Skip to main content

European clinical study for the application of regenerative heart valves

Objective

Acquired and congenital heart disease can necessitate heart valve replacement. However, current heart valve substitutes are not considered ideal as they need anticoagulation, bearing the risk of bleeding when manufactured from non-organic material, or they degenerate when they derive from animals or human tissue donators (homografts) thereby leading to frequent reoperation especially in the young population. An ideal heart valve substitute would overcome these limitations and even have the potential to grow when implanted in pediatric patients.

Haverich et al. have developed an implant for heart valves, which 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 then are decellularized chemically, so that only connective tissue remains, the matrix of the decellularized heart valve (DHV). DHV has been examined in extensive animal studies, including immunological and toxicological analysis, long term and growth models, all of which have shown that the implant is well tolerated and spontaneously recellularized by the recipient.

The proposed ESPOIR project is based on auspicious early clinical results in 45 children and young adults. In order to drive translation of this promising regenerative approach towards practical clinical use and to reduce the burden of congenital heart defects in particular, the ESPOIR consortium will undertake a prospective multi-centre trial to include at least 200 patients from 8 leading European Centres for Congenital Heart Surgery, for robust statistical evaluation of DHV in direct comparison to conventional heart valve substitutes.

Call for proposal

FP7-HEALTH-2011-two-stage
See other projects for this call

Funding Scheme

CP-FP - Small or medium-scale focused research project

Coordinator

MEDIZINISCHE HOCHSCHULE HANNOVER
Address
Carl-neuberg-strasse 1
30625 Hannover
Germany
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 1 030 588,67
Administrative Contact
Frank Dittrich (Mr.)

Participants (14)

ASSOCIATION INTERNATIONALE EUROPEAN HOMOGRAFT BANK AISBL

Participation ended

Belgium
Address
Rue Bruyn 200
1120 Brussesls
Activity type
Other
Administrative Contact
Ramadan Jashari (Dr.)
HAVERICH DR.AXEL, MEYER-KOBBE, DR.CLEMENS GBR

Participation ended

Germany
Address
Feodor Lynen Strasse 23
30625 Hannover
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Michael Harder (Dr.)
UNIVERSITATEA DE STAT DE MEDICINA SI FARMACIE NICOLAE TESTEMITANU DIN REPUBLICA MOLDOVA
Moldova
EU contribution
€ 213 240
Address
Stefan Cel Mare Avenue 165
MD2004 Chisinau
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Anatol Ciubotaru (Prof.)
ACADEMISCH ZIEKENHUIS LEIDEN
Netherlands
EU contribution
€ 324 367,83
Address
Albinusdreef 2
2333 ZA Leiden
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Mark Hazekamp (Prof.)
GREAT ORMOND STREET HOSPITAL FOR CHILDREN NHS FOUNDATION TRUST
United Kingdom
EU contribution
€ 354 526,51
Address
Great Ormond Street
WC1N 3JH London
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Anna Ferrant (Dr.)
UNIVERSITA DEGLI STUDI DI PADOVA
Italy
EU contribution
€ 195 233,20
Address
Via 8 Febbraio 2
35122 Padova
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Francesco Sartori (Prof.)
UNIVERSITE PARIS DESCARTES
France
EU contribution
€ 378 411,98
Address
Rue De L Ecole De Medecine 12
75270 Paris Cedex 06
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Rosaly Datchi (Ms.)
AZIENDA OSPEDALE UNIVERSITA PADOVA
Italy
EU contribution
€ 132 690
Address
Via Nicolo Giustiniani 1
35128 Padova
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Antonio Giona (Dr.)
University of Zurich
Switzerland
EU contribution
€ 326 012,83
Address
Ramistrasse 71
8006 Zurich
Activity type
Higher or Secondary Education Establishments
Administrative Contact
René Prêtre (Prof.)
CORLIFE OHG
Germany
EU contribution
€ 1 112 831,20
Address
Feodor Lynen Strasse 23
30625 Hannover
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Michael Harder (Dr.)
DEUTSCHE GESELLSCHAFT FUR GEWEBETRANSPLANTATION GEMEINNUTZIGE GESELLSCHAFT MBH
Germany
EU contribution
€ 345 783,28
Address
Feodor Lynen Strasse 21
30625 Hannover
Activity type
Other
Administrative Contact
Martin Börgel (Mr.)
CLINIQUE SAINT-JEAN - KLINIEK SINT-JAN
Belgium
EU contribution
€ 374 300
Address
Boulevard Du Jardin Botanique 32
1000 Bruxelles
Activity type
Other
Administrative Contact
Ramadan Jashari (Dr.)
GOTTFRIED WILHELM LEIBNIZ UNIVERSITAET HANNOVER
Germany
EU contribution
€ 174 742,40
Address
Welfengarten 1
30167 Hannover
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Sonja Kress (Ms.)
KATHOLIEKE UNIVERSITEIT LEUVEN
Belgium
EU contribution
€ 237 272,10
Address
Oude Markt 13
3000 Leuven
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Tine Heylen (Ms.)