Projects
Pancreatic Islets
A Sustainable Quality-Assured System for Assessment of Pancreatic Islets for Product Release and Transport to Geographically Distant Clinical Transplant Centres
Lead N8 Academic: Professor Jim Shaw, Newcastle
Universities of Newcastle and Leeds, Labman Automation Ltd, Complement Genomics Ltd, LGC Ltd
Pancreatic islet transplantation is a surgical intervention used to treat patients with uncontrolled type 1 diabetes. The islet transplantation programme in the UK is funded by the NHS in a ‘hub and spoke’ model where islets are isolated from donor pancreas at one site and transported to a geographically distant site for transplant. However, the transport chamber has not been optimised and there are no validated quality assurance (QA) tests that can indicate quality of the islets. There is therefore a need for an investigation of critical transport parameters, the design of a new controlled transport unit and development of QA tests that can be carried out in an external accredited laboratory.
New QA tests will be developed using a variety of methods including molecular biology, biochemistry and imaging. A novel transport system has been invented by the applicants offering regular, non-traumatic, medium exchange that removes cell debris, pro-inflammatory cytokines and toxins.
This is a unique collaboration between N8 University Medical and Business Schools, the NHS and the private sector involving:
· Newcastle University
· Leeds University
· Complement Genomics Ltd
· LGC Ltd
· Labman Automation Ltd
The project is led by Prof James Shaw (Newcastle University), who is Chair of the UK Islet Transplant Consortium.
The Aims:
The project aims to improve quality assurance for islet transplantation to improve clinical outcome and enable the use of more marginal donor organs. Truly predictive pre-transplant assessment will enable appropriate selection and successful transplantation of islets purified from a wider pool of donors including the increasing number of non-heart-beating donors. The robust transport protocols and new transport unit will allow equitable nationwide access to the islet transplantation programme regardless of location.
The Benefits of the Collaboration:
The impact of this research will be improved outcomes for patients (in some cases 100% insulin independence at 5 years) and a reduction in the cost to the NHS/society of a patient with uncontrolled diabetes. QA tests that can demonstrate safety, identify, purify, viability and potency are required for full regulatory compliance and will ensure the ongoing success of the programme in the UK and elsewhere. Benefits to the industrial partners in this consortium include the provision of services (such as QA testing) and products (such as transport components). This RegeNer8 initiative has enabled development of a unique new consortium bringing together a team from a range of disciplines with complementary skills. This includes commercial partners from accredited laboratories, vital to establishing robust external QA, rectifying the current unacceptable unregulated system in academia.
