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Pharmaceutical Solutions

Fludarabine

Fludarabine phosphate

Efficacy of MSC infusion on one-year overall survival of patients transplanted with HLA-mismatched PBSC.

Patients will receive a conditioning regimen consisting in fludarabine (total dose 90 mg/square meter) and 2 Gy total body irradiation.

MSC cells (1,5-3,0 x 10E6 MSC/Kg BW) will be injected, followed, at least one hour later, by the infusion of HLA-mismatched PBSC from related or unrelated donor.

Patients will receive a conditioning regimen consisting in fludarabine (total dose 90 mg/square meter) and 2Gy total body irradiation.

Isotonic solution will be injected will be injected, followed, at least one hour later, by the infusion of HLA-mismatched PBSC from related or unrelated donor.

Mesenchymal stem cells

Isotonic solution

Yves Beguin, MD, PhD

Frédéric Baron, MD, PhD

Evelyne Willems, MD

Dominik Selleslag, MD, PhD

Pierre Zachée, MD, PhD

Philippe Lewalle, MD, PhD

Dominique Bron, MD, PhD

Wilfried Schroyens, MD, PhD

Chantal Lechanteur, PhD

Etienne Baudoux, MD

Johan Maertens, MD

Rik Schots, MD, PhD

Augustin Ferrant, MD, PhD

Lucien Noens, MD, PhD

Chantal Doyen, MD, PhD

Tessa Kerre, MD, PhD

Carlos Graux, MD, PhD

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.

MSC and HSC Coinfusion in Mismatched Minitransplants

Co-transplantation of Mesenchymal Stem Cells and HLA-mismatched Allogeneic Hematopoietic Cells After Nonmyeloablative Conditioning: a Phase II Randomized Double-blind Study

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