Improving transplant outcomes by novel organ preservation protocols.
Research type
Research Study
Full title
Improving Transplantation outcomes by investigation of novel methods of organ procurement, preservation and reconditioning.
IRAS ID
182637
Contact name
Andrew Fisher
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
BH149192,
Duration of Study in the UK
4 years, 11 months, 30 days
Research summary
The objective of the study is: 'to develop and evaluate novel approaches and technologies that increase the availability of suitable donor organs for transplantation, while improving graft survival'. Due to the large scope for this project; spanning the breadth of organ transplantation (heart, lungs, kidney, liver and pancreas); it is expected that a wide variety of perfusion and preservation techniques will be assessed for efficacy suitable to each organ system. Techniques investigated will include the present clinical standard of care, emerging techniques, as well as techniques which may emerge during the study. It is expected that these techniques will include but not be limited to:
• Hypothermic machine perfusion (with and without oxygenation)
o Used for kidney preservation; particularly for extended criteria or DCD donation. It has been investigated in kidney, pancreas, liver, and heart.
• Normothermic perfusion (for long and short periods and possibly with packed red cells)
o Recently emerged as the focus of a number of clinical trials for preservation or reconditioning of kidney, heart, lungs, and liver with investigations ongoing in other organs.
• Gaseous oxygen perfusion (persufflation).
o Investigated in a variety of implementations including kidney, pancreas, liver, heart, as well as small bowel and composite tissue preservation. Several clinical trials including liver and pancreas.
• Static cold preservation (control).
o The traditional clinical standard of care for all organs. This will be implemented as a control for our studies.There may be multiple sets of equipment designed to incorporate features specific to the requirements of the tissues under consideration in an effort to establish best practices for each individual tissue. In addition any of these techniques may be investigated in parallel with a number of advanced therapeutics for tissue repair; such as emerging pharmaceutical drugs or cellular therapies which may further benefit organ health.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
16/NE/0230
Date of REC Opinion
17 Aug 2016
REC opinion
Favourable Opinion