INSTITUTION PROFILE / CELL CULTURE TECHNOLOGY
CiRA Foundation
A public-interest foundation that supplies clinical-grade iPS cells as a raw material in Japan and abroad
The CiRA Foundation is a Japanese public interest incorporated foundation set up by Kyoto University. It is neither a regulator nor a funding agency. Its job is to manufacture, quality-test and store iPS cells fit for use in treatment, and to supply them to research institutions and companies as a raw material. Two iPS cell-derived products that received conditional and time-limited approval in Japan in March 2026, Sumitomo Pharma's Amchepry and Cuorips's Reheart, are presented by the foundation as "products derived from the iPS cell stock". This profile looks at one question only: how much influence the CiRA Foundation actually has over cell culture technology, focusing on the reach of its supply and where that supply goes.
- The CiRA Foundation in 30 seconds
- What kind of body it is: the four types of influence
- What it does in cell culture technology
- How far its influence reaches (powers and geography)
- Companies and organisations involved
- Outlook
- Glossary, references and claim-to-source audit
1. The CiRA Foundation in 30 seconds
The CiRA Foundation's influence travels not through powers but through a raw material. The foundation makes clinical-grade iPS cells from HLA-homozygous donors, checks their quality in advance, freezes them, and supplies them on request to research institutions and companies in Japan and overseas Sourced. It lists Amchepry and Reheart, which received conditional and time-limited approval on 6 March 2026, as "regenerative medicine products derived from the iPS cell stock" Sourced. In other words, a single public-interest foundation provides part of the starting material for approved products. Companies that make their own iPS cells instead of using the foundation's stock, on the other hand, are beyond its reach.
2. What kind of body it is: the four types of influence
Unlike the companies in this series, none of the institutions that appear in cell culture coverage sells products. What separates them is the route by which they influence the industry, and that gives four types. The CiRA Foundation is an unusual institution in that it fits none of them neatly.
3. What it does in cell culture technology
The main things the CiRA Foundation supplies or runs are listed below Sourced. All prices are per vial, excluding tax, and non-profit organisations receive the cells free of charge.
| Service | What it involves | Price for for-profit users | Supplied in FY2025 |
|---|---|---|---|
| HLA homozygous iPS cell stock (clinical grade) | 27 lines made from 7 healthy donors who are homozygous at HLA-A, -B and -DR, covering 4 HLA types that are common in Japan. Used as the starting material for transplanted cells in more than 10 clinical trials | Clinical-grade lines ¥100,000 Master cell bank ¥200,000 | 7 cases (6 lines, 14 vials) |
| HLA genome-edited iPS cell stock | Lines derived from the stock above in which HLA-A, HLA-B and CIITA have been knocked out by genome editing to lower the risk of rejection | ¥200,000 | Clinical grade: 13 cases (3 lines, 25 vials) |
| SeV (Sendai virus) iPS cell stock | Made from the blood of an adult US donor, collected and tested at authorised facilities in the US. Donor eligibility meets Japanese, US and European regulations | ¥100,000 | 6 cases (2 lines, 16 vials) |
| Contract services (manufacturing, quality testing, storage) | Manufacture of differentiated cells at the Facility for iPS Cell Therapy (FiT), quality tests such as genome assessment, and cell storage | Per price list | 44 genome assessment tests, 8 storage contracts |
| my iPS Project | Developing technology to make autologous iPS cells, from the patient's own cells, cheaply in closed automated culture systems. The aim is to supply them at about ¥1 million per patient | In development | The Yanai Facility for my iPS Cell Therapy opened at Nakanoshima, Osaka, in June 2025 |
Use of the stock requires approval from the foundation's iPS Cell Stock Committee. As a rule, clinical-grade lines are supplied at one vial of each line per organisation.
According to the foundation's website, iPS cells are currently made by hand by skilled operators in dedicated facilities, and a single manufacturing line costs tens of millions of yen. Yet the price to for-profit users is ¥100,000 to ¥200,000 per vial, and revenue from the cell supply business in FY2025 was ¥14.36 million. In the same year the foundation received ¥3,383.02 million in donations and ¥1,276.42 million in subsidies from the government and other bodies Sourced. We read the stock as something closer to a public good supported by donations and public money than a product sold as a business Our calculation. The my iPS Project is working on automated culture systems, 3D culture, reagent "kits" and non-destructive, image-based quality testing precisely to bring that manual cost down. For the thinking behind automated culture, see also our explainers on iPS cells and cell culture media.
