What are the key international policy positions for the regulation of stem cell-based therapies or clinical trials?
• In 2008, the International Society for Stem Cell Research (ISSCR) convened a task force, comprised of a multidisciplinary group of stem cell researchers, clinicians, ethicists and regulatory officials, to develop the Guidelines for the Clinical Translation of Stem Cells. These guidelines present core principles for the responsible translation (“from bench to bedside”) of basic stem cell research into appropriate clinical applications for treating patients. It is recommended that unproven treatments using stem cells or their derivatives should not, as a rule, be administered to patients outside of an established clinical trial. These guidelines promote international consensus on three major areas of translational stem cell research: i) cell processing and manufacture; ii) preclinical studies; and iii) clinical research. • In Europe, the European Union has introduced regulations to promote harmonization with regards to the authorization and supervision of cell therapy products and othe
