title: Regulating the therapeutic translation of regenerative medicine.
abstract: Regenerative medicine and stem cell research are exciting new fields. But as the fields progress toward clinical therapies, controversies emerge. Hype surrounding stem cell research has caused an increase in their use in interventions that are not clinically proven. Furthermore, the regulatory agencies have a lot of difficulty dealing with cell therapies, which are distinctly different from drugs and medical devices they more commonly approve. To move the field forward, advocates, regulators and scientists need to come together to find new options for stem cell research oversight that protects both the patients and the research field.
authors.affiliation: a Rice University, Baker Institute for Public Policy , 6100 Main Street, MS-40, Houston, TX 77005, USA krwm@rice.edu.
authors.forename: Maude L
authors.initials: ML
authors.lastname: Cuchiara
authors.affiliation: a Rice University, Baker Institute for Public Policy , 6100 Main Street, MS-40, Houston, TX 77005, USA krwm@rice.edu.
authors.forename: Jackie K
authors.initials: JK
authors.lastname: Olive
authors.affiliation: a Rice University, Baker Institute for Public Policy , 6100 Main Street, MS-40, Houston, TX 77005, USA krwm@rice.edu.
authors.forename: Kirstin
authors.initials: K
authors.lastname: Matthews
mesh_terms: D064987:Cell- and Tissue-Based Therapy; D033161:Government Regulation; D006801:Humans; D044968:Regenerative Medicine; D033581:Stem Cell Transplantation; D013234:Stem Cells / Q000166:cytology
keywords: public policy; regenerative medicine; regulation; stem cell tourism; stem cells