Mesenchymal Stem Cell Infusion as Treatment for Steroid-Resistant Acute Graft Versus Host Disease (GVHD) or Poor Graft Function

Summary

The present project aims at investigating the role of MSC for the treatment of patients with

Part 1: Steroid-refractory grade II-IV acute GVHD.

Part 2: Poor graft function (PGF)

Part 3: Low or falling donor T-cell chimerism after allogeneic HCT.

This is a multicenter phase II study examining the feasibility and efficacy of this approach.

Conditions

• Graft-versus-host Disease
• Poor Graft Function
• Low Donor T-cell Chimerism

Interventions

BIOLOGICAL

Mesenchymal stem cells

Mesenchymal Stem Cell infusion

Sponsors & Collaborators

• KU Leuven

  collaborator OTHER

• Maastricht University Medical Center

  collaborator OTHER

• Ziekenhuis Netwerk Antwerpen (ZNA)

  collaborator OTHER

• University Hospital, Antwerp

  collaborator OTHER

• University Hospital, Ghent

  collaborator OTHER

• AZ-VUB

  collaborator OTHER

• AZ Sint-Jan AV

  collaborator OTHER

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  collaborator OTHER

• University Hospital of Mont-Godinne

  collaborator OTHER

• Jolimont Hospital Haine Saint Paul

  collaborator UNKNOWN

• Queen Fabiola Children's University Hospital

  collaborator OTHER

• University of Liege

  lead OTHER

Principal Investigators

• Yves Beguin, MD, PhD · CHU-ULg

• Frédéric Baron, MD, PhD · CHU-ULg

• Johan Maertens, MD · KU Leuven

• Harry Schouten, MD · Maastricht University Medical Center

• Pierre Zachée, MD · Stuyvenberg Hospital Antwerpen

• Zwi Berneman, MD · UZA Antwerpen

• Lucien Noens, MD, PhD · UZ-Gent

• Rick Schots, MD, PhD · AZ VUB Jette

• Dominik Selleslag, MD · AZ St. Jan Bugge

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

• Chantal Doyen, MD · Cliniques Universitaires Mont-Godinne at Yvoir

• Nicole Straetmans, MD · Hôpital de Jolimont at Haine-St-Paul

• Nicole Ferster, MD · Hôpital des enfants Reine Fabiola at Brussels

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-01-31

Primary Completion

2024-08-31

Completion

2024-08-31

Countries

• Belgium
• Netherlands

Study Locations