Poster (Scientific congresses and symposiums)
INFUSION OF THIRD-PARTY MESENCHYMAL STEM CELLS (MSC) AFTER KIDNEY AND LIVER TRANSPLANTATION: A PHASE I-II, OPEN-LABEL, CLINICAL STUDY (EudraCT 2011-001822-81 & NCT01429038)
DETRY, Olivier; DELBOUILLE, Marie-Hélène; LECHANTEUR, Chantal et al.
201313eme rencontre de Beaune
 

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Keywords :
stem cell; transplantation; tolerance
Abstract :
[en] MSC cells have demonstrated significant immunosuppressive effects in various in vivo and in vitro studies. This study aims to be the first evaluation of the safety and tolerability of third party MSC infusion after cadaveric kidney and liver transplantation in a prospective phase I-II study, taking advantage of our centre expertise and experience in MSC use in graft-versus-host disease (GVHD) after bone marrow transplantation and using an already functioning GMP-compliant laboratory producing clinical-grade MSC. Secondary end-points will help to evaluate the immunosuppressive potential of MSC after organ transplantation, and the opportunity to develop larger randomised, controlled, phase III trials. After successful transplantation, 10 liver and 10 kidney transplant recipients under standard immunosuppression (tacrolimus, MMF, steroids) will receive an intravenous infusion of 1.5-3x106/kg of third-party MSC on post-operative day 3±2. These patients will be prospectively compared to 10 liver and 10 kidney recipients who meet the inclusion criteria but deny MSC infusion. Safety will be assessed by recording side effects, including opportunistic infections and cancers. Immunosuppressive potential will be evaluated by rejection episode rates, by graft/patient survivals, by immunohistology of 3-months kidney and 6-month liver graft biopsies and by in vitro evaluation of the immunity profile of the recipients. In a second step, reduction (kidney) and progressive weaning (liver) of immunosuppression will be attempted in recipients who received MSC. This ongoing study is supported by research grants from the CHU of Liège, University of Liège, and by the Senior Clinical Research Grant from ESOT. The first patients were included and treated in early 2012, and final results expected in late 2013.
Disciplines :
Surgery
Author, co-author :
DETRY, Olivier  ;  Centre Hospitalier Universitaire de Liège - CHU > Chirurgie abdominale- endocrinienne et de transplantation
DELBOUILLE, Marie-Hélène ;  Centre Hospitalier Universitaire de Liège - CHU > Chirurgie abdominale- endocrinienne et de transplantation
LECHANTEUR, Chantal ;  Centre Hospitalier Universitaire de Liège - CHU > Thérapie cellulaire
SOMJA, Joan ;  Centre Hospitalier Universitaire de Liège - CHU > Anatomie pathologique
DE ROOVER, Arnaud ;  Centre Hospitalier Universitaire de Liège - CHU > Chirurgie abdominale- endocrinienne et de transplantation
WEEKERS, Laurent  ;  Centre Hospitalier Universitaire de Liège - CHU > Néphrologie
SQUIFFLET, Jean-Paul ;  Centre Hospitalier Universitaire de Liège - CHU > Chirurgie abdominale- endocrinienne et de transplantation
Honoré, Pierre ;  Université de Liège - ULiège > Département des sciences cliniques > Chirurgicale abdominale
DELVENNE, Philippe ;  Centre Hospitalier Universitaire de Liège - CHU > Anatomie pathologique
MEURISSE, Michel ;  Centre Hospitalier Universitaire de Liège - CHU > Chirurgie abdominale- endocrinienne et de transplantation
BAUDOUX, Etienne  ;  Centre Hospitalier Universitaire de Liège - CHU > Thérapie cellulaire
BEGUIN, Yves  ;  Centre Hospitalier Universitaire de Liège - CHU > Hématologie clinique
Language :
English
Title :
INFUSION OF THIRD-PARTY MESENCHYMAL STEM CELLS (MSC) AFTER KIDNEY AND LIVER TRANSPLANTATION: A PHASE I-II, OPEN-LABEL, CLINICAL STUDY (EudraCT 2011-001822-81 & NCT01429038)
Publication date :
30 May 2013
Event name :
13eme rencontre de Beaune
Event organizer :
Société Francophone de Transplantation
Event place :
Beaune, France
Event date :
du 30 au 31 mai 2013
Audience :
International
Available on ORBi :
since 07 July 2013

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