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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:

  1. All research or clinical investigations that involve the derivation/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, but is not limited to:
    • The use of human gametes and embryos (e.g., blastocysts).
    • The derivation and/or use of human embryonic cells (hESCs).
    • The derivation and/or use of induced (reprogrammed) pluripotent stem cells (iPSC).
    • The derivation and/or use of any cells that can differentiate into a gamete or human pluripotent stem cell.
  2. All research or clinical investigations that involve the derivation/use of the following human cell types shall also be reviewed and approved by the UCI hSCRO before such activities are initiated by or for UCI. This review requirement applies to:
    • The derivation of fetal-tissue origin multipotent stem cells.
    • The in vivo transplantation of human neural stem/progenitor cells into the brain of a non-human animal at any state of embryonic, fetal, or postnatal development.
  3. In addition:
    • Activities that are reviewed and approved by the UCI hSCRO may require additional review by the UCI IRB, IACUC, IBC and/or COIOC committees.
    • All human pluripotent cells 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

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 derivitives, that is, differentation 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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