4. How far its influence reaches (powers and geography)
| Aspect | What the CiRA Foundation has | What it does not have |
|---|---|---|
| Powers | The power to review and approve the use of its own stock (through the iPS Cell Stock Committee, which also covers secondary use by other organisations). The power to set supply prices and conditions | Any power to approve products, regulate or set standards. Approval is granted by the Minister of Health, Labour and Welfare |
| Geography | Supplies research institutions and companies in Japan and abroad, and accepts applications from overseas organisations. Two lines registered in a US FDA Drug Master File (DMF). Takes part in the industry alliance programme of the California Institute for Regenerative Medicine (CIRM) | Influence over companies that do not use its stock, or over other countries' regulations |
| Supply record | As of 31 March 2026: clinical-grade stock supplied to 106 labs at 46 organisations, clinical-grade genome-edited stock to 50 labs at 25 organisations, and research-grade stock to 156 labs at 95 organisations | A breakdown between Japan and overseas has not been published |
| Scale | 149 staff; ordinary revenue of ¥5,159.19 million in FY2025 | Programmes that hand out research funding to other organisations (its articles of incorporation include research grants, but the business report we checked records no such allocations) |
Three pieces of primary information show how far the foundation reaches overseas. The first is its relationship with the FDA: when Sumitomo Pharma was preparing to start clinical trials in the US, the FDA replied on 29 April 2022 that iPS cells derived from the QHJI donor meet the donor eligibility requirements it sets. The second is that in 2024 the foundation registered two lines in an FDA DMF, both from the QHJI donor, who carries the HLA type most common among Japanese people (QHJI01s04 and QHJI14s04). The aim is to simplify the procedure when companies using the cells apply for approval in the US. The third is that the list of studies approved by the foundation's ethics review includes companies and universities outside Japan, such as Vertex Pharmaceuticals, Rutgers University, Odense University Hospital/University of Southern Denmark and iCamuno Biotherapeutics (Suzhou) Sourced.
The HLA homozygous stock is built from HLA types that are common in Japan Sourced. The primary sources we checked say nothing about how well it would avoid rejection in patients who are not Japanese Not yet confirmed. Our reading is that the lines that matter for overseas use are the genome-edited lines, whose HLA has been edited, and the SeV lines, which come from a US donor and meet Japanese, US and European regulations Our calculation. Note also that "46 organisations" is the foundation's own published supply count, and a single organisation may run several studies.
5. Companies and organisations involved
| Organisation or company | Relationship with the CiRA Foundation (as stated in primary sources) | Link to this series |
|---|---|---|
| Sumitomo Pharma | Amchepry (raguneprocel) is listed as a product derived from the foundation's stock. The foundation, as the cell supplier, helped with the company's discussions with the FDA ahead of US clinical trials. The collaborators list places the company under both collaborative research and my iPS Circle | See our Sumitomo Pharma profile |
| Cuorips | Reheart (a cardiomyocyte sheet derived from human allogeneic iPS cells) is listed as a product derived from the foundation's stock. A collaborative research partner | Not covered in this series |
| Ajinomoto and Miltenyi Biotec | Members of my iPS Circle (the my iPS Circle section of the collaborators list shows the logos of 35 organisations) | See our Ajinomoto and Miltenyi Biotec profiles |
| AMED | Provides subsidies through programmes such as the Program for Accelerating the Realisation of Regenerative, Cell and Gene Therapy. The research behind the DMF registration was also supported by AMED | See our profile of AMED |
| PMDA and the Ministry of Health, Labour and Welfare | In FY2025 the foundation held two pre-consultation meetings and one face-to-face consultation with PMDA. The two products were approved on 6 March 2026 | See our profiles of PMDA and the Ministry of Health, Labour and Welfare |
| FDA and CIRM (US) | DMF registered with the FDA (2024). Joined CIRM's Industry Alliance Program as an "Industry Resource Partner" (January 2024) | See our profile of the U.S. Food and Drug Administration |
6. Outlook
| What the evidence suggests | Primary information it rests on | Category |
|---|---|---|
| Having become the raw material for approved products, the foundation's influence will last as long as those products stay on the market | Both products are listed as derived from the foundation's stock, and the FY2026 business plan says the foundation will manufacture the cell banks most in demand and supply them promptly to meet users' requests | Inference |
| Overseas, its influence will spread less through lines matched to Japanese HLA types than through lines built for regulatory use (the DMF-registered, SeV and genome-edited lines) | The DMF registration, the SeV lines that meet Japanese, US and European donor eligibility rules, and the FY2026 plan's aim of a system that is easier to use for users in Japan and abroad | Inference |
| The my iPS Project aims for clinical trials by recipient organisations to start during FY2028 | A target stated on the foundation's my iPS Project page and in its FY2026 business plan | Not yet confirmed |
| The foundation's capacity to supply is sensitive to how much it raises in donations | Donations made up more than 60% of ordinary revenue in FY2025, and the FY2026 plan says it will secure other sources of funding so that the foundation is not run on donations alone | Inference |
7. Glossary
- HLA homozygous
- Describes a person who inherited the same HLA type from both parents. iPS cells made from their cells are less likely to be rejected by the many people who carry that HLA type on at least one chromosome.
