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Activities that Require hSCRO Review

Policy Statement

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. This review requirement applies to the use of human gametes and embryos (e.g., blastocysts), the derivation and/or use of human embryonic (hESCs) or fetal stem cells, induced pluripotent stem cells (iPS) derived from adult cells, any cells which can differentiate into a gamete, and any other human pluripotent stem cells.

It is not necessary to obtain hSCRO approval for adult tissue specific stem cells such as hematopoietic cells or mesenchymal cells unless such cells have been shown to, or are being induced to differentiate into the three major germ lines.

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, and may be permitted following hSCRO approval:

All research or clinical investigations that involve the following activities:

  1. Generation of new lines of human pluripotent stem cells from whatever source and by whatever means.
  2. Use of human gametes, human embryos, human adult pluripotent, human fetal tissue, human fetal stem cells, or, human embryonic stem cells.
  3. Transplantation of neural stem cells into humans.
  4. 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; provided that investigators evaluate the probable pattern and effects of differentiation and integration of the human cells into the nonhuman animal tissues.
  5. 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.

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 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).

Activities that are not permitted and will not be approved by the UCI hSCRO include, but are not limited to, the following:

  • 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.

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