Reference : Infusion of third party mesenchymal stem cells (MSC) after kidney and liver transplantat...
Scientific congresses and symposiums : Unpublished conference
Human health sciences : Surgery
http://hdl.handle.net/2268/132597
Infusion of third party mesenchymal stem cells (MSC) after kidney and liver transplantation: a phase I-II, open-label, clinical study
English
DETRY, Olivier mailto [Centre Hospitalier Universitaire de Liège - CHU > > Chirurgie abdominale- endocrinienne et de transplantation >]
DELBOUILLE, Marie-Hélène mailto [Centre Hospitalier Universitaire de Liège - CHU > > Chirurgie abdominale- endocrinienne et de transplantation >]
LECHANTEUR, Chantal mailto [Centre Hospitalier Universitaire de Liège - CHU > > Thérapie cellulaire >]
SOMJA, Joan mailto [Centre Hospitalier Universitaire de Liège - CHU > > Anatomie pathologique >]
DE ROOVER, Arnaud mailto [Centre Hospitalier Universitaire de Liège - CHU > > Chirurgie abdominale- endocrinienne et de transplantation >]
WEEKERS, Laurent mailto [Centre Hospitalier Universitaire de Liège - CHU > > Néphrologie >]
DELVENNE, Philippe mailto [Centre Hospitalier Universitaire de Liège - CHU > > Anatomie pathologique >]
BAUDOUX, Etienne mailto [Centre Hospitalier Universitaire de Liège - CHU > > Thérapie cellulaire >]
BEGUIN, Yves mailto [Centre Hospitalier Universitaire de Liège - CHU > > Hématologie clinique >]
19-Oct-2012
Yes
No
International
4th Expert meeting
19-20 octobre 2012
MISOT (MSC in solid organ transplantation)
Barcelona
Spain
[en] tolerance ; cell therapy ; tolerance
[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.
http://hdl.handle.net/2268/132597

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