Partner 1: Medizinische Hochschule Hannover (MHH)

Coordinator, WP Leader for WP1 & 4, Clinical centre

The Hannover Medical School (Medizinische Hochschule Hannover, MHH), founded in 1965, is one of the world's leading university medical centres. The MHH consistently ranks among the top three medical faculties in Germany with respect to peer-reviewed grant income and funding volume per professor. Third-party funding totalled 94.8M€ in 2012, including 65 funded projects under FP7, with three coordinated projects, one coordinated International Training Network and two ERC grants. Due to its interdisciplinary research MHH has strong collaborative links with many academic and industrial research organizations worldwide. Research at the MHH focuses on unravelling basic mechanisms and, in close collaboration with clinical facilities, translating these findings into clinical research. Building on a broad expertise in medicine, immunology, biochemistry, structural biology, genetics, cell biology and infectious diseases, MHH researchers study human diseases and develop innovative strategies for diagnosis, prevention and therapy. The main research activities focus on transplantation and stem cell research, infection biology and immunology as well as biomedical technology and implants. In the clinical arena, the MHH has gained international recognition for its programmes in cell therapy, transplantation medicine, and device therapy and is one of the largest transplantation centres worldwide.

The ARISE project will be carried out by the Department of Cardiac-, Thoracic-, Transplantation and Vascular Surgery (HTTG). The HTTG ranks among one of the most research-active surgical units, both nationally and internationally. It has a long history in innovative cardiac surgery and heart transplantation (HTX) with over 1100 HTx performed since 1983. Patients with cardiovascular disease are treated in the HTTG in cooperation with the Department of Paediatric Cardiology, and the Department of Cardiology. The large number of patients treated and the corresponding clinical data base provide an excellent basis for basic, translational and clinical research.

Within the HTTG, the Leibniz Laboratories for Biotechnology and Artificial Organs (LEBAO, founded in 1996 by Professor Haverich) focuses on stem cell research and tissue engineering. LEBAO’s extensive expertise and progress provided the pivotal foundation for the establishment of the Excellence Cluster “REBIRTH – From Regenerative Biology to Reconstructive Therapy” funded under the German Excellence Initiative since 2007. The HTTG is furthermore a partner in the Hannover site of the German Centre for Lung Research “BREATH” and is a pivotal member of the Lower Saxony Centre for Biomedical Engineering, Implant Research and Development (NIFE) which connects transdiscplinary research and development in the field of innovative implants along the innovation chain.

The technique of decellularisation was developed and evaluated in the HTTG in extensive large animal studies, including long-term studies in sheep. In a breakthrough approach, Haverich et al. pioneered the first tissue-engineered, pulmonary heart valves, which were shown to grow with the patient after implantation. These decellularised pulmonary valves have been applied in the clinic since 2008 and are currently being evaluated in the EU-FP7 project ESPOIR (Grant Agreement 278453), a large multicentre study coordinated by Professor Haverich. In addition, various approaches for pre-vascularised matrices are currently being developed and tested in large animal models. The ARISE project will extend and further develop this approach to aortic valves.

Main tasks

The MHH will be responsible for the overall coordination of ARISE (Professor Haverich) and the management of WP4 Clinical Study (Dr. Sarikouch). The main tasks will be:

  • Overall project management, including the coordination of all legal, financial and administrative aspects of the project with the support of a specialized project manager (Partner 9, LUH)
  • Setting up local and national frameworks for the clinical study, e.g. reimbursement agreements, ethics approvals, and coordinating these procedures across all clinical centres
  • The implementation of the clinical trial, patient recruitment and information, operations and follow-up
  • As coordinating clinical centre, to continuously monitor and minimize project risk, implement a risk-management strategy and will undertake corrective measures should issues arise
  • To liaise with tissue banks
  • To organize the establishment of a registry database and procedures for the long-term management of data and follow-up

Contributors to ARISE

Prof. Dr. med. Axel Haverich, Head of HTTG, Coordinator ARISE
PD Dr. med. Samir Sarikouch, Senior Physician, Clinical Trial Director ARISE
PD Dr. med. Dietmar Böthig, Statistician
Dr. med. Serghei Cebotari, Senior Consultant/Surgeon
Dr. med. Igor Tudorache, Senior Consultant/Surgeon, Director ARISE Registry
Dr. Alexander Horke, Senior Consultant/Surgeon
Nina McGuinness, Research Manager
Katrin Fuchs, Study Coordinator