Press Release

Tuesday, 20 December 2016

ESPOIR project closing meeting held in Zurich in December 2016

Long-term follow up initiated - the European post-authorisation study on regenerative pulmonary heart valve replacement enrolled 120 patients

December 2016 saw the closing meeting of the ESPOIR project held in Zurich. Within the 5-year project lifetime researchers across Europe worked for the dissemination of the promising technology of decellularising human heart valves prior to implantation as replacement of a malfunctioning pulmonary valve. This concept reduces immunogenicity of the implanted heart valve as less antigens deriving from the donor are present. But it also facilitates recellularisation by recipient cells, thereby holding the potential for regeneration and preservation of the matrix functional structure. An independent Ethics and Governance Council including patient organisations supervised the project in addition to national legal requirements and approval by local ethics committee prior to start of the clinical study.

In the initial phase, which lasted almost three years, corlife oHG, a spin-off of Hannover Medical School, went through the approval process of the decellularized heart valves and the setup of the study with the competent authorities and European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP®). The ESPOIR study is pivotal, as the approval of a decellularized human heart valve, the management of trans-border trafficking of human tissue preparations and the approval of a study with a tissue preparation were for the first time subject to authorization procedures in all participating countries.

After approval of ESPOIR PV the clinical trial started in the setting of a so-called non-interventional trial, which means that the heart valve is implanted according current guidelines and according its authorisation following surgical indication for a decellularised heart valve.

Within two years 120 patients were included to the controlled prospective clinical trial at 7 clinical centres within Europe, please see Figure 2 below. 4 leading Tissue Banks (European Homograft Bank (BE), Deutsche Gesellschaft für Gewebetransplantation (DE), Fondazione Banca dei Tessuti di Treviso (IT) and Euro Heart Valve Bank (NL) within Europe closely collaborated within the ESPOIR project and procured human heart valves, which were sent for decellularisation to Corlife oHG.

After allocation of the processed heart valve by the providing Tissue Bank to a specified recipient at one of the implanting hospital the processed heart valves were implanted using standard surgical procedures. ESPOIR PV implantation proved to be safe and simple, no adverse events relating to the mechanical stability of the decellularized matrix structure occurred. The ESPOIR investigators will report their early experience in comparison to matched contemporary cohorts within the participating hospitals in 2017.

The study is amended by the ESPOIR Registry, surveying all patients having received a 'decellularized human pulmonary valve, Espoir PV' within or outside the ESPOIR study for at least 10-years. This will allow robust assessment of decellularised heart valves for pulmonary valve replacement, including but not limited to diameter development and regenerative capability. The ESPOIR Registry to date comprises data of 230 patients.

Corlife oHG provides the service of heart valve decellularisation to any interested Tissue Bank or Hospital fulfilling the European Directives on tissue donation. Corlife is acknowledging well established allocation procedures. The fee for such processing is uniform and fully reimbursed by the health insurance systems in Germany, Austria, Switzerland and Japan. 



The technique for decellularisation was developed and patented at Hannover Medical School by A. Haverich and co-workers. A. Haverich holds shares in Corlife oHG.

The ESPOIR study is supported by a grant from the European Union’s Seventh Framework Programme for Research, Technological Development and Demonstration under Grant Agreement No. 278453