INSTITUTION PROFILE / iPS CELLS & REGENERATIVE MEDICINE
ISSCR (International Society for Stem Cell Research)
The international society that sets the yardstick for iPS cells and regenerative medicine
ISSCR is an international society of stem cell researchers, headquartered in the United States. It is not a government body, and it neither approves products nor regulates them in law. Instead, it writes guidelines, brings researchers together at an annual meeting and talks with regulators in many countries, and that has made it a yardstick that institutions and regulators around the world refer to. This profile asks how much influence ISSCR really has over iPS cells and regenerative medicine, keeping in view the difference between being referred to and being obeyed.
What this article covers
- ISSCR in 30 seconds
- What kind of body it is: the four types of influence
- What it does for iPS cells and regenerative medicine
- How far its influence reaches (powers and geography)
- Who else is involved: where its guidance lands
- Outlook
- Glossary, references and claim-to-source audit
1. ISSCR in 30 seconds
LEGAL NAMEInternational Society for Stem Cell ResearchUsually shortened to ISSCR
COUNTRY / REGIONInternational (headquartered in the United States)Headquarters in Evanston, Illinois. Members in more than 80 countries
TYPE OF BODYLearned societyNot a government body. It also publishes the journal Stem Cell Reports
ESTABLISHEDMore than 20 years agoWe have not confirmed the exact year. The first edition of its guidelines came out in 2006
SIZEMore than 80 countriesWe did not find a published membership figure within the sources checked. More than 150 volunteers
SCALE INDICATORAnnual meeting of about 3,000 peopleThe 2026 meeting in Montreal. We have not confirmed its budget
ROLE IN iPS CELLS & REGENERATIVE MEDICINEGuidelines and standardsGuidelines for research and clinical translation, and guidance on pluripotent stem cell-derived therapies
REACHAn international reference pointNot legally binding; national law takes precedence
The one thing to grasp first
ISSCR's influence is the power to be referred to, not the power to compel. The guidelines themselves state that they do not override national laws or regulations Sourced. Its influence is nonetheless considerable, according to ISSCR, because the UK's 2024 code of practice for stem cell-based embryo models builds on the ISSCR guidelines, and because the U.S. National Academies has said the guidelines are widely followed by research institutions Sourced. Both claims are ISSCR's own. It has no powers comparable to those of the Minister of Health, Labour and Welfare in Japan, who decides approvals, or of the U.S. Food and Drug Administration (FDA).
2. What kind of body it is: the four types of influence
Unlike the companies in this series, the institutions that appear in iPS cell and regenerative medicine coverage do not sell products. What separates them is the route by which they influence the industry, and that gives four types.
3. What it does for iPS cells and regenerative medicine
| Activity | What it covers | Category |
|---|---|---|
| Guidelines | The Guidelines for Stem Cell Research and Clinical Translation. The 2021 edition was fully revised, and in August 2025 only the section on stem cell-based embryo models was updated (v1.2). The guidelines have five chapters: ethical principles, embryo research and related areas, clinical translation, communication, and standards for research | Sourced |
| Position on unproven treatments | Cells that have been substantially processed, among other products, should be shown to be safe and effective before they are sold to patients (Recommendation 3.1.1). Clinical use of unproven stem cell treatments should be limited to regulated clinical trials and similar settings (Recommendation 3.5.1). The guidelines call for particular scrutiny of trials that charge participants a fee | Sourced |
| Standards for laboratories | Minimum standards for characterising and reporting on human stem cells, for laboratories that use them (available in English, with a Japanese-language PDF as well) | Sourced |
| Guidance on pluripotent stem cell-derived therapies | A roadmap, published in 2025, covering everything from choosing a cell line to manufacturing the product, with regulatory information and timelines for nine jurisdictions. It is aimed at industry, academia and regulators | Sourced |
