Spots Global Cancer Trial Database for MSC and HSC Coinfusion in Mismatched Minitransplants
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Trial Identification
Brief Title: MSC and HSC Coinfusion in Mismatched Minitransplants
Official Title: Co-transplantation of Mesenchymal Stem Cells and HLA-mismatched Allogeneic Hematopoietic Cells After Nonmyeloablative Conditioning: a Phase II Randomized Double-blind Study
Study ID: NCT01045382
Study Description
Brief Summary: The present project aims at evaluating the capacity of MSC to improve one-year overall survival of patients transplanted with HLA-mismatched PBSC from related or unrelated donors after non-myeloablative conditioning. Co-infusion of MSC has been shown to facilitate engraftment of hematopoietic stem cell (HSC) in an immunodeficient mouse model. In addition, it has been shown that infusion of third party MSC in HSC transplantation could be successfully used as treatment for grade II-IV steroid-refractory acute graft versus host disease. One hundred and twenty patients with HLA-mismatched donors will be included over 6 years at multiple centers across Belgium through the transplant committee of the Belgian Hematological Society. The conditioning regimen will consist of fludarabine and 2 Gy TBI, followed by the infusion of donor HSC. Patients will be randomized 1/1 in double-blind fashion to receive or not MSC (1.5-.3.0 x106/kg) from third-party (either haploidentical family members or unrelated volunteer) donors on day 0. Postgrafting immunosuppression will combine tacrolimus and MMF. Except for the collection, expansion and infusion of MSC, the clinical management of the patient will not differ from that of routine NM-HCT.
Detailed Description:
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UZA, Edeghem, Antwerpen, Belgium
St-Luc UCL, Brussels, Brabant, Belgium
AZ Gasthuisberg Leuven, Leuven, Flamish Brabant, Belgium
UZ Gent, Gent, Flanders Ost, Belgium
AZ St-Jan, Brugge, Flanders West, Belgium
Cliniques Universitaires Mont-Godinne, Yvoir, Namur, Belgium
Hôpital Stuyvenberg, Antwerpen, , Belgium
Bordet Institute, Brussels, , Belgium
Vrije Universiteit Brussel, Brussels, , Belgium
CHU-ULg, Liège, , Belgium
Contact Details
Name: Yves Beguin, MD, PhD
Affiliation: CHU-ULg
Role: PRINCIPAL_INVESTIGATOR
Name: Frédéric Baron, MD, PhD
Affiliation: CHU-ULg
Role: STUDY_CHAIR
Name: Evelyne Willems, MD
Affiliation: CHU-ULg
Role: PRINCIPAL_INVESTIGATOR
Name: Dominik Selleslag, MD, PhD
Affiliation: AZ Brugge
Role: PRINCIPAL_INVESTIGATOR
Name: Pierre Zachée, MD, PhD
Affiliation: ZNA Antwerpen
Role: PRINCIPAL_INVESTIGATOR
Name: Philippe Lewalle, MD, PhD
Affiliation: Bordet Institute, Brussels
Role: PRINCIPAL_INVESTIGATOR
Name: Dominique Bron, MD, PhD
Affiliation: Bordet Institute, Brussels
Role: PRINCIPAL_INVESTIGATOR
Name: Wilfried Schroyens, MD, PhD
Affiliation: UZA Antwerpen
Role: PRINCIPAL_INVESTIGATOR
Name: Chantal Lechanteur, PhD
Affiliation: CHU-ULg
Role: PRINCIPAL_INVESTIGATOR
Name: Etienne Baudoux, MD
Affiliation: CHU-ULg
Role: PRINCIPAL_INVESTIGATOR
Name: Johan Maertens, MD
Affiliation: KUL, Leuven
Role: PRINCIPAL_INVESTIGATOR
Name: Rik Schots, MD, PhD
Affiliation: AZ VUB, Brussels
Role: PRINCIPAL_INVESTIGATOR
Name: Augustin Ferrant, MD, PhD
Affiliation: UCL St. LUC, Brussels
Role: PRINCIPAL_INVESTIGATOR
Name: Lucien Noens, MD, PhD
Affiliation: UZG Gent
Role: PRINCIPAL_INVESTIGATOR
Name: Chantal Doyen, MD, PhD
Affiliation: Cliiques Universitaire Mont-Godinne, Yvoir
Role: PRINCIPAL_INVESTIGATOR
Name: Tessa Kerre, MD, PhD
Affiliation: UZA, Antwerpen
Role: PRINCIPAL_INVESTIGATOR
Name: Carlos Graux, MD, PhD
Affiliation: Cliniques Universitaires, Mont-Godinne
Role: PRINCIPAL_INVESTIGATOR
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