European clinical study for the application of regenerative heart valves (ESPOIR)

© corlife, Hannover

Acquired and congenital heart disease can necessitate heart valve replacement. Current heart valve substitutes, however, are not considered ideal as they need anticoagulation, bear the risk of bleeding when manufactured from non-organic material, or may degenerate when they derive from animals or human tissue donors (homografts). An ideal heart valve substitute would be durable in the long term and even have the potential to grow when implanted in pediatric patients.

Prof. Haverich from the Hannover Medical School and a team of researchers have developed an implant for heart valves that is better tolerated than the known alternatives and which has the potential for regeneration by autologous recellularization. Implants derive from donated homografts, which are chemically treated to inactivate potential microorganisms and viruses. The heart valves are then decellularized chemically, so that only connective tissue remains, the heart valve matrix. Heart valve matrices have been examined in extensive animal studies, including immunological and toxicological analyses and long-term and growth models, which have shown that the implant is well tolerated and is recellularized by the recipient.

The ESPOIR (European clinical study for the application of regenerative heart valves) project is based on auspicious early clinical results in children and young adults. In order to drive the translation of this promising regenerative approach into practical clinical use and to reduce the number of repeat surgical procedures often necessary with congenital heart defects, the ESPOIR consortium is now performing a prospective multi-center trial to include 200 patients, from 8 European centres, for robust statistical evaluation of outcomes with decellularized heart valve matrices in direct comparison to conventional heart valve substitutes.

The European Union (EU) is funding this project with 5.2 Million Euros for 4 years.

Find more information, please see:
www.espoir-clinicaltrial.eu
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