Guidelines for Stem Cell Research and Clinical Translation

The International Society for Stem Cell Research (ISSCR) produces research guidelines every five years with the intention of promoting responsible advances in research and clinical applications of stem cell biology. The 2016 guidelines provide a number of recommendations on clinical and ethical principles, including protocols for provision of biomaterials, informed consent processes, documentation, safety and efficacy, privacy, reporting of clinical trials, and other matters for clinical practice.

ISSCR Guidelines: Heritable Genome Editing

The International Society for Stem Cell Research (ISSCR) revised its guidelines for research on Heritable Human Genome Editing in 2021. These guidelines identify the implantation of gene-edited embryos as belonging to Category 3A because it is “currently unsafe or raise[s] unresolved ethical issues.” The authors note that there may be a potential pathway to allowing such research in the future.

Guidelines for Stem Cell Research and Clinical Translation

The ISSCR is an international body founded in 2002 that harmonizes global ethical standards and regulation for research with embryos, stem cells and gametes. The organization updated its 2016 guidelines to accommodate scientific advances in embryo research, embryo models, organoids, chimeras, genome editing, and mitochondrial replacement techniques. Of particular interest is the relaxation of the 14-day rule for in vitro embryo culture. Recommendation 2.2.2.1 of the report puts into question whether certain circumstances justify culture of embryos beyond 14 days.