NCT00603330

Brief 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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_2

Geographic Reach
2 countries

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 29, 2008

Completed
16.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

16.6 years

First QC Date

January 16, 2008

Last Update Submit

May 8, 2024

Conditions

Graft-versus-host DiseasePoor Graft FunctionLow Donor T-cell Chimerism

Keywords

Mesenchymal stem cellsGraft-versus-host diseasePoor graft functionChimerismHematopoietic cell transplantation recipientsLow donor T-cell chimerism

Outcome Measures

Primary Outcomes (3)

  • Arm 1. Efficacy of MSC infusion as treatment for steroid-resistant grade II - IV acute GVHD.

    30 days

  • Arm 2. Efficacy of MSC infusion as treatment for poor graft function

    180 days

  • Arm 3. Efficacy of MSC infusion followed by donor lymphocyte infusion for preventing graft rejection in patients with low or failing donor T-cell chimerism after allogeneic HCT

    180 days

Secondary Outcomes (1)

  • Toxicity of MSC infusion

    180 days

Study Arms (3)

1

EXPERIMENTAL

MSC infusion for steroid-refractory grade II-IV acute GVHD. In this arm, 4 x 10E6 MSC/Kg BW of the recipient will be injected during the first hour after thawing.

Biological: Mesenchymal stem cells

2

EXPERIMENTAL

MSC infusion for poor graft function. In this arm, 2 x 10E6 MSC/Kg BW of the recipient will be injected during the first hour after thawing.

Biological: Mesenchymal stem cells

3

EXPERIMENTAL

MSC + DLI for poor donor T-cell chimerism after allogeneic HCT. In this arm, 2 x 10E6 MSC/Kg BW of the recipient will be injected during the first hour after thawing.

Biological: Mesenchymal stem cells

Interventions

Mesenchymal stem cellsBIOLOGICAL

Mesenchymal Stem Cell infusion

123

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient eligibility criteria
  • Male or female of any age.
  • Previous allogeneic transplantation (related or unrelated donor, any degree of HLA matching) or autologous transplantation (for part 2 only) of HSC at any time before.
  • Any source of HSC (marrow, PBSC, cord blood) and any conditioning regimen.
  • Informed consent given by donor or his/her guardian if of minor age.
  • Additional criteria for each part of the protocol:
  • Part 1: MSC for steroid-refractory grade II-IV acute GVHD
  • Allogeneic transplantation.
  • Grade II-IV acute GVHD (see appendix A for acute GVHD grading) de novo or following DLI.
  • Acute GVHD refractory to mPDN 2 mg/kg/day or equivalent, defined as
  • progression of GVHD on day 3 after initiation of steroids
  • no improvement of GVHD on day 7 after initiation of steroids
  • absence of complete resolution of acute GVHD on day 14 after initiation of steroids
  • relapse of acute GVHD during or after steroid taper.
  • Ongoing therapy with Ciclosporine or Tacrolimus at therapeutic doses.
  • +24 more criteria

You may not qualify if:

  • HIV positive.
  • Active uncontrolled infection at time of scheduled MSC infusion.
  • Relapsing or progressing malignancy.
  • HIV positive
  • Known allergy to Lidocaine
  • If donor other than HSC donor : any risk factor for transmissible infectious diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

UZA

Edegem, Antwerpen, 2650, Belgium

RECRUITING

Hôpital des enfants Reine Fabiola

Brussels, Brabant, 1020, Belgium

RECRUITING

AZ VUB Jette

Brussels, Brabant, 1090, Belgium

RECRUITING

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brussels, Brabant, 1200, Belgium

RECRUITING

AZ Gasthuisberg Leuven

Leuven, Flamish Brabant, 3000, Belgium

RECRUITING

UZ Gent

Ghent, Flanders Ost, 9000, Belgium

RECRUITING

Hôpital de Jolimont

Haine-Saint-Paul, Hainaut, 7100, Belgium

RECRUITING

Cliniques Universitaires Mont-Godinne

Yvoir, Namur, 5530, Belgium

RECRUITING

AZ St Jan

Bruges, West Flanders, 8000, Belgium

RECRUITING

Hôpital Stuyvenberg

Antwerp, 2060, Belgium

RECRUITING

CHU Sart Tilman

Liège, 4000, Belgium

RECRUITING

University Hospital Maastricht

Maastricht, Limburg, 6200, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Yves Beguin, MD, PhD

    CHU-ULg

    STUDY CHAIR

  • Frédéric Baron, MD, PhD

    CHU-ULg

    STUDY CHAIR

  • Johan Maertens, MD

    KU Leuven

    PRINCIPAL INVESTIGATOR

  • Harry Schouten, MD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

  • Pierre Zachée, MD

    Stuyvenberg Hospital Antwerpen

    PRINCIPAL INVESTIGATOR

  • Zwi Berneman, MD

    UZA Antwerpen

    PRINCIPAL INVESTIGATOR

  • Lucien Noens, MD, PhD

    UZ-Gent

    PRINCIPAL INVESTIGATOR

  • Rick Schots, MD, PhD

    AZ VUB Jette

    PRINCIPAL INVESTIGATOR

  • Dominik Selleslag, MD

    AZ St. Jan Bugge

    PRINCIPAL INVESTIGATOR

  • Augustin Ferrant, MD, PhD

    UCL St. Luc Brussels

    PRINCIPAL INVESTIGATOR

  • Chantal Doyen, MD

    Cliniques Universitaires Mont-Godinne at Yvoir

    PRINCIPAL INVESTIGATOR

  • Nicole Straetmans, MD

    Hôpital de Jolimont at Haine-St-Paul

    PRINCIPAL INVESTIGATOR

  • Nicole Ferster, MD

    Hôpital des enfants Reine Fabiola at Brussels

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yves Beguin, MD, PhD

CONTACT

32-4-366 72 01yves.beguin@chu.ulg.ac.be

Frederic Baron, MD, PhD

CONTACT

32-4-366 72 01F.Baron@ulg.ac.be

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

January 16, 2008

First Posted

January 29, 2008

Study Start

January 1, 2008

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

May 9, 2024

Record last verified: 2024-05

Locations

BE(11)NL(1)