Abstract
The potential of organoids and other stem cell-derived tissue constructs (SCTC) to be used for clinical applications is developing rapidly. Subsequently, there is an increasing need to understand and address the ethical, legal and regulatory issues around their use. There are a range of health, ethical, regulatory and legal issues associated with SCTCs that will evolve as the technology develops and they become more accepted for clinical use. SCTCs can be used for drug screening, phenotypic disease screening and regenerative medicine applications. Each clinical application has different issues and requirements, there is no perfect, one size fits all SCTC that will cover all applications, even where these different applications assess the same treatment, patient or disease. Currently, there is minimal guidance on the use of SCTCs in clinical applications, but the regulatory requirements will depend on the particular application. There is a tension between population based and personalised SCTCs for drug screening, phenotypic disease screening and regenerative medicine applications; whether experimental trials and subsequent delivery of safe and effective treatments for small or individual patient groups can be developed and their financial viability.