With the foundation of the Reference- and Translation Center for Cardiac Stem Cell Therapy (RTC) the research divisions of the Clinic for Cardiac Surgery have been integrated with the Laboratories of Cardiac Tissue and Organ Regeneration and are today connected by the “translation management”. The Clinic for Cardiac Surgery of Rostock and the Research Laboratories of Cardiac Tissue and Organ Regeneration at Rostock University are led by Prof. Dr. Gustav Steinhoff, heart surgeon and scientist.
Accordingly, there are three divisions at the center:
1. The R&D centre at which basic research is conducted for gaining fundamental new insights. The resulting approaches for novel and improved therapies are being pre-clinically tested and developed according to the principles of “Good Practice”. For the manufacturing of stem cell preparations the potentially suitable methods are being evaluated, developed and established according to the principles of “Good Manufacturing Practice”.
2. At the clinical centre investigations are conducted on the safety and efficacy for the application on human beings and patient care. The clinical trials are conducted according to the requirements of “Good Clinical Practice”. In this context, most stem cell preparations are manufactured by means of “Point of Care”- practice according to the requirements of “Good Manufacturing Practice”. For the “therapy vigilance” data are collected, documented in the Registry and, finally, analysed for the evaluation of long term-safety and -efficacy.
3. The translation centre acts as a link between the R&D centre and the clinical centre. With its competence on “Regulatory Affairs” it makes sure that the legal requirements are met during the entire procedure of therapy development. Other various tasks include strategy, organisation, networking and, in particular, planning and preparation of studies. Furthermore, it is responsible for activities concerning public relation, training and education.