MSC and HSC Coinfusion in Mismatched Minitransplants

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.

Conditions

• Leukemia, Myeloid, Acute
• Leukemia, Lymphoblastic, Acute
• Leukemia, Myelocytic, Chronic
• Myeloproliferative Disorders
• Myelodysplastic Syndromes
• Multiple Myeloma
• Leukemia, Lymphocytic, Chronic
• Hodgkin's Disease
• Lymphoma, Non-Hodgkin

Interventions

BIOLOGICAL

Mesenchymal stem cells

Mesenchymal stem cell injection

OTHER

Isotonic solution

Isotonic solution injection

Sponsors & Collaborators

• AZ Sint-Jan AV

  collaborator OTHER

• Ziekenhuis Netwerk Antwerpen (ZNA)

  collaborator OTHER

• Jules Bordet Institute

  collaborator OTHER

• Universiteit Antwerpen

  collaborator OTHER

• AZ-VUB

  collaborator OTHER

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  collaborator OTHER

• University Hospital, Ghent

  collaborator OTHER

• University of Liege

  lead OTHER

Principal Investigators

• Yves Beguin, MD, PhD · CHU-ULg

• Frédéric Baron, MD, PhD · CHU-ULg

• Evelyne Willems, MD · CHU-ULg

• Dominik Selleslag, MD, PhD · AZ Brugge

• Pierre Zachée, MD, PhD · ZNA Antwerpen

• Philippe Lewalle, MD, PhD · Bordet Institute, Brussels

• Dominique Bron, MD, PhD · Bordet Institute, Brussels

• Wilfried Schroyens, MD, PhD · UZA Antwerpen

• Chantal Lechanteur, PhD · CHU-ULg

• Etienne Baudoux, MD · CHU-ULg

• Johan Maertens, MD · KUL, Leuven

• Rik Schots, MD, PhD · AZ VUB, Brussels

• Augustin Ferrant, MD, PhD · UCL St. LUC, Brussels

• Lucien Noens, MD, PhD · UZG Gent

• Chantal Doyen, MD, PhD · Cliiques Universitaire Mont-Godinne, Yvoir

• Tessa Kerre, MD, PhD · UZA, Antwerpen

• Carlos Graux, MD, PhD · Cliniques Universitaires, Mont-Godinne

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-07-31

Primary Completion

2021-08-31

Completion

2021-08-31

Countries

• Belgium

Study Locations