Here is a link to the FDA page regarding tissue issues. www.fda.gov/BiologicsBloodVaccines/TissueTissueProducts/QuestionsaboutTissues/ucm101559.htm insert-text-here My understanding is that ACTC's product does not fall under this definition as the esc's are not listed in the "derived from" list. IMO, some of this may change based on this ACTC trial.