Activities and Achievements

THE FINAL RISET MEETING

 

As part of the dissemination and training activities which RISET undertook, and as a means of communicating some of the final findings of the project, a symposium was held on 22nd June 2010 in the European Parliament in Brussels.  This was attended by approximately 90 people including partners from all over Europe, invited guests, representatives of the European Commission and young trainees who received training awards to enable them to attend the meeting.  Two leaflets were published to highlight some of the work undertaken on the key themes of the European Commission;  " Co-operating to improve the Health of EU Citizens - The RISET Project" and " Improving the Health of EU Citizens - How the RISET project will benefit transplant patients".

To read the leaflets click on the links below:

Leaflet - How the RISET project will benefit transplant patients

Leaflet - Co-operation; the RISET project 

 

FINAL REPORT

 

A final report was written and submitted to the European Commission detailing the work and achievements of the project.

To read the final report click on the link below:

RISET Final Report

 

ACHIEVEMENTS

 

Some of the achievements to date have been:   (for full information see the Final Report)

  • Important steps towards achieving transplantation tolerance by investigating innovative therapies
  • 530 patients included in RISET clinical studies
  • 4,268 samples exchanged among RISET partners (at June 2010)
  • Results obtained from the clinical studies provided important clues on the:    

clinical conditions for complete drug weaning in liver transplant recipients           

clinical conditions for minimisation of immunosuppression (monotherapy) in kidney transplant recipients                                                                                      

identification of potentially relevant biomarkers to guide weaning or minimization   

establishment of a critical mass of data to set up future clinical studies       

  • Biomarker tests developed and validated for novel diagnostics to identify patients for safe mnimization or withdrawal of immunosuppression.
  • Tests for commercial development in collaboration with the industry -  facilitating   personalized medicine in clinical transplantation.
  • Identified biomarkers which enable the development of guidelines for drug minimization.
  • Microarray experiments for clinical studies.
  • 1,063 clinical samples processed for microarray
  • 77 experimental samples processed for microarray
  • A series of publications with the academic and clinical RISET partners
  • Patent application  (Biomarkers of tolerance in kidney transplant recipients)
  • Identification of new genes and molecules relevant for the induction of transplantation tolerance
  • Standard Operating Procedures (SOPs) on sample preparation and assay performance
  • A tool enabling sample tracking on the RISET website for the management of multicentre clinical studies
  • A Data Repository developed to store clinical data and immunomonitoring results - This Data Repository is a unique resource on the follow-up of patients in tolerance investigation studies.
  • Analysis of a common set of tolerance genes in different animal models 
  • Ethical recommendations providing guidelines on pilot clinical studies for tolerance induction
  • The RISET ethics team linked up with the regulatory authorities and acknowledged as an interested party by the Committee for Advanced Cell Therapies
  • Development of the understanding of the way transplanted patients and the general public perceive tolerance induction
  • Exploitable knowledge developed including description of results, perspectives and potential commercial applications
  • Large basic research / clinical meetings and training events held:                       

March 2007,  Madrid; Molecular Signatures in Transplantation Tolerance             

March 2008, London; Biomarkers in Transplantation (with ITN)                       

March 2009, Belgium; Transplantation Tolerance:Update on Clinical Trials and  Biomarkers (with ITN)

PUBLICATIONS

 

A comprehensive list of the publications arising from the research undertaken on the project has also been published.  This includes over 160 publications in peer reviewed journals - many of which are joint publications between partners across Europe - contributions to several book chapters and various reviews. 

To see the complete list of publications click on the link below:

RISET publications list

 

POSTERS

 

Several posters on the Project were presented at EFI 2008 and 2009: Poster picture - new EU directive  

New EU Directive Proposed for Quality and Safety of Organ Transplantation

A. MAHALATCHIMY* and A. CAMBON-THOMSEN 

To see the poster, click on the link below:

Poster - New EU directive proposed ...

 

The new regulation on advanced therapy medicinal products in EU law: What are the main contributions?
Regulation (EC) No 1394/2007 on advanced therapy medicinal products,
amending directive 2001/83/EC and Regulation(EC) No 726/2004
A. MAHALATCHIMY et  E. RIAL-SEBBAG, N. VALDEYRON, F. TABOULET, A. CAMBON-THOMSEN

To see the poster, click on the link below:

Poster - The new regulations on advanced therapy medicinal products

Poster picture - RISET 

Harmonising the Legal Framework for the Use of Human Cells in Therapy in Europe didn’t we forget something about Ethics?
Emmanuelle Rial-Sebbag, Aurélie Mahalatchimy, Anne-Marie Duguet, Anne Cambon-Thomsen

To see the poster, click on the link below:

Poster - Harmonising the legal framework 

 

European Regulation in transplantation and related therapies: recent

developments at European level
Anne Cambon-Thomsen, Virginie Commin

To see the poster, click on the link below:

Poster - European regulations in transplantation related therapies

 Poster picture - State of public debate

Recommendations proposed by an EU consortium regarding ethical aspects of pilot clinical assays for tolerance induction in transplantation
V. Commin, A. Cambon-Thomsen

To see the poster, click on the link below:

Poster - Recommendations proposed by an EU consortium

 
Immunosuppression and Tolerance Induction in Human Transplantations; state of the public debate

Christiane Kapitz, Anne Cambon-Thomsen

To see the poster, click on the link below:

Poster - Immunosuppression and tol induction - state of pub debate 

 

Reprogramming the Immune System for the Establishment of Tolerance
Monica Dolton, Kathryn Wood

To see the poster, click on the link below:

Poster - RISET mdkjw