- iPS cell stock
- Clinical-grade iPS cells that have been manufactured, quality-tested and frozen in advance. Using them takes far less time and money than making cells for each patient.
- Master cell bank
- A storage unit of cells made by expanding a clinical-grade line, completing quality control testing and dividing it into many vials.
- Drug Master File (DMF)
- A system in which a supplier voluntarily submits detailed information on a raw material or similar item to the US FDA. Companies using that material then only need to reference it in their applications.
- Conditional and time-limited approval
- A Japanese pathway for regenerative medicine products. Approval is granted early with conditions and a time limit, and the company must apply for approval again within that limit.
- Autologous / allogeneic
- Autologous means using the patient's own cells; allogeneic means using another person's cells. The stock is allogeneic; my iPS is autologous.
8. References
- CiRA Foundation Overview and history (in Japanese): name, English name, founder, founding date, move to public interest incorporated foundation status, address, activities, start of stock supply and facility licences. https://www.cira-foundation.or.jp/j/about/overview/
- CiRA Foundation FY2025 business report (in Japanese): 149 staff, composition of funding, numbers of supplies and contract jobs, PMDA consultations, donations and the Nakanoshima facility. https://www.cira-foundation.or.jp/j/assets/file/about/R7_cira-f_business_report.pdf
- CiRA Foundation FY2025 financial statements (in Japanese): ordinary revenue, donations received, subsidies received, breakdown of business revenue and the bodies granting subsidies. https://www.cira-foundation.or.jp/j/assets/file/about/R7_cira-f_financial_statementst.pdf
- CiRA Foundation FY2026 business plan (in Japanese): policy on supplying cell banks, a system for users in Japan and abroad, the my iPS target of entering the clinic in FY2028, and diversifying funding sources. https://www.cira-foundation.or.jp/j/assets/file/about/R8_cira-f_business_plan.pdf
- CiRA Foundation iPS Cell Stock Project (in Japanese): supply to research institutions and companies in Japan and abroad, and FiT's licence numbers. https://www.cira-foundation.or.jp/j/about/project/ips-stock-project/
- CiRA Foundation HLA homozygous iPS cells (in Japanese): 7 donors, 4 HLA types and 27 lines, prices, more than 10 clinical trials, the FDA's reply on donor eligibility, and the DMF registration. https://www.cira-foundation.or.jp/j/provision-of-ips-cells/homozygous/
- CiRA Foundation HLA genome-edited iPS cells (in Japanese): genes knocked out and prices. https://www.cira-foundation.or.jp/j/provision-of-ips-cells/genome-edited/
- CiRA Foundation SeV iPS cells (in Japanese): US donor, Japanese, US and European donor eligibility, and prices. https://www.cira-foundation.or.jp/j/provision-of-ips-cells/sev/
- CiRA Foundation Supply record (in Japanese): numbers of labs and organisations as of 31 March 2026. https://www.cira-foundation.or.jp/j/achievement/
- CiRA Foundation iPS cell supply record (in Japanese): the two approved products derived from the stock, clinical trials using the stock, and the list of studies approved by the ethics review. https://www.cira-foundation.or.jp/j/achievement/provision-of-ips-cells/
- CiRA Foundation FAQ on iPS cell supply (in Japanese): how applications from overseas organisations are handled. https://www.cira-foundation.or.jp/j/faq/provision-of-ips-cells/
- CiRA Foundation News, "Notice of US Drug Master File registration of the clinical-grade iPS cell stock (QHJI lines)" (in Japanese, February 2024). https://www.cira-foundation.or.jp/j/news/2024/02/22-000920.html
- CiRA Foundation News, "Agreement signed with CIRM (US) on the Industry Alliance Program" (in Japanese, January 2024). https://www.cira-foundation.or.jp/j/news/2024/01/18-000332.html
- CiRA Foundation my iPS Project (in Japanese): the cost of manual manufacturing, the target of about ¥1 million per patient, the target of starting clinical trials during FY2028, and work on automation. https://www.cira-foundation.or.jp/j/about/project/myips/
- CiRA Foundation Our collaborators (in Japanese): the collaborative research and my iPS Circle categories. https://www.cira-foundation.or.jp/j/about/team/
- PMDA List of products approved in FY2025 (regenerative medicine products; in Japanese): approval dates and type of approval for Reheart and Amchepry. https://www.pmda.go.jp/files/000280052.pdf
