FAQs: Appendix B
- What type of information is sufficient to explain how to prevent chimeric animals from breeding?
- What type of information do I provide to justify the transplantation of hESCs into animals?
What type of information is sufficient to explain how to prevent chimeric animals from breeding?
Maintenance of animals in separate cages would ensure an inability to breed. Furthermore, GIM 36 stipulates that any animal that receives human cells is autoclaved or incinerated following the study.
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.