised concerns about the long-term supply of platelets provided through donations alone.
“Our aim is to fill the expected shortage of platelets,” Miwa said.
Platelets play an important role in the blood-clotting process. While donated platelets have a shelf life of only four days, Megakaryon says those made from iPS cells can be stored for two weeks. It says the technology will also lead to cheaper production of platelets.
The new technology is based on techniques developed by Professor Hiromitsu Nakauchi of the University of Tokyo, and Professor Koji Eto of Kyoto University.
Megakaryon, founded in 2011, obtained the exclusive rights to use the patents on the technologies and has been conducting research to enable mass production of platelets.
Miwa said his company is already capable of producing enough platelets to help several patients each week, but that he hopes to boost output by a factor of 1,000 through partnerships with major pharmaceutical firms and other companies.
Other members of the consortium include Satake Chemical Equipment Manufacturing, Nissan Chemical Industries, Kawasumi Laboratories and Kyoto Seisakusho.
Last week, Kyoto University said its researchers are set to begin the world’s first clinical trial of a drug to treat a rare bone disease called fibrodysplasia ossificans progressiva (FOP) — a disorder in which muscle tissue is gradually replaced by bone, inhibiting body movement. The drug’s effectiveness was confirmed in conjunction with the use of iPS cells.