Concept / Funding
Beginning in January 2012, the European Union will fund the European Clinical Study for the Application of Regenerative Heart Valves (ESPOIR) trial, coordinated by the Hannover Medical School, Germany, with a grant of 5.2 Million Euros for a period of four years. The aim of ESPOIR is to transplant a heart valve, which is tolerated by the patient’s immune system, lasts a lifetime and, for children, even holds the potential to grow with the patient.
The current gold standard for the treatment of certain heart conditions is the implantation of mechanical or biological heart valves. However, both of these approaches also hold significant disadvantages. Mechanical valves require lifetime medication to thin the patient’s blood, which can be dangerous for children or pregnant women. For this reason, clinicians often prefer to use biological heart valves derived from humans or animals. However, these valves also degenerate within eight to ten years, so that after this time, the valve needs to be replaced again. Each re-operation entails a higher risk for the patient, and the mortality risk increases in proportion to the number of re-operations. To address this problem, the ESPOIR consortium will test an innovative new approach using decellularised donated human (homograft) valves.
The ESPOIR consortium comprises eight leading European pediatric cardiology centres, two tissue banks, the German Society for Tissue Transplantation and the European Homograft bank, who will provide the heart valves, and an innovative SME corlife, who will process the donated valves. Project management for the study will be organized by the Leibniz University Hannover.