NIH Stem Cell Information

NIH Guidelines for Human Stem Cell Research FAQs

Submitting a New Cell Line

Per NOT-OD-26-031, NIH is pausing review and approval of applications for new human embryonic stem cell (hESC) lines to be added to the NIH Human Embryonic Stem Cell Registry (Registry). Previously approved hESC lines listed on the Registry may continue to be used in NIH-funded research.

Cell Line Availability
NIH Guidelines for Human Stem Cell Research
NIH GPS Section 4.2.4
Other Policy Questions
Submitting a New Cell Line

Per NOT-OD-26-031, NIH is pausing review and approval of applications for new human embryonic stem cell (hESC) lines to be added to the NIH Human Embryonic Stem Cell Registry (Registry). Previously approved hESC lines listed on the Registry may continue to be used in NIH-funded research.

Cell Line Availability
I am a scientist funded by the NIH. How many cell lines are available to me, and how do I get them?

The NIH has developed the NIH Human Embryonic Stem Cell Registry. This Registry lists all cell lines that are eligible for use in NIH-funded research.

To obtain these cells, please follow the "see details" link, which is found under the Cell Line name, within the NIH Human Embryonic Stem Cell Registry. This link includes more information about the selected cell line, as provided to the NIH. Some of this information may include: whether or not the cell line is available for distribution, the provider's name, telephone number, email address, and URL.

Who owns the cells?

The stem cell lines remain the property of the individual stem cell providers, as listed on the NIH Human Embryonic Stem Cell Registry. Researchers may negotiate a material transfer agreement (MTA) with the cell providers in order to specify their rights and responsibilities concerning resulting data, publications, and potential patents.

NIH Guidelines for Human Stem Cell Research
What types of stem cell research are governed by the NIH Guidelines for Human Stem Cell Research?

Section I of the NIH Guidelines for Human Stem Cell Research (Guidelines) states that “These Guidelines apply to the expenditure of National Institutes of Health (NIH) funds for research using human embryonic stem cells (hESCs) and certain uses of induced pluripotent stem cells.”

Sections II and III apply specifically to human embryonic stem cells (hESCs).

Section II details the eligibility criteria used by the NIH to determine if specific hESC lines are eligible for use in NIH-funded research.

Section III explains the responsibility of the NIH funding recipients to assure that hESCs used in NIH-funded research are approved by NIH.

Section IV details types of human pluripotent stem cell research that are not eligible for NIH funding, even when using hESCs that meet the Section II eligibility criteria. Section IV pertains to “hESCs and human induced pluripotent stem cells, i.e., human cells that are capable of dividing without differentiating for a prolonged period in culture, and are known to develop into cells and tissues of the three primary germ layers.” The prohibitions detailed in Section IV apply to all types of human pluripotent stem cells, including, but not limited to, those developed by methods such as the expression of genes involved in establishing pluripotency (e.g., the “Yamanaka factors”) and the culturing of embryonic germ cells from primordial germ cells.

Section V details other types of research not eligible for NIH funding: the derivation of stem cells from human embryos and research using hESCs derived from sources other than human embryos created using in vitro fertilization for reproductive purposes.

Are there any restrictions on the use of lines listed on the NIH Human Embryonic Stem Cell Registry?

The "see details" link on the NIH Human Embryonic Stem Cell Registry includes information on two categories of possible use restrictions: Provider Restrictions and NIH Restrictions. Provider Restrictions include things such as experiments that are prohibited with the cell line, or requirements that proposed research be approved by an Embryonic Stem Cell Research Oversight (ESCRO) committee or other type of ethical review committee. NIH Restrictions are imposed on the use of a line based on the usage of the cells as agreed to by the donors in their informed consent process. Furthermore, other cell lines derived from a restricted hESC line are subject to the same restriction.

Once a human embryonic stem cell line is listed on the NIH Human Embryonic Stem Cell Registry, are lines derived from it also eligible?

