PURPOSE: Recent advances in tissue engineering have prompted research on cell sheet techniques to repair the damage on different organs using a variety of transplanted cells. Like traditional medicines the technique of preparing a cell sheet is similar. However, the culture period and tissue/cartilage production vary for cell sheets with different therapeutic applications. This workshop will use cell sheet therapy as a case study to introduce the application of indication-based therapy in regenerative medicine and provide guidance on how to conduct such pricing by considering different stakeholder perspective in two different therapeutic applications. DESCRIPTION: The session will start with an introduction of standard cell sheet therapy for treating cardiomyopathies and damaged knee cartilage. We will present results of the manufacturing cost analysis for each treatment option, discuss the variation of manufacturing cost among different therapeutic areas, and discuss the components of potential affordable pricing for manufacturer, payer, provider and patient. Consideration also will be given to patient topics such as accessibility, affordability. At the end, we will compare and contrast both the consistency and variation of treatments and consider a new approach to pricing to support HTA by individual countries and provide guidance to companies and research organizations on the appropriate evidence to support such pricing. These components take the cost of manufacturing, delivery device, and treatment technique, the frequency of receiving treatment, and the outcome into consideration. The workshop will include an extended interactive Q&A session.