UCI Review of 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 Human Stem Cell Research Oversight Committee (hSCRO) before such activities are initiated by or for UCI.

UCI has a Memorandum of Understanding (MOU) with the University of California Santa Barbara (UCSB) to have the UCI hSCRO Committee serve as UCSB’s hSCRO of record. All human stem cell research taking place at UCSB will undergo review and approval by the UCI hSCRO. All UCI hSCRO policies and procedures apply to UCSB researchers performing human stem cell research. Activities reviewed and approved by the UCI hSCRO may still require additional review by the UCSB IRB, IACUC, IBC .

The following definitions of human pluripotent stem cell shall apply:

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 (CIRM Regulations § 100020).

Per CDPH Guidelines for Human Stem Cell Research, "Pluripotent" means capable of differentiation into mesoderm, ectoderm, and endoderm.

UCI hSCRO's Policies: Human Stem Cell Research Oversight (hSCRO) Program Policy and Standard Operating Procedures (SOP)

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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 induced pluripotent stem cells (iPSC)
- human fetal stem cells
- 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 neural derivatives into nonhuman animals at any stage of embryonic, fetal, or postnatal development.
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.

hSCRO review is NOT required for the following:

Adult tissue-derived multipotent or unipotent stem cells
- Mesenchymal cells (e.g., isolated from bone marrow, peripheral blood etc.)
- Hematopoietic stem cells (HSC's)
- Adult stem cells (for example cardiac stem cells)
- Cord blood cells
Non-UCI collaborator/site/ Sponsor will create pluripotent stem cells from biospecimens collected at UCI. For example, skin biopsy samples are collected at UCI and sent to a non-UCI sponsor to genetically manipulate to obtain induced pluripotent stem cells.
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).
Components of stem cells that are not viable and cannot be expanded (i.e., RNA / protein samples) received from a collaborator / company and NOT derived from stem cells grown in your laboratory.

All human pluripotent cells or fetal tissue used or derived must meet the definition of “acceptable research materials” as defined in the Acceptably Derived Cell Line checklist.

Derivation of fetal-tissue origin cells of any kind will require, at a minimum, a non-human subjects determination from the IRB.

For NIH supported research that includes human fetal tissue obtained from elective abortions collected after June 5th, 2019 – 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.

** Per California Department of Public Health Guidelines for Human Stem Cell Research as recommended by the Human Stem Cell Research Advisory Committee pursuant to Health and Safety Code §125118.

Need Additional Guidance?

Check Out Our "Do you need hSCRO Review" Decision Flowchart

Decision Flowchart