A Scientific, Ethical and Comparative Legal Analysis of the Clinical Application of Human Induced Pluripotent Stem Cells in Germany and Austria 

PI: Professor Jochen Taupitz
CI: Dipl.‑Jur. Univ. Sara Gerke, MA Medical Ethics and Law

Funds: 657,678.00 EUR
Term: 1 April 2016 – 31 March 2018 

The project “ClinhiPS” analyses the clinical application of human induced pluripotent stem cells (hiPSCs) from a scientific, ethical and comparative legal perspective. hiPSCs were first generated in 2007 from adult human cells through transduction of four transcription factors, namely Oct4, Sox2, c-Myc and Klf4. hiPSCs are fully differentiated body cells (such as skin cells) that have been reprogrammed in the laboratory to take on the pluripotent properties of human embryonic stem cells, i.e., stem cells that have the potential to develop into any of the 200 different human cell types; resulting in great excitement across research laboratories  globally. hiPSCs are already utilised as a powerful tool for disease modelling and drug testing and they are clearly paving the way towards clinical application. In order to successfully translate research results into clinical practice, it is essential to identify and analyse the scientific, ethical and legal issues facing the clinical application of hiPSCs at an early stage.

Consequently, this project analyses the scientific and practical background for clinical hiPSC application, thereby examining the overall process from hiPSC generation to the cell therapy itself. It also analyses the ethical challenges associated with clinical implementation of hiPSC therapies. The project draws upon ethical debates in Germany and Austria in comparison to the Anglo-Saxon countries, with the results feeding into the development of ethical guidelines. In addition, the project compares German and Austrian law, thereby showing the legal similarities and differences between offering a future hiPSC therapy in a German and an Austrian clinic. It will reveal legal defects and gaps in the current regulatory approach to the clinical application of hiPSCs in Germany, and will provide recommended actions to the German legislator. The project aims to publish a comprehensive guide to the clinical application of hiPSCs for doctors, researchers, and patients.