Objectif - 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. Champ scientifique medical and health sciencesclinical medicineendocrinologydiabetesmedical and health sciencesclinical medicinetransplantation Programme(s) FP4-BIOMED 2 - Specific research, technological development and demonstration programme in the field of biomedicine and health, 1994-1998 Thème(s) 4.4.2 - Insulin and non-insulin diabetes Appel à propositions Data not available Régime de financement CSC - Cost-sharing contracts Coordinateur Rijksuniversiteit Leiden Contribution de l’UE Aucune donnée Adresse 10,Rijnsburgerweg 2300 RC Leiden Pays-Bas Voir sur la carte Coût total Aucune donnée Participants (8) Trier par ordre alphabétique Trier par contribution de l’UE Tout développer Tout réduire Katholieke Universiteit Leuven Belgique Contribution de l’UE Aucune donnée Adresse 49,Herestraat 3000 Leuven Voir sur la carte Coût total Aucune donnée NOVO-NORDISK A/S Danemark Contribution de l’UE Aucune donnée Adresse Niels Steensens Vej 2 2820 GENTOFFE Voir sur la carte Coût total Aucune donnée Norges Teknisk-Naturvitenskapelige Universitet Norvège Contribution de l’UE Aucune donnée Adresse 6-8, 7034 Trondheim Voir sur la carte Coût total Aucune donnée UNIVERSITE DE PARIS VII DENIS DIDEROT France Contribution de l’UE Aucune donnée Adresse Place Jussieu 2 PARIS Voir sur la carte Coût total Aucune donnée UPPSALA UNIVERSITY Suède Contribution de l’UE Aucune donnée Adresse 3,Husargatan 3 751 23 UPPSALA Voir sur la carte Coût total Aucune donnée Università degli Studi di Catania Italie Contribution de l’UE Aucune donnée Adresse Piazza S. Maria di Ges 95123 Catania Voir sur la carte Coût total Aucune donnée Università degli Studi di Pisa Italie Contribution de l’UE Aucune donnée Adresse 2,Via Paradisa 56100 Pisa Voir sur la carte Coût total Aucune donnée Vrije Universiteit Brussel Belgique Contribution de l’UE Aucune donnée Adresse 103,Laarbeeklaan 1090 Bruxelles Voir sur la carte Coût total Aucune donnée
