Projects

 

No.

Title of project

Type of project

Funder

Type of research

Period

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

International

Frame

Programme 7

European Commission

Clinical trial

2012-2015

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

Beginning with January 2012, the European Union is funding 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.

For this reason a team from Hannover Medical School between May 2009 and September 2013, analyzed 199 blood samples taken from 47 patients with a mean age at implantation of 16.6±10.8 years. Absolute counts and percentages of all cell type subsets, e.g. T-cells, B-cells and natural killer- cells, were determined by modern cell counting techniques (FACS).

Continued assessment up to 3 years after implantation did not show any significant deviations in cell counts from their individual baseline values. The authors concluded that the absence of cellular immune response in patients receiving decellularized homografts supports the concept that decellularization can provide a basis for autologous regeneration.

The ESPOIR consortium comprises eight leading European pediatric cardiology centers, 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.

More information find here: http://www.espoir-clinicaltrial.eu/

Project Partners:

  1. Medizinische Hochschule Hannover (MHH)
  2. Nicolae Testemitanu State University of Medicine and Pharmacy (SUMPh), Chisinau, the Republica Moldova
  3. Leids Universitair Medisch Centrum (LUMC)
  4. Great Ormond Street Hospital For Children (GOSH)
  5. Università Degli Studi Di Padova (UNIPD)
  6. Universite Paris Descartes (UPD)
  7. Azienda Ospedaliera Di Padova (AOP)
  8. Universität Zürich (UZH)
  9. University Hospital Gasthuisberg Leuven (K.U.Leuven)
  10. Corlife Gbr (CORLIFE)
  11. Deutsche Gesellschaft Für Gewebetransplantation Ggmbh (DGFG)
  12. European Homograft Bank (EHB)
  13. Gottfried Wilhelm Leibniz Universität Hannover (LUH)