What type of information do I provide to justify the transplantation of hESCs into animals?
If there is a reasonable possibility that, after transplantation of hESCs, the animal will exhibit human-like traits (appearance, cognitive, or behavioral), discuss the procedures that will be implemented for management, documentation and reporting of such occurrences to IACUC and ESCRO.
As a reminder, GIM-36 prohibits the following:
- Implanting a chimeric embryo containing non-human cells, including ESCs, into the uterus of a human;
- Implanting a chimeric embryo containing hESCs into a uterus of a nonhuman primate and allowing the resulting pregnancy to progress to the point of independent viability;
- Breeding of a chimeric animal having hESCs that were introduced during any stage of the animal's embryonic or fetal development;
- Breeding of a chimerical animal having hESCs where there is a reasonable possibility that human genetic material could be incorporated into the animal's germ cells.
In addition, ESCRO has determined that certain categories of induced, pluripotent stem-cell research (iPSC research) require ESCRO review and approval. These categories include the following:
- Transplantation of iPSCs into research animals;
- Transplantation of iPSCs into humans;
- Use of iPSCs to create an embryo.