| Annual meeting and symposia | About 3,000 people attended the 2026 meeting in Montreal. In October 2026 it is holding the "iPSC 20th Anniversary Symposium" in Kyoto (sold out) | Sourced |
| Dialogue with regulators | It says it meets formally with the UK's MHRA, the European Medicines Agency (EMA), Japan's PMDA and Korea's MFDS, and has submitted comments to the FDA and to regulators in India and China (ISSCR's own account) | Sourced |
| Information for patients and the public | Publishes materials and free courses on telling unproven treatments from real science (these do not recommend any particular treatment) | Sourced |
4. How far its influence reaches (powers and geography)
| Aspect | What ISSCR has | What it does not have |
|---|---|---|
| Powers | The power to write and publish guidelines and standards, and to submit comments to regulators | Powers of approval or authorisation, or to change any country's law. The guidelines do not override local law |
| Geography | International. Members in more than 80 countries. National frameworks and university policies refer to it | Any means of compelling a particular country. Whether to refer to it is for each country or institution to decide |
| Binding force | A de facto standard, which arises when members and research institutions follow it voluntarily | Penalties for breaches, or steering through the allocation of funds (neither found within the sources checked) |
| Scale | An annual meeting of about 3,000 people, and more than 150 volunteers | Published membership and budget figures (not found for this article) |
A note on reading the numbers and the praise
Most of the claims that ISSCR is "widely referred to around the world" are written on ISSCR's own official pages. The National Academies comment and the UK code of practice, both cited as third-party recognition, were checked only through ISSCR's account of them; we did not check the original documents Not yet confirmed. We found no membership or financial figures on the official pages we checked.
5. Who else is involved: where its guidance lands
ISSCR's ties with Japan are also visible on its official pages. Past presidents include Shinya Yamanaka (2012 to 2013) and Hideyuki Okano (listed as a past president in the officers' table) Sourced, and Yamanaka and others will give keynote talks at the commemorative symposium in Kyoto in October 2026 Sourced. The ISSCR laboratory standards also exist as a Japanese-language PDF Sourced. These are examples of exchange and outreach. They do not mean that ISSCR has any authority over Japan's approval system or its research funding.
6. Outlook
| What the evidence suggests | Primary information it rests on | Category |
|---|---|---|
| The "iPSC 20th Anniversary Symposium" will be held in Kyoto from 19 to 22 October 2026 (sold out, with no registration on the day) | The event page gives the dates and venue, and says it is sold out | Not yet confirmed |
| As pluripotent stem cell-derived therapies move closer to the clinic, practical documents on manufacturing and regulatory compliance (the guidance and its nine-jurisdiction summary) will carry more weight | The 2025 roadmap, and the president's message, which mentions the conditional approval of an iPS cell-derived product in Japan and several late-stage clinical trials | Inference |
| Its emphasis will widen to setting standards for new approach methodologies (NAMs), which use stem cell-derived disease models in drug discovery | "Disease models and drug discovery" is one of ISSCR's four pillars, and it says it brings together academia, industry and regulators to develop standards | Inference |
7. Glossary
- ISSCR
- The International Society for Stem Cell Research, an international society of stem cell researchers that publishes guidelines and standards.
- Guidelines
- ISSCR's guidance on research and clinical translation. It is not law, and it does not override national law.
- Stem cell-based embryo model
- A structure made from stem cells that resembles an early embryo. The relevant section of the guidelines was updated in 2025.
- Pluripotent stem cells (PSCs)
- A collective term for ES cells and iPS cells, which can turn into many kinds of cell.
- NAMs
- New approach methodologies: test methods that replace or supplement animal experiments.
- Unproven stem cell treatment
- A stem cell treatment offered to patients without approval from a regulator.
