Translation of regenerative therapies to the patient-bench-to-bedside-is one of the global multidisciplinary challenges of our time. New cell-based therapies are reaching the clinic through staged trials leading eventually to routine adoption. The roots of stem cell therapy lie in surgical practice and transplantation medicine with multiple multidisciplinary challenges emerging to support the new therapies. Control of stem cell behavior in line with regulatory confidence is an example of these challenges. One successful journey from bench-to-bedside is the generation of cartilage through autologous cell-based approaches for use in the repair of the knee joint. An analysis of this journey in Europe reveals success and failure; new initiatives include adopting more quantitative modelling and "organ on a chip" approaches to be used in clinical translation reducing experimental time and redressing the lack of preclinical models. The current state and challenges for the field are outlined with the question posed, "are we there yet?"
Keywords: models; clinical translation; preclinical; regenerative medicine; regulation.