9. Claim-to-source audit
| Claim in the article | Category | Source |
|---|---|---|
| Official name, abbreviation and English name, founder, founding date, move to public interest incorporated foundation status, address, start of stock supply (August 2015) | Sourced | Reference 1 https://www.cira-foundation.or.jp/j/about/overview/ |
| 149 staff (including 6 on secondment and 40 agency staff); FY2025 numbers of supplies, contract jobs and PMDA consultations; opening of the Nakanoshima facility | Sourced | Reference 2 https://www.cira-foundation.or.jp/j/assets/file/about/R7_cira-f_business_report.pdf |
| Ordinary revenue of ¥5,159.19 million, donations of ¥3,383.02 million, subsidies of ¥1,276.42 million, business revenue of ¥284.08 million, cell supply revenue of ¥14.36 million, AMED subsidies | Sourced | Reference 3 https://www.cira-foundation.or.jp/j/assets/file/about/R7_cira-f_financial_statementst.pdf |
| Donations make up more than 60% of ordinary revenue | Our calculation | Donations received divided by total ordinary revenue in reference 3 (our calculation) |
| FY2026 policy on supplying cell banks, a system for users in Japan and abroad, diversifying funding sources | Sourced | Reference 4 https://www.cira-foundation.or.jp/j/assets/file/about/R8_cira-f_business_plan.pdf |
| Supply on request to research institutions and companies in Japan and abroad | Sourced | Reference 5 https://www.cira-foundation.or.jp/j/about/project/ips-stock-project/ |
| 7 donors, 4 HLA types and 27 lines; prices; more than 10 clinical trials; the FDA's reply on donor eligibility (29 April 2022) | Sourced | Reference 6 https://www.cira-foundation.or.jp/j/provision-of-ips-cells/homozygous/ |
| Genes knocked out in the genome-edited lines, and their price | Sourced | Reference 7 https://www.cira-foundation.or.jp/j/provision-of-ips-cells/genome-edited/ |
| The SeV lines' US donor, Japanese, US and European donor eligibility, and price | Sourced | Reference 8 https://www.cira-foundation.or.jp/j/provision-of-ips-cells/sev/ |
| Numbers of labs and organisations supplied (as of 31 March 2026) | Sourced | Reference 9 https://www.cira-foundation.or.jp/j/achievement/ |
| The two approved products derived from the stock, the companies running trials, and the list of studies including overseas companies and universities | Sourced | Reference 10 https://www.cira-foundation.or.jp/j/achievement/provision-of-ips-cells/ |
| Handling of applications from overseas organisations | Sourced | Reference 11 https://www.cira-foundation.or.jp/j/faq/provision-of-ips-cells/ |
| DMF registration of the two QHJI lines and its purpose; AMED support | Sourced | Reference 12 https://www.cira-foundation.or.jp/j/news/2024/02/22-000920.html |
| Participation in CIRM's industry alliance programme | Sourced | Reference 13 https://www.cira-foundation.or.jp/j/news/2024/01/18-000332.html |
| Manual manufacturing costing tens of millions of yen; targets of about ¥1 million per patient and clinical trials starting during FY2028 | Sourced | Reference 14 https://www.cira-foundation.or.jp/j/about/project/myips/ |
| Collaboration categories for Sumitomo Pharma, Cuorips, Ajinomoto and Miltenyi Biotec; the 35 organisations in my iPS Circle | Sourced | Reference 15 https://www.cira-foundation.or.jp/j/about/team/ |
| Approval date of Reheart and Amchepry (6 March 2026) and their conditional and time-limited approval | Sourced | Reference 16 https://www.pmda.go.jp/files/000280052.pdf |
| The four types of institution, the judgement that convening is the closest type, and the layout of Fig. 2 | Our calculation | Our own classification |
| The reading that the genome-edited and SeV lines are the ones that matter overseas | Our calculation | This article's reading of references 6 to 8 |
| How well rejection is avoided in patients who are not Japanese; the split of recipients between Japan and overseas | Not yet confirmed | Not stated in references 6 or 9; this article does not estimate them |
| The outlook in section 6 (three inferences; the one foundation target is marked Not yet confirmed) | Inference | This article's reading of references 3, 4, 6 to 8, 10, 12 and 14 |
Last updated 24 September 2026 / Troy Technical
This article is based on the CiRA Foundation's official website, its business report, financial statements and business plan, and PMDA's list of approved products. Items marked "Inference" are this article's reading of the primary information, not statements by the CiRA Foundation.