8. References
- ISSCR Our Impact: more than 80 countries, regular meetings with regulators, examples of the guidelines being referred to, responses to unproven treatments, and the 2025 roadmap for pluripotent stem cell-derived therapies. https://www.isscr.org/impact
- ISSCR Guidelines for Stem Cell Research and Clinical Translation: the 2021 edition, the update v1.2 of August 2025, and the five chapters. https://www.isscr.org/resources/guidelines-for-stem-cell-research
- ISSCR Guidelines online, "Fundamental Ethical Principles": the statement that the guidelines do not override national laws. https://www.isscr.org/guidelines-online/fundamental-ethical-principles
- ISSCR Guidelines online, "Clinical Translation of Stem Cell-based Interventions": Recommendations 3.1.1 and 3.5.1, and the caution on trials that charge participants. https://www.isscr.org/guidelines-online/clinical-translation-of-stem-cell-based-interventions
- ISSCR Standards for Human Stem Cell Use in Research: minimum characterisation and reporting standards for laboratories, in English, Japanese and other languages. https://www.isscr.org/resources/standards
- ISSCR Best Practices for the Development of Pluripotent Stem Cell-Derived Therapies: guidance for industry, academia and regulators. https://www.isscr.org/resources/translational-best-practices
- ISSCR iPSC 20th Anniversary Symposium: 19 to 22 October 2026, Kyoto International Conference Hall. Sold out. https://www.isscr.org/upcoming-events/2026-kyoto-international-symposium
- ISSCR The Archives: the ISSCR 2026 annual meeting in Montreal, with about 3,000 attendees. The 2025 meeting was in Hong Kong. https://www.isscr.org/the-archives
- ISSCR Our People: officers, with Lorenz Studer as president, and Shinya Yamanaka and Hideyuki Okano among past presidents. https://www.isscr.org/people
- ISSCR President's message: more than 150 volunteers, the secretariat, and the priorities of clinical translation and new approach methodologies. https://www.isscr.org/isscr-news/advancing-discovery-translation-and-global-collaboration
- ISSCR FAQ & Resources: the headquarters location, Evanston, Illinois. https://www.isscr.org/faq
- ISSCR About Stem Cells: an information site for patients and the public, with free courses. https://www.aboutstemcells.org/
9. Claim-to-source audit
| Claim in the article | Category | Source |
|---|---|---|
| More than 80 countries, meetings with regulators (MHRA, EMA, PMDA, MFDS), examples of the guidelines being referred to, and the 2025 roadmap (nine jurisdictions) | Sourced | ISSCR's own account / Reference 1 https://www.isscr.org/impact |
| The 2021 edition of the guidelines, the update of August 2025 (the embryo-model section), and the five chapters | Sourced | Reference 2 https://www.isscr.org/resources/guidelines-for-stem-cell-research |
| The guidelines do not override national laws | Sourced | Reference 3 https://www.isscr.org/guidelines-online/fundamental-ethical-principles |
| Recommendations 3.1.1 and 3.5.1, and the caution on trials that charge participants | Sourced | Reference 4 https://www.isscr.org/guidelines-online/clinical-translation-of-stem-cell-based-interventions |
| Standards for laboratories (including the Japanese-language PDF) | Sourced | Reference 5 https://www.isscr.org/resources/standards |
| Guidance on pluripotent stem cell-derived therapies | Sourced | Reference 6 https://www.isscr.org/resources/translational-best-practices |
| The dates, sell-out and keynote speakers of the October 2026 Kyoto symposium | Sourced | Reference 7 https://www.isscr.org/upcoming-events/2026-kyoto-international-symposium |
| The venue and attendance (about 3,000) of the 2026 annual meeting | Sourced | Reference 8 https://www.isscr.org/the-archives |
| The president and past presidents (Shinya Yamanaka, Hideyuki Okano) | Sourced | Reference 9 https://www.isscr.org/people |
| More than 150 volunteers, the secretariat, and the president's priorities (clinical translation, NAMs, international collaboration) | Sourced | Reference 10 https://www.isscr.org/isscr-news/advancing-discovery-translation-and-global-collaboration |
| The headquarters location | Sourced | Reference 11 https://www.isscr.org/faq |
| The information site and courses for patients and the public | Sourced | Reference 12 https://www.aboutstemcells.org/ |
| The four types of institution, and the groupings in Fig. 2 | Our calculation | Our own classification in this article |
| Membership, budget, year of establishment, and checking the original documents behind the third-party recognition | Not yet confirmed | Not stated in references 1 to 12; this article does not estimate them |
| The two inferences in the outlook (section 6) | Inference | This article's reading of references 1, 6 and 10 |
Last updated 1 October 2026 / Troy Technical
All figures come from ISSCR's official website. Much of the praise cited is ISSCR's own account of itself. Items marked "Inference" are this article's reading of the primary information, not statements by ISSCR.