Stem cells are cells that have the potential to differentiate into specialized (tissue specific) cell types.

hESCs typically come from the inner cell mass of embryos that have grown to the blastocyst stage, beyond 100 cells.

IPS cells are typically derived by the reprogramming of cells that are not pluripotent in order to create pluripotent cells.

Derivatives are the biological materials derived from pluripotent stem cells such as DNA, RNA, proteins, and any other products extracted from stem cells.

Any research use of hESCs:

• Use of commercially available, de-identified hESCs
• Use of existing hESC lines from prior studies approved by GESCR or IRB
• Use of newly derived hESCs from current studies approved by GESCR or IRB
• Banking of hESCs
• Derivation of new pluripotent hESC
• Development of hESCs into gametes (sperm/oocytes)
• Projects that involve animal reproductive function (IACUC approval also required)
• Injection/transplantation of hESCs or their derivatives into any non-human animals (IACUC approval also required)
• Injection/transplantation of hESCs or their derivatives into human subjects

Any research use of iPS cells:

• Use of commercially available, de-identified iPS cells
• Use of existing somatic cells from  prior studies approved by GESCR or IRB
• Derivation of iPS cells from newly collected somatic cells (IRB approval also required)
• Derivation of iPS cells from de-identified existing somatic cells already collected
• Banking of iPS cells
• Development of iPS cells into gametes (sperm/oocytes)
• Projects that involve animal reproductive function (IACUC approval also required)
• Injection/transplantation of iPS cells into non-human animals (IACUC approval also required)
• Injection/transplantation of iPS cells into human subjects (IRB approval also required)

• Use of reproductive quality oocytes (capable of being fertilized) in research that is not directed towards improving reproductive outcomes in infertility treatment
• Donation and research use of oocytes deemed unacceptable for assisted reproductive technology care.
• Creation of pluripotent cells and stem cell lines from gametes and the downstream uses of these pluripotent cells and their derivatives, including:
  • Parthenogenesis
  • Somatic Cell Nuclear Transfer (SCNT)
  • Creation of embryos expressly for research
  • Androgenesis
• Any injection/ transplantation into non-human animals
  • Oocytes
  • Sperm
• Sensitive research projects involving human gametes that raise symbolic concerns or concerns about human dignity
• Procurement and banking of human gametes (oocytes, ovarian tissue, sperm, testicular tissue) for research purposes
• Any protocols for which the IRB requests formal GESCR review. In addition, the IRB may request that the GESCR Chair or Committee members assist in the IRB review.

Generally, research whose goal is improving reproductive outcomes in infertility treatment does not require GESCR approval.

Research involving cells that are, will, or could become pluripotent must undergo GESCR review.

• All CIRM funded research, regardless of tissue/cell type, must undergo a GESCR review
• Research involving processing of adult stem cells that significantly modifies/alters their capabilities
• A Phase I or Phase II clinical trial of a new, commercially manufactured stem cell product which has not previously undergone GESCR review. (Example: The early Prochymal studies underwent GESCR review. Further GESCR review of Prochymal studies is no longer required. IRB review is still required.)
• Injection/transplantation of neural progenitor cells into non-human animals
• Injection/transplantation of adult human stem cells into non-human animals that are expected to cause morphologic changes that are characteristically human
• Development of human stem cells into gametes (sperm/oocytes)
• Projects that involve human stem cells and animal reproductive function