Consortium for Organ Preservation in Europe - COPE

Consortium for Organ
Preservation in Europe
OPE
ʹΠΟΤΠΣΥΚΦΞ͑ΗΠΣ͑΀ΣΘΒΟ͑
΁ΣΖΤΖΣΧΒΥΚΠΟ͑ΚΟ͑ͶΦΣΠΡΖ
The COPE Consortium aims to advance and
develop organ preservation technologies by
performing clinical and translational studies with
on-going experimental refinement. Through
testing the quality and safety, increasing the
efficiency and refining preservation strategies
we aim to bring technologies from the bench
to the bedside with direct impact for patients.
The Clinical Question
More complex solutions
In situ
normothermic
machine perfusion
(NMP)
Static Cold
Storage (SCS)
?
In situ normothermic
regional perfusion
(NRP)
Hypothermic
machine
perfusion (HMP)
Hypothermic machine perfusion
(HMP) with oxygen
Our Research
LIVER
RCT
SCD &
ECD
livers
NMP
POMP
RCT
ECD
kidneys
SCS
COMPARE
RCT
SCS
DCD
>50 years
kidneys
HMP
HMP
O2
O2
SCS
HMP
O2
BIOBANK
Experimental research programmes on liver and kidney preservation
Our Background
The COPE Consortium is the official organ preservation task force of the European Society for
Organ Transplantation and is funded through the EU’s 7th Framework Programme for research,
technological development and demonstration. The consortium is led by Professor Rutger Ploeg
at the University of Oxford and brings together academic institutions, clinical and scientific experts
as well as small and medium sized enterprises from across Europe to work together on advancing
organ preservation techniques.
Focusing on three clinical trials, two experimental work programmes and the establishment of a
bio-bank, the consortium will be working on improving preservation and reconditioning strategies
for kidneys and livers retrieved for transplantation. By forming collaborations between industry and
academic institutions we aim to introduce organ preservation technologies that will increase the
number and quality of grafts used for transplantation.
LIVER RCT
The multinational randomised controlled liver trial compares the differences in preserving the liver
prior to transplantation using normothermic machine perfusion vs. static cold storage. The trial is led
by Professor Peter Friend at the University of Oxford, and includes four transplant centres in the UK
(Birmingham, Cambridge, King’s College and Royal Free Hospital) as well as Essen in Germany,
Leuven in Belgium and Barcelona in Spain. A total of 260 livers from SCD and ECD donors will be
included in the trial and randomised to either normothermic machine perfusion, using the OrganOx
metra device, or to static cold storage for the duration of their preservation.
The primary outcome measure is the peak serum transaminase level (AST/ALT) within seven days
post-transplant, and secondary measures include graft survival and function, MRCP evidence of
ischaemic cholangiopathy, histological evidence of ischaemia-reperfusion injury as well as health
economic analysis up to one year following transplantation.
POMP RCT
The goal of this randomised, controlled, multi-centre, superiority trial is to compare the effect
of short-term oxygenated hypothermic machine perfusion after static cold storage to static cold
storage alone in transplantation of ECD kidneys donated after brain death.
The study is led by Professor Andreas Paul at the Department of Transplant Surgery at the University
Hospital Essen (Germany) in collaboration with three European Transplant Centres, including
Groningen (Netherlands), Leuven (Belgium) and Oxford (UK) with a total number of 262 kidneys
to be included across all sites. Kidney Assist, the perfusion machine used for pre-implantation
reconditioning is provided by the project partner Organ Assist BV.
The primary outcome measure of this trial is graft survival at one year following transplantation.
Secondary measures include delayed graft function, slow graft function, primary non-function,
biochemical evaluation of kidney function, rejection periods, as well as health economic analysis up
to one year following transplantation.
COMPARE RCT
This trial is designed to investigate whether oxygenated hypothermic machine perfusion is superior
to non-oxygenated hypothermic machine perfusion in improving the function of older DCD kidneys
for transplant. The trial is led by Professor Jacques Pirenne and his team in Leuven (Belgium) and
includes all Belgian transplant centres, Groningen in The Netherlands with all Dutch transplant
centres as well as Oxford in the UK with a large number of experienced British transplant centres.
The study will include a total of 110 kidney pairs that will be randomised to hypothermic machine
perfusion, one with oxygen, and one without. The primary outcome measure for this trial is one year
kidney function with the secondary measures including delayed graft function, primary non function,
graft and patient survival as well as health economic analysis up to one year following transplantation.
Bio-Bank
To investigate the primary and secondary measures of our trials and to ensure future research,
perfusate, blood, urine, bile and tissue samples will be collected during each donor and recipient
transplant procedure to be stored in the COPE bio-bank in Oxford (UK). Lead by Professor
Rutger Ploeg at the University of Oxford, the COPE bio-bank will create the foundation for future
investigative possibilities. Within COPE, Prof Ploeg and his team will focus on identifying novel
biomarkers through a variety of -omics studies including proteomics and metabolomics that will help
predict organ quality and ultimately graft function and survival after transplantation.
Experimental Work
The consortium also focuses on novel approaches in organ preservation using large models to test
the quality of donor livers and kidney in the context of transplantation. The experimental work is led
by Professor Henri Leuvenink at the University of Groningen in the Netherlands and by Professor
Thomas Minor at the University of Bonn in Germany and also involves partners from Poitiers and
Paris in France.
Partners
The COPE Consortium is the official organ preservation task force of the European Society for
Organ Transplantation (ESOT). The Consortium brings together academic institutions, clinical and
scientific experts and SMEs from across Europe.
University of Oxford
University Medical Centre Groningen
University of Duisburg-Essen
University Clinic Bonn
Université Pierre et Marie Curie, Paris VI
Poitiers University, INSERM U1082
University of Leuven
OrganOx Ltd.
Organ Assist Products B.V.
Aqix Ltd.
HEMARINA S.A.
European Society for Organ Transplantation
Med-Assist B.V.
Fundacio Clinic per a la Recerca Biomedica
[email protected]
OPE
ʹΠΟΤΠΣΥΚΦΞ͑ΗΠΣ͑΀ΣΘΒΟ͑
΁ΣΖΤΖΣΧΒΥΚΠΟ͑ΚΟ͑ͶΦΣΠΡΖ
Oxford
Leuven Essen
Paris
Bonn
Poitiers
Barcelona
+44 (0) 1865 226100
Nuffield Department of
Surgical Sciences
Oxford Transplant Centre,
Churchill Hospital
Groningen
www.cope-eu.org
This project has received funding from the
European Union’s Seventh Framework
Programme for research, technological
development and demonstration under
grant agreement no 305934