UCI Reviews for Stem Cell Research
All research or clinical investigations that involve the use of pluripotent human stem cells shall be reviewed and approved by the UCI hSCRO before such activities are initiated by or for UCI.
The following definition of human pluripotent stem cell population shall apply (CIRM Regulations § 100020):
A cell that is capable of: (1) sustained propagation in culture; and (2) self-renewal to produce daughter cells with equivalent developmental potential. This definition includes both embryonic and non-embryonic human stem cell lines regardless of the tissue of origin. "Pluripotent" means capable of differentiation into mesoderm, ectoderm, and endoderm.
Activities that require UCI hSCRO review:
All research or clinical investigations that involve the following activities:
- Generation of new lines of human pluripotent stem cells from whatever source and by whatever means.
- Use of human gametes, human embryos, human adult pluripotent, human fetal tissue, human fetal stem cells, or, human embryonic stem cells.
- Transplantation of neural stem cells into humans.
- Activities involving the introduction of human adult pluripotent, human fetal tissue, human fetal stem cells, human embryonic stem cells, or their neuralderivatives into nonhuman animals at any stage of embryonic, fetal, or postnatal development; provided that investigators evaluate the probable pattern and effects of differentiation and integration of the human cells into the nonhuman animal tissues.
- Activities in which the identity of the donors of blastocysts, gametes, or somatic cells from which human stem cells were derived is readily ascertainable or might become known to the investigator.
Additional requirements:
Activities that are reviewed and approved by the UCI hSCRO may require additional review by the UCI IRB, IACUC, IBC and/or COIOC committees. The review of other regulatory committees will be in parallel with the hSCRO review.
All human pluripotent cells or fetal tissue used or derived must meet the definition of “acceptable research materials” as defined in the Acceptable Research Materials checklist.
Derivation of fetal-tissue origin cells of any kind will require, at a minimum, a non-human subjects determination from the IRB.
Once this research study has received hSCRO approval, any subsequent changes to the research plan, research team or research materials (such as source material or cell lines) will be submitted for review and approval by hSCRO. Exception: updates can be made at the time of continuing review when generation of new cell lines is ongoing from previously verified material if collected under an active UCI IRB-approved protocol
If source materials such as skin biopsies, blood, fibroblast cell lines or any other applicable materials are procured with the intent of creating induced pluripotent cell lines, an amendment must be submitted for hSCRO review and approval PRIOR to generating the iPSCs to ensure the provenance can be verified prior to making the significant efforts to generate iPSCs.
For NIH supported research that includes human fetal tissue obtained from elective abortions collected after June 5th, 2019 from elective abortions, the definition of fetal tissue includes human extra-embryonic cells and tissue, such as umbilical cord tissue, cord blood, placenta, amniotic fluid, and chorionic villi.
Note: if isolated postnatally (following birth), ‘human extra-embryonic cells and tissue, such as umbilical cord tissue, cord blood, placenta, amniotic fluid, and chorionic villi’ are NOT considered FETAL tissue per NIH definition mentioned above.
Investigators should be aware of specific NIH requirements – please visit Use of Human Fetal Tissue in Research.
UCI hSCRO Administrative review of these requirements will be provided to investigators upon request (submit your inquiry to hSCRO@uci.edu) to assist in meeting these requirements.

Activities that are not permitted
The following (non-exhaustive) list of activities will not be approved by the UCI hSCRO:
- The culture in vitro of any intact human embryo, regardless of derivation method, after the appearance of the primitive streak or after 12 days whichever is earlier. The 12-day prohibition does not count any time during which the blastocysts and/or cells have been stored frozen.
- The introduction of human embryonic stem cells (hESCs) into nonhuman primate blastocysts and/or the introduction of any hESCs into human blastocysts.
- The breeding of an animal into which hESCs have been introduced at any stage of development.
- Introduction of hESCs into a human uterus or equivalent, or any experiments attempting human reproductive cloning.
Activities that do not require UCI hSCRO review:
- It is not necessary to obtain hSCRO approval for adult tissue-derived multipotent or unipotent stem cells (e.g. hematopoietic cells, mesenchymal stem cells, bone-marrow stromal cells) unless such cells have been shown to be, have been induced to be, or will be induced to be pluripotent as defined above.
- In vitro generation or use of human iPSC derivatives, that is, differentiation of human iPSCs already approved on an existing hSCRO protocol in the PI’s laboratory into a new multipotent or unipotent cell lineage, unless they meet one of the other requirements above (e.g., in vivo transplantation of neural stem/progenitor cells of any origin).
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