Heparinized Islets in Clinical Islet Transplantation
Recruitment status was Not yet recruiting
In this study the islets will be surface modified to carry immobilised heparin (Corline Heparin Surface) prior to transplantation. The primary objective is to protect the islets from being attacked by the immediate defence systems in blood (coagulation and inflammation), so that a larger portion of the islets will survive the initial phase and engraft. Evaluation will be based on metabolic and blood chemistry parameters, and in some patients also by radioactive labelling of islets and imaging by PET.
Procedure: Transplantation of islets with heparin coating
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open Study to Evaluate Safety and Efficacy of Allogenic Islet Transplantation Using Islets Coated With Immobilised Heparin|
Transplantation of islets of Langerhans isolated from donated organs is a promising therapy for diabetes type 1. The results so far have, however, not met with the expectations due to relatively low efficiency. Even in situations where the patients have become insulin-free, it has been estimated that the transplanted islet mass is less than 25% of the islet mass of a healthy individual, which in many cases has required repeated use of insulin injections. The islets are transferred to the patient by an infusion drop to the liver via the portal vein.
Researches within the Nordic Network for Clinical Islet Transplantation have in a series of publications shown that the islets are subject to a violent immunological reaction that is non-specific with regard to the individual patient (IBMIR) during the initial contact with blood (Moberg et al, Lancet 2002, among several). The IBMIR reaction is in the earliest phase mediated by coagulation and complement reactions.
In this study the islets will be surface modified to carry immobilised heparin (Corline Heparin Surface) prior to transplantation. The primary objective is to protect the islets from being attacked by IBMIR so that a larger portion of the islets will survive the initial phase and engraft. In a recent paper published by the research group (Cabric et. al., Diabetes, May 2007), the beneficial effects of immobilised heparin on the islets to counteract IBMIR were shown by experiments at the lab bench and in experimental animals.
The evaluation of the transplantations in this study will be based on metabolic and blood chemistry parameters, similar to the evaluations of other transplanted patients within the Nordic Network. A limited subgroup of patients will be evaluated by means of radioactive labelling of a portion of the transplanted islets allowing for investigation with PET (positron emission tomography). By this method it is possible to show the distribution of islets in the liver and to assess how the islets will survive the first hours after the infusion (Eich et.al., New England Journal of Medicine, June 28, 2007).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00678990
|Contact: Gunnar Tufveson, Professor||+46 18 firstname.lastname@example.org|
|Department of Transplantation and Liver Surgery, Sahlgrenska University Hospital||Not yet recruiting|
|Göteborg, Sweden, SE-413 45|
|Contact: Marie Felldin, MD +46 31 3427019 email@example.com|
|Principal Investigator: Marie Felldin, MD|
|Department of Nephrology and Transplantation, University Hospital MAS||Not yet recruiting|
|Malmö, Sweden, SE-205 02|
|Contact: Helene Andersson, MD +46 40 331000 firstname.lastname@example.org|
|Principal Investigator: Helene Andersson, MD|
|Department of Transplantation Surgery, Karolinska University Hospital||Not yet recruiting|
|Stockholm, Sweden, SE-141 86|
|Contact: Torbjörn Lundgren, MD +46 73 6994946 email@example.com|
|Principal Investigator: Annika Tibell, Assoc. Prof.|
|Sub-Investigator: Torbjörn Lundgren, MD|
|Department of Transplantation and Liver Surgery, Uppsala University Hospital||Not yet recruiting|
|Uppsala, Sweden, SE-751 85|
|Contact: Gunnar Tufveson, Professor +46 18 6113116 firstname.lastname@example.org|
|Principal Investigator: Gunnar Tufveson, Professor|
|Principal Investigator:||Gunnar Tufveson, Professor||Uppsala University Hospital|