Regulations/Ethical Guidelines on Human Adult/Mesenchymal Stem Cell Clinical Trial and Clinical Translation

Abstract

There are two parts in this article. In the first part the authors describe the regulatory and ethical challenges caused by stem cell research and its clinical application, especially by the widespread use of unproven and unregulated “stem cell therapy” and the guidelines and regulations for attempting to deal with challenges in China. At the end of this part ethical guidelines for human adult (including mesenchymal) stem cell clinical trials and application is appended. In the second part the authors try to provide an overview of regulations or ethical guidelines on human adult/mesenchymal stem cell clinical translation in USA, UK, the European countries and India. The article concludes with the harmonization of regulating human adult/mesenchymal stem cell clinical translation in the world and the Guidelines for the Clinical Translation of Stem Cells drafted by the International Society for Stem Cell Research provide a basis for the harmonization.