The International Society for Stem Cell Research (ISSCR) is pleased that the U.S. National Institutes of Health (NIH) is considering an end to the moratorium on NIH funding of human-animal chimera research involving the introduction of human pluripotent cells into early stage animal embryos (NIH Notice, 8-4-16).
“Historically, the study of animal models containing human cells has produced valuable insights into human biology and disease,” said ISSCR president Sally Temple. “Research using chimeras can be transformative,” she said. “Scientists will be able to gain new understandings of human development, generate disease models that can be studied and tested, and potentially develop human organs that can be used for transplantation. We are confident that rigorous, responsibly-monitored research in this area will lead to great advances in science, and to developments for the field of regenerative medicine,” she said.
The NIH proposal defines a stringent review process for studies that incorporate human pluripotent stem cells – those that can potentially turn into any cell type in the body – into non-human animals, a process known as chimerism. An independent NIH advisory steering committee will be established to provide input regarding the conduct of research, animal welfare concerns, and other issues. This aligns with the ISSCR’s 2016 Guidelines for Clinical Research and Translation Recommendation 2.1.5, which calls for specialized oversight grounded in rigorous scientific knowledge and ethical considerations and with a diligent application of animal welfare principles. Reviewers are referred to an ISSCR Advisory Report as well as the guidelines for information on best practices in this type of research.
The ISSCR will submit comments to the NIH during its 30-day public comment period.