Development of the Clinical Islet Isolation Process
Research type
Research Study
Full title
Development of the clinical islet isolation process using deceased donor pancreata and isolated islets to improve outcomes of the clinical islet isolation process and increase the number of successful transplantations through the use of novel technologies; investigation into inhibitor molecules for improved pancreas preservation and islet survival and development of functional assays for clinical release.
IRAS ID
333440
Contact name
Gareth Walker
Contact email
Sponsor organisation
Scottish National Blood Transfusion Service
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
Diabetes is a chronic disease resulting from a deficiency in the pancreatic β-cell hormone insulin, largely as result of immune-mediated destruction of the β-cells. Exogenous insulin therapy regulates blood glucose levels but does not prevent episodic hyper- or hypoglycaemia and repeated episodes of hypoglycaemia leads to impaired awareness of hypoglycaemia (IAH). Where IAH is present and medical treatment has been optimised, IAH can only effectively be reversed by pancreas or islet transplantation. Unlike pancreas transplantation, islet transplantation is associated with low morbidity and mortality and may be seen as the preferred treatment.
Islet transplantation in Scotland is a nationally funded (NSD) clinical service carried out in collaboration between the Scottish National Blood Transfusion Service (SNBTS), the Transplant Unit at the Royal Infirmary of Edinburgh and the University of Edinburgh. The production of high-quality islets is crucial to the success of the transplant program, but up to 50% of islet preparations are not used secondary to marginal islet numbers or quality.
Existing islet isolation techniques are becoming increasingly outdated. With the COBE 2991 cell processor (a device currently crucial in the islet isolation process) now being discontinued, new emerging technologies are becoming available which aim to streamline and improve the islet isolation process. SNBTS intend to utilise donor pancreata, non-transplantable isolated islets and digested pancreatic tissue to investigate various novel approaches to optimise the islet isolation process, with the aim of increasing the proportion of successful isolations thus increasing the number of successful islet transplantations.
Consent for use of pancreatic and/or islet tissue for research purposes is obtained during the organ donation process. The consent states that 'organs/tissues can be used in research to improve healthcare in future' as part of approved research projects. This application is to obtain the required ethical approval for use of the organs/tissues for this research study.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
24/PR/0742
Date of REC Opinion
9 Jul 2024
REC opinion
Favourable Opinion