Subproject 1: Scientific Fundamentals
A Scientific, Ethical and Comparative Legal Analysis of the Clinical Application of Human Induced Pluripotent Stem Cells in Germany and Austria (ClinhiPS) – SP1: Scientific Fundamentals
Fraunhofer Institute for Biomedical Engineering IBMT
Project number: 01GP1602B
Funds: 182,763.00 EUR
Term: 1 April 2016 – 31 March 2018
The aim of subproject 1 is to analyse the scientific background and aspects of the clinical application of human induced pluripotent stem cells (hiPSCs). Clinical use of stem cells is obligatory as prerequisite for the implementation of Regenerative Medicine and Tissue Engineering. Up to now, no reliable clinical results are available with regard to hiPSCs. Consequently, it must be assessed how the overall process can be established to meet not only the clinical guidelines but also to make this therapeutic option applicable for large groups of patients. For this purpose, the individual process steps must be evaluated from the scientific point of view not only in terms of medical and biological aspects, a variety of laboratory and quality management issues have also to be taken into account. Moreover, side effects may occur decades after a successful stem cell therapy. Therefore, a continuous postoperative monitoring, as well as acquisition and management of patient-specific data are required. The detailed analysis of the scientific background is the prerequisite for the subsequent identification and assessment of risks, ethical problems and legal issues and thus forms the basis for the other subprojects.