The NIH Guidelines on Human Stem Cell Research focus on the requirements for donation of the embryo that was used for derivation. Once that determination has been made for a particular line, it applies to all subclones or modifications. For example, now that WA01 (H1) is eligible for NIH funding, WA01 lines that express GFP are also eligible.

Should scientists list the name of the subclone in their NIH grant application?

Yes, scientists should refer to the parent hESC line and list the cell line name of the modified line or subclone in the research plan of their application.

Can a scientist use federal funds to conduct research using derivatives of human embryonic stem cell lines that are not listed on the NIH Human Embryonic Stem Cell Registry?

No federal funds may be used, either by a grant recipient or a sub-recipient, to support research using derivatives of human embryonic stem cell lines (hESCs) that are not listed on the NIH Human Embryonic Stem Cell Registry, with the exception described below. Derivatives include, but are not limited to, subclones of hESC lines, modified hESC lines (such as a line expressing green fluorescent protein), differentiated cells developed from hESC lines (such as muscle progenitor cells), and cellular materials (such as DNA, RNA, and proteins). Thus, no federal funds may be used for the generation of new data from unapproved hESC lines or derivatives. However, publicly accessible data from unapproved lines or derivatives may be used and analyzed with federal funds.

Can genomic data generated from human embryonic stem cells (hESCs) not listed in the NIH Human Embryonic Stem Cell Registry be submitted to an NIH-designated data repository (e.g., database of Genotypes and Phenotypes (dbGaP)) under the Genomic Data Sharing (GDS) Policy?

No, genomic data generated from hESCs that are not listed on the NIH Human Embryonic Stem Cell Registry will not be accepted by NIH-designated data repositories such as dbGaP.

Does the NIH require that hESC lines on the NIH Human Embryonic Stem Cell Registry meet the FDA 'Donor Eligibility Rule' (21 CFR 1271 Part C) requirements?

No. The NIH does not require that lines listed on the Registry meet the FDA requirements of 21 CFR 1271 Part C. To be listed on the NIH Human Embryonic Stem Cell Registry, lines must meet the NIH Guidelines for Human Stem Cell Research, which focus on ethical requirements pertaining to the embryo donation process. Thus, the embryo donor screening and testing requirements for relevant communicable diseases agents or diseases in 21 CFR 1271 Part C are not incorporated in the NIH Guidelines. Researchers interested in developing a clinical product, which would be regulated by the FDA, should contact the FDA for more information, ideally prior to donation of the embryo.

Are the documents related to the hESC lines listed on NIH hESC Registry available to the public?

The institutions that own hESC lines submit information to NIH that is pertinent to the requirements in the Guidelines. The public can contact these institutions directly to request the documents. Contact information for the institutions can be found on the NIH Human Embryonic Stem Cell Registry list at https://grants.nih.gov/stem_cells/registry/current.htm (click on “see details” for each cell line).

Documents reviewed by NIH staff can also be requested per Freedom of Information Act (FOIA). Information about filing a FOIA request is at https://www.nih.gov/institutes-nih/nih-office-director/office-communications-public-liaison/freedom-information-act-office.

Do universities (or other non-Federal entities) need to maintain separate labs for conducting research with hESC lines that do not meet the NIH Guidelines?

NIH does not require universities to maintain separate labs for ineligible hESC research, but only requires that the costs (both direct and indirect) be segregated properly, using the same principles as apply to other research supported by both NIH and other sources of funding. Some institutions choose to address the segregation of costs issue by creating separate facilities. Long standing accounting requirements for Federal projects provided in Federal cost principles (implemented at 2 C.F.R. Part 200, Subpart E (for direct costs) and 45 CFR 75, Subpart E (for indirect costs)) assure that costs charged to Federal projects do not improperly subsidize unallowable costs.

Can universities (or other non-Federal entities) allow equipment that was purchased with NIH funds to be used on non-federally supported projects?

Yes, consistent with Federal law (Federal Grant and Cooperative Agreement Act, 31 U.S.C. 6306) and Federal regulation (2 C.F.R 200.313(c)), universities can allow equipment that was purchased with NIH funds for Federally-supported research projects to be used on non-Federally supported projects, in addition to the original purpose(s) in furtherance of the grant activities, provided that such use will not interfere with the purpose for which it was originally acquired.

