Ex vivo normothermic perfusion (EVNP) of kidneys for tranplantation.
Research type
Research Study
Full title
Establishing ex vivo normothermic perfusion (EVNP) of kidneys for transplantation
IRAS ID
167410
Contact name
Avinash Sewpaul
Contact email
Sponsor organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
14PL000030, Newcastle University Legal liability for design
Duration of Study in the UK
1 years, 9 months, 4 days
Research summary
Transplantation remains the gold standard renal replacement therapy, but waiting lists have continued to grow.Over the last five years the number of cadaveric donors has increased significantly (50%): but the majority of these “extra” donors are either extended criteria (ECD) and/or donors after cardiac death (DCD) with prolonged warm ischaemic times. In 2012-2013 34% of donors were over 60 (16% 10 years ago) and nearly 40% were DCD (<5% in 2003/4). Delayed graft function (DGF) has been shown to not only adversely affect early post transplant outcomes, but also long term graft survival.
Research into organ preservation and graft ischaemia-reperfusion injury has become highly active with the increased use of DCD and ECD organs and the associated high rate of DGF.
Based on the initial work by Professoor M Nicholson and his team who iniatilly performed ex-vivo normothermic perfusion (EVNP) of human kidneys (which has shown significant promise to reduce DGF in recipients of ECD kidneys) we have developed an EVNP device using standard cardiopulmonary bypass equipment and a red cell based solution. We like to think of it as "ECMO for the poorly kidney".
The EVNP machine offers several advantages:
1. Assessment of marginal kidneys
2. Reconditioning of DCD kidneys (to reduce the incidence of delayed graft function)
3. As a platform for drug deliveryWhilst we know that Initially we intend to use To perform EVNP using 12 “discarded” human kidneys to see if we can replicate the results of the Leicester group. We also would like to understand the cellular/molecular processes that happen and are responsible for reconditioning kidneys and measure the levels of biomarkers of kidney injury such as micro RNA.
These kidneys will not be used for transplantation.
We however are hopeful that the valuable data and experience collected in this initial phase will eventually lead to the establishment of EVNP for kidney transplantationREC name
South Central - Oxford C Research Ethics Committee
REC reference
15/SC/0161
Date of REC Opinion
12 Mar 2015
REC opinion
Favourable Opinion