Objetivo ConceptThe discovery of regulatory T cells (Tregs) has revolutionized our understanding of autoimmune diseases. As T1D is caused by the failure of Tregs to block autoimmune destruction of pancreatic ß-cells, Treg stimulation has the potential to stop the process, preserve ß-cells’ insulin secretion, and likewise prevent or delay disease progression and improve clinical outcome for patients.BackgroundLow-dose interleukin-2 (ld-IL2) was recently shown to stimulate Tregs without stimulating effector T cells. In NOD mice, ld-IL2 can prevent and cure T1D. In humans, (i) we showed that ld-IL2 is safe, induces Tregs and is associated with clinical improvement in patients with autoimmune vasculitis; and (ii) we performed a dose-finding study in T1D to define an ultra-low dose IL-2 (uld-IL2) that is well tolerated and induces Tregs’ numbers and functionality.With this strong background – a well defined mechanism of action; proof of concept in NOD mice; proof of principle in a clinical trial with another autoimmune disease; safety and activity/efficacy data in T1D – we propose a phase-II clinical trial testing the efficacy of uld-IL2 for preserving ß-cells.MethodThis will be a double-blind randomised placebo-controlled, age-stratified (6-35 year), multicentre European trial assessing efficacy and safety of uld-IL2 (0.5M IU/m2/day with a maximum of 1 MIU/m2/day for adult patients) in 138 recently-diagnosed T1D patients. Our methodology strictly follows the Immunology of Diabetes Society consensus recommendations and European regulatory guidelines. The primary end-point is the change from baseline of AUC C-peptide during a mixed meal test at 1 year. The trial is precisely and conservatively powered to detect an effect size of d=0.5.ImpactsIf successful, this trial will have profound impacts for the management of patients with recently-diagnosed T1D, their families and EU economy. It will be a milestone towards preventing T1D in people at risk of this increasingly common childhood disease. Ámbito científico medical and health sciencesclinical medicineendocrinologydiabetesmedical and health sciencesbasic medicineimmunologyautoimmune diseases Programa(s) FP7-HEALTH - Specific Programme "Cooperation": Health Tema(s) HEALTH.2012.2.4.3-2 - Investigator-driven clinical trials for type 1 diabetes research Convocatoria de propuestas FP7-HEALTH-2012-INNOVATION-1 Consulte otros proyectos de esta convocatoria Régimen de financiación CP-FP - Small or medium-scale focused research project Coordinador ASSISTANCE PUBLIQUE HOPITAUX DE PARIS Aportación de la UE € 2 925 549,60 Dirección 55 BOULEVARD DIDEROT 75012 Paris Francia Ver en el mapa Región Ile-de-France Ile-de-France Val-de-Marne Tipo de actividad Research Organisations Contacto administrativo Catherine Tostain Desmares (Ms.) Enlaces Contactar con la organización Opens in new window Sitio web Opens in new window Coste total Sin datos Participantes (6) Ordenar alfabéticamente Ordenar por aportación de la UE Ampliar todo Contraer todo INSERM TRANSFERT SA Francia Aportación de la UE € 310 193,00 Dirección 10 RUE D'ORADOUR-SUR-GLANE - PARISANTE CAMPUS 75015 PARIS Ver en el mapa Región Ile-de-France Ile-de-France Paris Tipo de actividad Private for-profit entities (excluding Higher or Secondary Education Establishments) Contacto administrativo Florence Chung (Dr.) Enlaces Contactar con la organización Opens in new window Sitio web Opens in new window Coste total Sin datos THE CHANCELLOR MASTERS AND SCHOLARS OF THE UNIVERSITY OF CAMBRIDGE La participación finalizó Reino Unido Aportación de la UE € 3 137,96 Dirección TRINITY LANE THE OLD SCHOOLS CB2 1TN Cambridge Ver en el mapa Región East of England East Anglia Cambridgeshire CC Tipo de actividad Higher or Secondary Education Establishments Contacto administrativo Renata Schaeffer (Ms.) Enlaces Contactar con la organización Opens in new window Sitio web Opens in new window Coste total Sin datos UNIVERSITATSSPITAL BASEL Suiza Aportación de la UE € 360 000,00 Dirección HEBELSTRASSE 32 4031 Basel Ver en el mapa Región Schweiz/Suisse/Svizzera Nordwestschweiz Basel-Stadt Tipo de actividad Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Contacto administrativo Marc Donath (Prof.) Enlaces Contactar con la organización Opens in new window Sitio web Opens in new window Coste total Sin datos ILTOO PHARMA Francia Aportación de la UE € 2 040 211,44 Dirección 14 RUE DES RECULETTES 75013 Paris Ver en el mapa Región Ile-de-France Ile-de-France Paris Tipo de actividad Private for-profit entities (excluding Higher or Secondary Education Establishments) Contacto administrativo Jérémie Mariau (Mr.) Enlaces Contactar con la organización Opens in new window Coste total Sin datos DEUTSCHES KREBSFORSCHUNGSZENTRUM HEIDELBERG La participación finalizó Alemania Aportación de la UE € 73 571,20 Dirección IM NEUENHEIMER FELD 280 69120 Heidelberg Ver en el mapa Región Baden-Württemberg Karlsruhe Heidelberg, Stadtkreis Tipo de actividad Research Organisations Contacto administrativo Ina Krischek (Dr.) Enlaces Contactar con la organización Opens in new window Sitio web Opens in new window Coste total Sin datos ACADEMISCH ZIEKENHUIS LEIDEN Países Bajos Aportación de la UE € 187 336,80 Dirección ALBINUSDREEF 2 2333 ZA Leiden Ver en el mapa Región West-Nederland Zuid-Holland Agglomeratie Leiden en Bollenstreek Tipo de actividad Higher or Secondary Education Establishments Contacto administrativo W.M. Schaap (Mr.) Enlaces Contactar con la organización Opens in new window Sitio web Opens in new window Coste total Sin datos