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Treatment of diabetes by islet cell transplantation

Objective

- To conduct a clinical trial on beta cell transplantation in diabetic patients with the purpose of identifying graft and recipient conditions which favour survival of beta cell allograft prepared from donor pancreata.
- To develop alternative sources for beta cell grafts with the purpose of increasing the availability of donor tissue for transplantation in diabetic patients.

The long term goal of the project is to develop a cure for diabetes by implantation of insulin-producing b cells.

The working hypothesis is that successful transplantation of islet beta cells in man requires standardized preparation of purified grafts with selected size, composition and function. The cell biologic properties of the grafts should be adjusted to the metabolic and immunologic status of the recipient. Purified grafts are expected to increase the efficacy of accompanying measures against (auto)immune reactivity.

Human pancreata are procured by 15 European transplantation centres of our network and are shipped, together with blood and donor data, to the central unit in Brussels. Donor organs are processed at the central facility in Brussels, according to international regulations for handling material intended for implantation in man. For each donation, pancreatic and blood samples are taken for morphologic, toxicologic and microbiologic control as well as for storage; genetic, medical and laboratory information of the donor is collected and stored.

Human beta cell isolation proceeds via the methods which have been developed for laboratory animals. The isolated beta cells fulfil all basic requirements of viability and glucose-regulated functions. Each isolated beta cell preparation will be characterized by quality control data which assess the morphologic and functional state of the cells.

A clinical trial is planned to start in 1993. The purpose of this trial is to test the usefulness of purified beta cell grafts which have been composed on the basis of cell biologic parameters. An expert committee will outline protocols for the clinical trial of islet cell grafts, defining patient selection, surgical act, drug treatment, follow-up. This protocol will be submitted to the national and local ethical committees and to the participating centres. Grafts will be distributed from the central unit to the islet cell transplant centres through Eurotransplant/Bio Implant Services. The clinical trial is coordinated by the central unit where data of donors, recipient and grafts are stored.

Funding Scheme

CSC - Cost-sharing contracts

Coordinator

Rijksuniversiteit Leiden
Address
10,Rijnsburgerweg
2300 RC Leiden
Netherlands

Participants (8)

Katholieke Universiteit Leuven
Belgium
Address
49,Herestraat
3000 Leuven
NOVO-NORDISK A/S
Denmark
Address
Niels Steensens Vej 2
2820 Gentoffe
Norges Teknisk-Naturvitenskapelige Universitet
Norway
Address
6-8,
7034 Trondheim
UNIVERSITE DE PARIS VII DENIS DIDEROT
France
Address
Place Jussieu 2
Paris
UPPSALA UNIVERSITY
Sweden
Address
3,Husargatan 3
751 23 Uppsala
Università degli Studi di Catania
Italy
Address
Piazza S. Maria Di Ges
95123 Catania
Università degli Studi di Pisa
Italy
Address
2,Via Paradisa
56100 Pisa
Vrije Universiteit Brussel
Belgium
Address
103,Laarbeeklaan
1090 Bruxelles