Until now, iPS cell research and development has been mainly led by Kyoto University's Center for iPS Cell Research and Application (CiRA) and medical schools at various universities, but now iPS cell use is entering the stage of practical application and private companies, including university start-ups, are queuing up to enter the market. However, no iPS cell research has yet been officially approved by the Ministry of Health, Labour, and Welfare (MHLW), and development is currently proceeding through cooperation between universities and private companies.

On April 1, the Kyoto University Foundation for iPS Cell Research, chaired by Yamanaka Shinya, opened and began operation of a facility, Yanai Facility for my iPS Cell Therapy, for storing iPS cells created from individual cells at Osaka's Nakanoshima Cross, a hub for regenerative medicine. Fast Retailing Co., Ltd. Chairperson and President Yanai Tadashi provided support to establish the facility to the tune of 500 million yen a year for nine years. The facility was established to store iPS cells created from human cells, which are immune compatible with many people and are said to cause virtually no rejection, as well as iPS cells created from one's own cells.

Among private-sector companies, the Pasona Group Inc. is making conspicuous moves. The Group is exhibiting a "moving iPS heart" the size of a thumb produced using cardiac muscle sheets made from iPS cells in the Pasona Nature Berth at the Osaka Expo. Companies other than the Pasona Group are also making progress in commercializing cardiac muscle sheets.

CUORiPS, an Osaka University-based startup, announced on April 8, 2025 that it has applied to MHLW for approval to manufacture and market cardiac muscle sheets made from iPS cells. This is the first application for a product derived from iPS cells for use in patients with severe heart failure. Given the paucity of data, the approval is likely to be tentative.

Kyoto University-based startup iHeart Japan announced on July 28 that it has begun a clinical trial to determine whether a cell product made from iPS cells can be used to treat dilated cardiomyopathy. Myocardial cells and vascular endothelial cells produced from iPS cells are formed into sheets, five sheets of which sandwich layers of gelatin gel, the whole then being attached to the heart of a patient in order to restore heart function. The Tokyo Women's Medical University transplanted the cells into the first patient in May, and other facilities, including the University of Tokyo Hospital, are planning to conduct transplants in ten patients by March of next year. Thus, cardiac sheets are one of the applications of iPS cells at a most advanced stage.

Professor Takahashi Jun of Kyoto University's CiRA and his team reported in the April 16 issue of Nature that they had transplanted nerve cells made from iPS cells into seven patients with Parkinson's disease and confirmed their safety and efficacy (May 2025 BJ). In response, Sumitomo Pharma, which has been promoting the commercialization of the iPS cell-derived Parkinson's disease drug, submitted an application for approval to MHLW on August 5. If approved, it would be the first product made from iPS cells. iPS cells have also been attracting attention in the world of stock prices, with Sumitomo Pharma's stock price soaring following news reports of the Nature article in April.

Further, on March 19, ITOEN announced that it had begun joint research with Kyoto University's CiRA to use iPS cells to create cells that can replace animal testing. ITOEN will investigate whether iPS cells can replace animal testing used to study, among others, the effects of active ingredients in tea. In 2023, ITOEN formulated a policy for research on alternative technologies to replace, and new technologies to minimize, animal testing. In 2024, ITOEN and Kitasato University began testing iPS cells to examine their effects on age-related hearing loss.

Kyoto University startup Shinobi Therapeutics announced on April 11 that it will begin clinical trials at the end of 2026 to treat lung and liver cancer using immune cells (killer T cells) created from iPS cells. The treatment was developed by Professor Arata Kaneko of Kyoto University's CiRA.

Towa Pharmaceutical Co., Ltd. has teamed up with Kyoto University's CiRA to develop a treatment for familial Alzheimer's disease using iPS cells. On June 3, the company announced that it had begun clinical trials on patients. The first phase of clinical trials to assess safety has already been completed, and clinical trials to assess efficacy will now be conducted at medical institutions including those at Mie University and Kyoto University.

Keio University professor Hideyuki Okano and his colleagues have conducted a clinical study in which cells created from iPS cells were transplanted into patients with severe spinal injuries. On March 21, the team announced that they had completed observation on all four patients and confirmed the safety of the treatment. Two patients showed improvement in symptoms, one of whom showed significant improvement. They say they will now aim to conduct clinical trials to rigorously confirm the effects of the trial. The clinical trial is scheduled to be conducted by Keio University startup K Pharma, Inc.

Ajinomoto also announced on June 13 that it has invested in Somite Therapeutics, a US iPS startup. The US company is developing AI technology to optimize cell division. As seen above, while still in the experimental stage, iPS cells have begun to be used as medications. Initial concerns about side effects, such as carcinogenicity, have not been resolved, and the danger exists that rapid commercialization may lead to serious side effects.
(Nikkei Online Edition, 2025/8/5, and others)

The Public-Private Council for Food Technology, established by the Ministry of Agriculture, Forestry and Fisheries, announced on August 18, that it will name food made from cultured cells, currently called cultured meat or cell-cultured meat, cell-based food. Although these foods are produced by culturing cells, the omission of the word culture means that the original meaning of the food is no longer indicated and has been renamed with a misleading name.

On August 6, Kinish Co., Ltd. (located in Shinjuku Ward, Tokyo), a molecular agriculture company that produces milk protein mainly from rice, started selling The Rice Creamery, ice cream that uses milk protein originating from rice. The ice cream is currently available at Tokyu Store's Toritsu-Daigaku store and Seijo Ishii's online shop, but the company plans to increase the number of stores selling the product in the future and is also eyeing sales in the United States. Kinish, a food-tech company established in 2023, developed short-stemmed rice plants of about 20 cm in height, repeatedly cultivating the variety in plant factories to produce casein, a milk protein, from which it has developed high-value-added products. The ice cream is one result of this strategy. Companies developing plant-based casein include Alpine Bio and Mozza Foods in the US and Finally Foods in Israel.
(Foovo 2025/8/8)

It has become apparent that Regional Fish Institute, Ltd., which was farming genome-edited tiger puffer and red sea bream at a land-based aquaculture farm in Miyazu City, Kyoto Prefecture, withdrew from the city at the end of July. In addition, the company stopped providing the red sea bream and tiger puffer as return gifts for Miyazu City's hometown tax payment at the end of May. The land-based aquaculture farm in Miyazu City was located on the site of a Kansai Electric Power Co. oil-fired power plant which was closed in May 2023. Kansai Electric Power plans to improve the site of the aquaculture farm to transform it into an area for attracting companies by fiscal 2028.
(Mainichi Shimbun 2025/8/21)

On August 22, the Ministry of Health, Labour and Welfare (MHLW) and the Ministry of the Environment (MoE) ordered DAP Kita-Aoyama D. CLINIC, a medical corporation based in Shibuya Ward, Tokyo, to take measures based on the Cartagena Law to prevent the spread of genetically engineered organisms. The decision was made in response to the hospital's unapproved use of genetically modified organisms in a medical procedure called CDC6shRNA therapy.