Regulations and Guidelines

Stem cell therapy, in its current form, is not approved by the any government agencies anywhere. Stem cell research is partly regulated. The use of human embryonic tissue for stem cell research requires the destruction of embryos and therefore, is controversially discussed, including the use of surplus embryos that are considered medical waste. The use of human embryonic tissue also has created the fear of the consequence of potential human cloning. The International Society for Stem Cell Research created guidelines for research on human stem cells in 2009. The Stem Cell Therapeutic and Research Reauthorization Act permitted federal funding in 2015. The International Society for Stem Cell Research published its guidelines in 2006 that were revised in 2016 and 2021 for stem cell research and clinical translation. The U.S. FDA has not approved any stem cell therapies, yet, but releases warning notes against unapproved therapies as consumer alerts.