The ISSCR guidelines are the International Society for Stem Cell Research’s guidelines for stem cell research and clinical translation, a set of ethical and scientific standards for laboratory work, human studies and patient-facing stem cell interventions.
They are a reference point for researchers, journals, funders and regulators working in stem cell research, and they apply alongside national law rather than in place of it.
What the guidelines are and what they cover
The ISSCR says its guidelines address the international diversity of cultural, political, legal and ethical issues associated with stem cell research and its translation to medicine. They maintain and underscore widely shared principles in science that call for rigor, oversight and transparency in all areas of practice.
The society states that adherence to these principles provides assurance that stem cell research is conducted with scientific and ethical integrity and that new therapies are evidence-based. The document is organised into sections on fundamental ethical principles, laboratory-based embryonic stem cell and embryo research, clinical translation of stem cell-based interventions, communications, and standards in stem cell research.
The ISSCR notes that the guidelines were originally updated in 2021 to cover a broader scope of research and clinical activity, including recommendations on embryos, stem cell-based embryo models, chimeras, organoids and genome editing. In 2025 a targeted update changed only the sections on stem cell-based embryo models, and all other sections remain as published in 2021.
Their legal standing
The guidelines are professional standards, not statutes. According to the ISSCR’s text, they do not supersede local laws and regulations. They complement existing legal frameworks and can inform the interpretation and development of laws, and they provide guidance for research practices that legislation does not cover.
That is why they sit beside regulators’ rules rather than replacing them. How a national regulator treats cell-based products is covered in FDA regulation of cell therapy.
Taken together, the update history shows that the document is revised in response to science rather than fixed once. The ISSCR describes the 2025 change as a focused approach that let it respond to a defined scientific and oversight need and to offer updated international guidance for researchers, journal editors, regulators, funders and the public. That audience list is a useful reminder that the guidelines are written for people who make decisions about research, not only for scientists at the bench.
Core ethical principles
The ISSCR text lists several principles. On the integrity of the research enterprise, it says the primary goals of stem cell research are to advance scientific understanding, to generate evidence for addressing unmet medical and public health needs, and to develop safe and efficacious therapies for patients. It names independent peer review and oversight, replication, institutional oversight and accountability at each stage as key processes.
On patient and participant welfare, the guidelines say physicians and physician-researchers owe their primary duty of care to patients and research subjects, and that clinical testing should never allow promise for future patients to override the welfare of current research subjects.
The guidelines also name the features that make stem cell work distinctive, including sensitivities around research using human embryos and gametes, irreversible risks associated with some cell-based interventions such as those involving genome editing, and the vulnerability and pressing medical needs of patients with serious conditions that currently lack effective treatments.
Clinical translation and unproven interventions
The guidelines draw a firm line between research and marketing. The ISSCR states that the application of stem cell-based interventions outside formal research settings should occur after products have been authorized by regulators and proven safe and efficacious, include long-term patient follow-up and adverse event reporting, and serve patients’ best interests. It calls it a breach of professional medical ethics and responsible scientific practice to market or provide stem cell-based interventions before rigorous and independent expert review of safety and efficacy and appropriate regulatory approval.
The clinical translation section adds that the ISSCR condemns the administration of unproven stem cell and other cell and tissue-based interventions outside of clinical research or medical innovation that complies with the guidelines, particularly when it is performed as a business activity.
On payment, the guidelines state as a general rule that study participants should not be charged to access investigational products or to participate in clinical studies, and that exceptions should be subject to close scrutiny by bodies such as institutional review boards and national regulators.
Trial registration and transparency
The same section recommends that all trials be prospectively registered in public databases. It explains that registration offers transparency regarding promising stem cell-based interventions so that patients, regulators and the scientific community can monitor these efforts. Readers who want to look up registered studies can follow the steps in the guide to stem cell clinical trials.
On early-phase studies, the guidelines note that they provide the first opportunity to evaluate promising interventions in humans and also the first occasion where humans are exposed to an unproven intervention. They say all preclinical study results, including negative and neutral studies, should be considered before first-in-human trials begin.
In practice, the guidelines give readers a checklist for judging news and advertising. Is the intervention being given inside a registered trial or after regulatory authorization? Is there long-term follow-up and adverse event reporting? Are participants being asked to pay? Each question maps to a specific statement above, and none of them depends on how promising an intervention is said to be.
The guidelines also acknowledge that regulators and funders need confidence in the evidence they rely on. The ISSCR text says physicians and payers need to be confident that the evidence they use to make important healthcare decisions is rigorous and unbiased, and that patients should be able to enroll in clinical research trusting that studies are well justified, appropriately designed and ethically sound.
Resources for patients and the public
The ISSCR also publishes a patient-facing site, which describes a stem cell treatment as one that uses stem cells or the specialized cell types that come from stem cells to replace or repair a patient’s cells or tissues that are damaged or absent. Its resources are intended for patients and for their physicians to use when making decisions.
Decisions about any specific treatment or trial belong with a licensed physician who knows the person’s situation, and the guidelines themselves are written for researchers and clinicians rather than as advice to individuals.
Frequently asked questions
Are the ISSCR guidelines legally binding?
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No. The guidelines state that they do not supersede local laws and regulations, though they complement legal frameworks and can inform how laws are interpreted and developed.
What changed in the most recent update?
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The latest targeted update revised only the sections on stem cell-based embryo models. All other sections remain as published in the earlier full update.
What do the guidelines say about unproven treatments?
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They condemn giving unproven stem cell interventions outside of compliant clinical research or medical innovation, particularly as a business activity.
Should trial participants be charged?
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As a general rule, no. The guidelines say participants should not be charged to access investigational products or to take part in clinical studies, with exceptions closely scrutinised.
