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Infusion of third-party mesenchymal stream cells after liver transplantation: a phase-1, open-label, clinical study
DETRY, Olivier; VANDERMEULEN, Morgan; DELBOUILLE, Marie-Hélène et al.
2015In Acta Gastro-Enterologica Belgica, 78 (1), p. 29
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Abstract :
[en] Background: Mesenchymal stromal cells (MSC) are multipotent bone marrow progenitors that have demonstrated significant immunosuppressive effects in various in vivo and in vitro studies. This study aimed to be the first evaluation of the safety and tolerability of MSC infusion after liver transplantation in a prospective, controlled phase-1 study. This study aimed to be the first evaluation of the safety and tolerability of MSC infusion after liver transplantation in a prospective, controlled phase-1 study. Patients & Methods: Clinical grade MSCs were locally collected from the bone marrow of unrelated healthy donors. They were cultured in a GMP-compliant lab, underwent extensive quality controls and were frozen for storage in a MSC bank. When needed for patient treatment, MSC were thawed and intravenously injected into patients. 10 liver transplant recipients under standard immunosuppression (TAC-MMF-low dose steroids until day 30) received 1.5-3x106/kg MSC on post-operative day 3±2. These patients were prospectively compared to a group of 10 control (MSC-) liver recipients. Primary endpoints were MSC infusion toxicity, and incidence of cancer and opportunistic infections at month 6. Secondary endpoints were patient and graft survivals and rejection at month 6, as well as the effects of MSC on recipients’ immune function and on immunohistology of at month 6 graft biopsies. Results: No MSC infusional toxicity was observed. Both groups were comparable in terms of donor and recipient characteristics. There was no difference in primary end-points between control and MSC groups. No patient developed de novo cancer. There was no statistical difference in patient and graft survivals or in rejection rates. There was no graft rejection in the MSC group. Month-6 graft biopsies were not different according to Banff and fibrosis scores. Discussion: This phase 1 study showed excellent tolerability and safety of a single infusion of third-party MSC after liver transplantation. There were no graft safety issues and no excess of immunosuppression after MSC injection. Further analyses of consequences of MSC injection on the immune profile are needed. The possibility of avoiding calcineurin-inhibitors with repeated MSC injections as main immunosuppressive therapy and/of tolerance induction by MSC infusion should be investigated by further studies.
Disciplines :
Gastroenterology & hepatology
Surgery
Author, co-author :
DETRY, Olivier  ;  Centre Hospitalier Universitaire de Liège - CHU > Chirurgie abdominale- endocrinienne et de transplantation
VANDERMEULEN, Morgan ;  Centre Hospitalier Universitaire de Liège - CHU > Frais communs chirurgie
DELBOUILLE, Marie-Hélène ;  Centre Hospitalier Universitaire de Liège - CHU > Chirurgie abdominale- endocrinienne et de transplantation
DE ROOVER, Arnaud ;  Centre Hospitalier Universitaire de Liège - CHU > Chirurgie abdominale- endocrinienne et de transplantation
SOMJA, Joan ;  Centre Hospitalier Universitaire de Liège - CHU > Anatomie pathologique
BLETARD, Noëlla ;  Centre Hospitalier Universitaire de Liège - CHU > Anatomie pathologique
BRIQUET, Alexandra ;  Centre Hospitalier Universitaire de Liège - CHU > Centre d'oncologie
LECHANTEUR, Chantal ;  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 stream cells after liver transplantation: a phase-1, open-label, clinical study
Publication date :
March 2015
Event name :
XXVIIth Belgian Week of Gastroenterology
Event organizer :
Société Royale Belge de Gastroentérologie
Event place :
Brussels, Belgium
Event date :
du 25 au 28 février 2015
Journal title :
Acta Gastro-Enterologica Belgica
ISSN :
0001-5644
eISSN :
1784-3227
Publisher :
Acta Medica Belgica, Bruxelles, Belgium
Volume :
78
Issue :
1
Pages :
A29
Peer reviewed :
Peer Reviewed verified by ORBi
Available on ORBi :
since 02 April 2015

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