The MUSC Research Using Human Stem Cells Policy (PDF) applies to all research involving the derivation or use of human pluripotent stem cells (hPSCs) at MUSC, to help ensure that such research is conducted with the highest ethical and scientific research standards, and in compliance with all applicable federal and state regulations, MUSC policies, and the requirements of extramural research sponsors.
All research involving the storage of embryonic, and derivation or use of human pluripotent stem cells (hPSCs) at MUSC must be reviewed by the SCRO committee. Research can fall in to 3 categories:
Human stem cell research including, but not limited to, the following categories will be evaluated in an expedited manner:
- Protocols involving purely in vitro research (excluding protocols for differentiation of hPS cells into gametes or other epiblast-derived cell types), which only involve any of the following:
- Human adult stem cells or human cord blood stem cells (however, see Section IV.B.4)
- hESC lines that have been “acceptably derived”
- hPSC lines which have previously been approved for use at MUSC by the SCRO Committee unless there is new information that calls into question renewal or approval
- Existing human induced pluripotent stem cells (iPSC) (excluding research directed at creating an human iPSC with embryonic stem cell quality from a somatic cell), provided one of the following criteria has been met:
- The IRB approved the consent form and process for obtaining the somatic cells used for induction; or
- The SCRO Committee receives written confirmation from a Stem Cell Oversight Committee, an Institutional (IRB), or equivalent oversight body at another institution, that the oversight body approved the process for obtaining the somatic cells used for induction; or
- The process for obtaining the somatic cell used for induction was not “research involving human subjects” within the meaning of Title 45, Part 46 of the US Code of Federal Regulations (45 CFR Part 46).
- The process for obtaining the somatic cells used for induction was exempt from the requirements of 45 CFR Part 46, under 45 CFR Part 46.101(b).
- Cells are linked to one or more protected Health Information identifiers by code and MUSC researchers cannot trace cells back to donor per written agreement or policy. However, the provider of the iPSCs can.
- Protocols involving the introduction of cells suspected to be neural progenitor cells into non-human blastocysts, embryos or fetuses, or into the brain of post-natal non-human animals require full committee review;
- Protocols in which there is a significant possibility that the implanted human stem cells could give rise to functional neural or gametic cells and tissues require full committee review. In considering the likelihood of such an outcome, particular attention should be paid to at least three factors: (i) The extent to which the implanted cells are anticipated to colonize and integrate into the animal tissue, and; (ii) The degree of anticipated differentiation of the implanted cells, and; (iii) The possible effects of the implanted cells on the function of the animal tissue; NOTE: Use that is limited to teratoma formation to test for pluripotency does not require SCRO review.
MUSC prohibits the following categories of research:
- Research involving in vitro culture of any intact human embryo, regardless of method of creation, for longer than 14 days or until formation of the primitive streak begins, whichever occurs first.
- Experiments that involve transplantation of human pluripotent stem cells into human blastocysts.
- Transfer into a human or non-human uterus of experimentally created human or cybrid (a cell with a human nucleus and the cytoplasm of another species) embryos made by any method.
- Research in which human pluripotent stem cells are introduced into mammalian (incl. non-human primate) blastocysts, pending further research that will clarify the potential of such introduced cells to contribute to neural tissue or to the germ line.
- Breeding of animals into which human pluripotent stem cells have been introduced. The full Committee will consider exceptions to this prohibition with a strong scientific rationale for breeding.
- Engaging in human stem cell research deemed ineligible by the National Institutes of Health.
Review that does not fall under expedited categories and is not prohibited, will be reviewed by the convened SCRO Committee.
- Use of human embryonic and iPSC lines not previously approved by the MUSC SCRO committee, irrespective of de-identification.
- Derivation of any pluripotent or multipotent stem cell lines by any means.
- Research involving processing of human adult stem cells that significantly modifies/alters their capabilities
- Human totipotent cells or pluripotent stem cells that are mixed with pre-implantation human embryos. In no case shall such experiments be allowed to progress for more than 14 days of development in vitro, or past the point of primitive streak formation, whichever is first.
- Clinical research in which cells of totipotent or pluripotent human origin are transplanted into living human subjects.
Note: Transplantation of stem cells as part of recognized and accepted medical treatment for a disease or condition will not need SCRO review
- Research involving the introduction of hPSCs into animals (other than humans or primates, see Prohibited Research) at any stage of embryonic, fetal, or postnatal development and in which there is a significant possibility that the implanted cells could give rise to neural or gametic cells and tissues.
- Introduction of human neural stem cells into the central nervous system of any non-human animal (pre- or perinatal) if such progenitors are suspected or documented to have "transdifferentiative" potential in vivo (greater potency than anticipated in vitro). Note: this includes neural stem cells from any source, including but not limited to hES cells, non-embryonic hPSCs, fetal tissue, adult somatic cells, and other non-embryonic sources.