Heparinized Islets in Clinical Islet Transplantation

Not Applicable

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Procedure: Transplantation of islets with heparin coating

• Registration Number: NCT00678990
• Lead Sponsor: Corline Biomedical AB

Brief Summary

In this study the islets will be surface modified to carry immobilised heparin (Corline Heparin Conjugate) prior to transplantation. The primary objective is to investigate safety and efficacy of allogeneic islet transplantation using islets coated with immobilised heparin. The modification with heparin has been shown 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.

Detailed Description

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 Conjugate) 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 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.

Study Timeline

• Study First Submitted: 2008-05-14
• Study First Submitted QC: 2008-05-14
• Study First Posted: 2008-05-16
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-07
• Last Update Posted: 2018-12-10
• Study Start: 2019-01
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open, single arm	Transplantation of islets with heparin coating	Transplantation of islets with heparin coating.

Primary Outcome Measures

Name	Time	Method
Safety	105 days	Number of and grade of Serious Adverse events during the first 105 days after transplantation and Adverse events during the first 75 days after transplantation.

Trial Locations

Locations (2)

Department of Transplantation Surgery, Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Department of Transplantation and Liver Surgery, Uppsala University Hospital; 🇸🇪 Uppsala, Sweden