Use of Donor Pancreata and Islets for Islet Isolation Development
Research type
Research Study
Full title
Use of deceased donor pancreata and high and low purity islet tissue to optimise and improve the clinical islet isolation process in a research environment.
IRAS ID
138129
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
7 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 very 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.
In order to optimise our islet isolation techniques, and therefore increase the number of transplantable islet preparations, the SNBTS intends to carry out research isolation procedures from donor pancreata and non-transplantable digested pancreatic tissue. This will allow us to vary isolation parameters, and try different techniques including the use of automated technologies, outwith the pressures of a clinical service. The isolated islets will be used for internal research studies, including the derivation and characterisation of different cell types from pancreatic tissue e.g. mesenchymal stem cells.
Consent for use of pancreatic and/or islet tissue is obtained during the organ donation process. The consent states that 'specified organs and/or samples derived from specific organs: May be stored and used for ethically approved research'. This application is to obtain the required ethical approval for use of the organs/samples in this research.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
17/ES/0079
Date of REC Opinion
22 Jun 2017
REC opinion
Favourable Opinion