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:

  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 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.
  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.

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.

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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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Other UCI Reviews that May be Applicable

IRB

Stem Cell Projects that Require
Institutional Review Board (IRB) Review

Activities that meet the federal definition of human subjects research require UCI IRB review and approval:

  • Interactions or interventions with living individuals
    Examples: Identifying patients for donation of residual (fresh) or stored (frozen) embryos for research; clinical investigations involving the use of human stem cells.
  • Private, identifiable information about living individuals
    Example: Information about the donor(s) is linked to the embryos or cell lines (e.g., medical information) to be created or used.

Notes:

  • If IRB review is required, hSCRO approval is required before IRB review can proceed. hSCRO comments, including hSCRO approval must be provided to the IRB at the time of their review. ORA staff will facilitate the review process for investigators.
  • All required regulatory committee approvals must be in place before stem cell activities may begin.

Institutional Review Board (IRB)

Responsibilities

  • The IRB reviews and approves, requires modifications in, or disapproves the derivation and use of human stem cells to assure appropriate procurement of gametes, blastocysts, fetal tissue or somatic cells for the purpose of generating new stem cell lines, including the procurement of blastocysts in excess of clinical need from infertility clinics, blastocysts made through in vitro fertilization specifically for research purposes, and oocytes, sperm and somatic cells donated for development of human embryonic stem cell lines through nuclear transfer.
  • The IRB reviews, approves, requires modifications in, or disapproves human stem cell activities to ensure proper consent from the donors of sperm, oocytes, or somatic cells used to make blastocysts for research.
  • The IRB reviews, approves, requires modifications in, or disapproves human stem cell activities to assure the privacy of donors in accordance with HIPAA and CMIA regulations for use of personal health information for research purposes.
  • The IRB reviews, approves, requires modifications in, or disapproves human embryonic stem cells activities to assure the privacy of donors in accordance with HIPAA and CMIA regulations for use of personal health information for research purposes.
  • The IRB requests periodic progress reports and oversees the conduct of ongoing human subject protocols involving human stem cell research.
  • The IRB reviews and approves, requires modifications in, or disapproves proposed modifications to approved human stem cell research.
  • The IRB may suspend or terminate approved human stem cell research.
  • The IRB reviews and reports human stem cell research noncompliance in accordance with campus policy for resolving allegations of regulatory noncompliance.

IACUC

Stem Cell Projects that Require
Institutional Animal Care and Use Committee (IACUC) Review

Activities involving vertebrate animals will require UCI IACUC approval.

Institutional Animal Care and Use Committee (IACUC)

Responsibilities

  1. The IACUC is a committee responsible for reviewing all animal use protocols, ensuring compliance with federal regulations, inspecting animal facilities and laboratories, and overseeing training and education programs.
  2. The primary role of the IACUC is to ensure the ethical and humane care and use of animals in research, testing, and teaching.
  3. Human stem cell activities that involve animals require IACUC review approval prior to initiation of the study.

IBC

Stem Cell Projects that Require
Institutional Biosafety Committee (IBC) Review

Activities involving potentially hazardous biological agents including but not limited to infectious agents, human and non-human primate materials (including established cell lines), CDC select agents, recombinant DNA and studies involving human gene transfer will require IBC review.

Institutional Biosafety Committee (IBC)

Responsibilities

  • The IBC is a committee responsible for reviewing activities involving potentially hazardous biological agents including but not limited to infectious agents, human and non-human primate materials (including established cell lines), CDC select agents, recombinant DNA and studies involving human gene transfer.
  • The IBC assures that research involving these agents is conducted in a manner that does not endanger the researcher, laboratory worker, human research subjects, the public or the environment.  In addition, the IBC assures the safe conduct of the research, assesses decontamination and containment levels, and ensures rDNA research is conducted in compliance with the Guidelines for Use of Recombinant DNA Molecules.
  • hSCRO review and approval runs concurrent with IBC review and approval.  The IBC must review and approve all human stem cell activities prior to initiation of the study.