{"id":73441,"date":"2026-08-13T09:14:08","date_gmt":"2026-08-13T09:14:08","guid":{"rendered":"https:\/\/www.europesays.com\/japan\/73441\/"},"modified":"2026-08-13T09:14:08","modified_gmt":"2026-08-13T09:14:08","slug":"editorial-can-ips-cells-clear-the-barriers-to-practical-use","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/japan\/73441\/","title":{"rendered":"Editorial: Can iPS cells clear the barriers to practical use?"},"content":{"rendered":"

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\nAn induced pluripotent stem (iPS) cell is shown in this photo. (Photo courtesy of Kyoto University professor Shinya Yamanaka) <\/p>\n


\n It has been 20 years since induced pluripotent stem (iPS) cells, which were expected to transform regenerative medicine, first appeared. The technology is now at a critical turning point: Will it become widely available as a means of helping people suffering from disease? \n<\/p>\n


\n On Aug. 11, 2006, Kyoto University professor Shinya Yamanaka announced that he had succeeded in creating iPS cells from mouse skin cells. These cells can develop into various tissues and organs. In 2012, he was awarded the Nobel Prize in physiology or medicine. \n<\/p>\n


\n The fruits of that research were finally made available to many patients this March. Two products derived from iPS cells received approval from the Japanese government for the first time: “Amchepri,” for the treatment of Parkinson’s disease, and “RiHEART” for heart disease. \n<\/p>\n


\n There is no doubt that government support for this homegrown Japanese technology has helped drive its practical use. Since 2013, the government has invested roughly 110 billion yen (about $690 million) in research funding over a decade and created a new policy aimed at accelerating practical applications. \n<\/p>\n


\n It established “conditional and time-limited approval,” under which the government can approve the manufacture and sale of regenerative medicine products even when based on relatively small clinical trials that would not normally suffice for approval. However, the two approved products are, for now, at the “provisional license” stage. Attention will now turn to the treatment data they generate. \n<\/p>\n


\n One major challenge is the difficulty of product development. As regenerative medicine relies on living cells, distribution and management require considerable effort. Manufacturers must also establish systems capable of producing products of the required quality consistently. Takeda Pharmaceutical Co. and Kyoto University’s Center for iPS Cell Research and Application had been engaged in industry-academia joint research since fiscal 2015, but that collaboration ended this year without producing a new product. \n<\/p>\n


\n The “side effects” of policies designed to promote regenerative medicine also cannot be overlooked. \n<\/p>\n


\n In 2014, the government enacted the Act on the Safety of Regenerative Medicine, which established rules for conducting such treatments. Medical institutions can provide regenerative medicine treatment by creating treatment plans, undergoing a review by an expert committee and notifying the Ministry of Health, Labor and Welfare. \n<\/p>\n

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\nA research building at Kyoto University’s Center for iPS Cell Research and Application is seen in this photo taken in Kyoto’s Sakyo Ward in January 2016. With government support, it became one of the research hubs established across Japan to promote regenerative medicine. (Mainichi\/Tetsuro Hatakeyama) <\/p>\n


\n To date, 6,770 notifications have been submitted. However, most involve treatments offered as uninsured, self-paid medical services, while only a small number aim to obtain approval as pharmaceutical products. Many treatments are for cosmetic purposes such as wrinkle removal and make claims with limited scientific evidence, including those for pain relief or diabetes treatment. \n<\/p>\n


\n Concerns about safety have also arisen. Since last summer, the deaths of two patients who received regenerative medicine for chronic pain have been reported. In another case, two patients developed serious infections from a treatment claiming to prevent cancer. Such incidents could damage the credibility of the entire field of regenerative medicine. \n<\/p>\n


\n A fundamental revision of the current law is essential so patients can receive treatment without worrying. At present, in some cases, preapproval reviews fail to adequately assess the validity of proposed treatments. The health ministry is considering frameworks to evaluate the appropriateness of treatments, ways to provide information to patients and improvements to the quality of expert review committees. \n<\/p>\n


\n Even so, expectations remain high for a technology once regarded as a “dream treatment.” \n<\/p>\n


\n After Yamanaka succeeded in creating iPS cells from human skin cells in 2007, many patients began sending him emails hoping for practical medical applications. At the time, he remarked, “I feel a great responsibility to make this a reality.” \n<\/p>\n


\n The question now is whether this research, which opened a new frontier in biology, can overcome its challenges and bear fruit. <\/p>\n","protected":false},"excerpt":{"rendered":" An induced pluripotent stem (iPS) cell is shown in this…\n","protected":false},"author":2,"featured_media":73442,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5],"tags":[436,8,151,186,2737,437,187],"class_list":["post-73441","post","type-post","status-publish","format-standard","has-post-thumbnail","category-kyoto","tag-editorial","tag-japan","tag-kyoto","tag-latest-articles","tag-medical","tag-opinion-analysis","tag-the-mainichi"],"_links":{"self":[{"href":"https:\/\/www.europesays.com\/japan\/wp-json\/wp\/v2\/posts\/73441","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/japan\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/japan\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/japan\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/japan\/wp-json\/wp\/v2\/comments?post=73441"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/japan\/wp-json\/wp\/v2\/posts\/73441\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/japan\/wp-json\/wp\/v2\/media\/73442"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/japan\/wp-json\/wp\/v2\/media?parent=73441"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/japan\/wp-json\/wp\/v2\/categories?post=73441"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/japan\/wp-json\/wp\/v2\/tags?post=73441"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}