For projects studying human germ cells and/or gametes in animal models: how could an institution demonstrate that it will be in compliance with Section IV.B. of the NIH Guidelines for Human Stem Cell Research (no research involving the breeding of animals where the introduction of hESCs or hiPSCS may contribute to the germ line)?

The institution and principal investigator could develop a long-term plan, addressing the following points:

The specific animal housing and oversight arrangements to ensure that no accidental/inadvertent breeding can occur.

A plan to sterilize or euthanize the animals when the NIH-funded experiment is complete. The euthanasia method should be compliant with the AVMA Guidelines for the Euthanasia of Animals or scientifically justified.

A plan to ensure that the gametes from the animals will never be mixed with opposite sex gametes from any species, and will never be used to attempt to create embryos (including chimeric embryos), either in vitro or in vivo, either using NIH or non-NIH funds.

A plan for how the gametes or germ cell progenitor tissues will be tracked while in storage, both during and after the completion of the NIH-funded experiments.

For research to develop human gametes in nonhuman primates or other social animals: the applicant could consider obtaining IACUC approval prior to submission to NIH to ensure that the housing plan is also appropriate for the animal's social welfare.

NIH GPS Section 4.2.4
Does NIH have a mechanism to consider whether research proposals involving human embryos can be supported by NIH?

Yes. The NIH Human Embryo Research Steering Committee determines whether particular proposed research is supportable by NIH given the limitations detailed in the NIH Grants Policy Statement Sec. 4.2.4 (for extramural research; the same limitations apply to NIH intramural research). The Steering Committee is composed of NIH staff with expertise in reproductive biology, law, policy, and NIH processes to review research proposals. Questions can be sent to the attention of this Steering Committee through the following email: [email protected].

Can NIH-supported researchers create or use human stem cells that have the ability to develop into all embryonic and extra-embryonic cell types?

If the cells could be considered an organism, as described in the NIH Grants Policy Statement Section 4.2.4, then such research is subject to the limitations described in Section 4.2.4. Note that NIH considers a human totipotent cell to be an organism under NIH Grants Policy Statement Section 4.2.4.

Will NIH support research to create or use models of human embryos, sometimes referred to as "human embryoids"?

NIH will not support research with a model that could be considered a human organism per the NIH Grants Policy Statement Section 4.2.4. NIH considers the characteristics of the specific model; see Sharing Our Current Thinking: Models Containing Aspects of Human Embryos. While NIH continues to make decisions on a case-by-case basis, the research community should be aware that NIH has supported research with some human 2-dimensional micropattern cultures. NIH has also decided that the agency may not support research with some human blastula-stage models composed of epiblast and extra-embryonic cells in a relatively normal spatial orientation.

Other Policy Questions
May individual states pass laws to permit human embryonic stem cell research?

Yes, individual states have the authority to pass laws to permit human embryonic stem cell research using state funds.

The 2009 NIH Guidelines for Human Stem Cell Research focus primarily on pluripotent stem cells derived from human embryos. Is there NIH policy that applies to research using human fetal tissue?

Per NOT-OD-26-028, effective January 22, 2026, NIH funds are not permitted for research using human fetal tissue (HFT) from elective abortions. NIH funds are permitted for use of research involving HFT obtained from miscarriage or stillbirth, which are subject to requirements outlined in NOT-OD-15-143 and NOT-OD-16-033.

The governing Federal statute on human fetal tissue research and transplantation is found in sections 498A and 498B of the PHS Act, 42 U.S.C. 298g-1 and 298g-2 (also see NOT-OD-15-143). The statute specifically prohibits any person from knowingly acquiring, receiving, or transferring any human fetal tissue for valuable consideration, and requires certain safeguards in transplantation research. In addition, NIH expects informed consent to have been obtained from the tissue donor for any NIH-funded research using human fetal tissue (see NOT-OD-16-033). See NIHGPS 4.1.15 for additional details for grants and cooperative agreements.