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Graft-versus-host DiseasePhase 2NCT00603330

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

A Phase 2 study testing Mesenchymal stem cells in people with Graft-versus-host Disease and Poor Graft Function, run by University of Liege at 12 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
Mesenchymal stem cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
12 sitesin 2 countries
Study dates
Jan 2008to Aug 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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:
Show all 40Show fewer
  • 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.
  • Patient may have received previously any other form of treatment for acute GVHD, but no new treatment started within 1 month of study entry.
  • Part 2: MSC for poor graft function (PGF)
  • Allogeneic or autologous transplantation.
  • Cytopenia in 2 or 3 lineages:
  • Hb < 8.0 g/dL and reticulocytes < 1%, with or without transfusion
  • Plt < 20,000/µL without transfusion
  • Neutrophils < 500/µL, without G-CSF administration
  • OR severe cytopenia in 1 lineage:
  • RBC transfusion dependent (if autologous transplantation; despite EPO administration if allogeneic transplantation)
  • Plt transfusion dependent
  • Neutrophils < 500/µL despite G-CSF administration
  • Cytopenia duration ≥ 2 weeks beyond day 28 after autologous HCT, or day 42 (day 60 for cord blood transplantation) after allogeneic HCT.
  • Cytopenia is not related to CMV or other infection, myelosuppressive/toxic drugs, renal failure, peripheral cell destruction or other identifiable cause.
  • In case of HLA-identical related donor and full donor chimerism, patient can only be included if a boost of donor CD34+ cells has been unsuccessful or is not feasible.
  • Part 3: MSC + DLI for poor donor T-cell chimerism
  • Nonmyeloablative allogeneic transplantation.
  • Donor T-cell chimerism < 50% for at least 2 consecutive weeks beyond day 21 after HCT OR
  • 20% decrease in donor T-cell chimerism with the second value < 50%.
  • MSC donor inclusion criteria
  • Related to the recipient (sibling, parent or child) or unrelated.
  • Male or female.
  • Age > 16 yrs (no age limit if same as HSC donor).
  • No HLA matching required.
  • Fulfills generally accepted criteria for allogeneic HSC donation.
  • Informed consent given by donor or his/her guardian if of minor age.

Who cannot join

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

Trial locations and contacts

12 sites in 2 countries.

Yves Beguin, MD, PhD contact

32-4-366 72 01

yves.beguin@chu.ulg.ac.be

Frederic Baron, MD, PhD contact

32-4-366 72 01

F.Baron@ulg.ac.be

12 sites in 2 countries

Belgium11 sites, 11 recruiting

  • Hôpital Stuyvenberg

    Antwerp, 2060

    Pierre Zachée, MD, PhD, 32(03)2177111, pierre.zachee@zna.be

    Pierre Zachée, MD, PhD

    Recruiting

  • AZ St Jan

    Bruges, West Flanders, 8000

    Domonik Selleslag, MD, 32 (050) 453060, dominik.selleslag@azbrugge.be

    Dominik Selleslag, MD

    Recruiting

  • Hôpital des enfants Reine Fabiola

    Brussels, Brabant, 1020

    Alice Ferster, MD, 32(02)4773283, alice.ferster@huderf.be

    Alice Ferster, MD

    Recruiting

  • AZ VUB Jette

    Brussels, Brabant, 1090

    Rik Schots, MD, PhD, 32 (02) 4763105, Rik.Schots@uzbrussel.be

    Rick Schots, MD, PhD

    Recruiting

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    Brussels, Brabant, 1200

    Augustin Ferrant, MD, PhD, 32 (02) 7641880, Augustin.Ferrant@uclouvain.be

    Augustin Ferrant, MD, PhD

    Recruiting

  • UZA

    Edegem, Antwerpen, 2650

    Zwi Berneman, MD, PhD, 32(03)8213250, zwi.berneman@uza.be

    Zwi Berneman, MD, PhD

    Recruiting

  • UZ Gent

    Ghent, Flanders Ost, 9000

    Lucien Noens, MD, PhD, 32(09) 332 21 31, Lucien.Noens@Ugent.be

    Lucien Noens, MD, PhD

    Recruiting

  • Hôpital de Jolimont

    Haine-Saint-Paul, Hainaut, 7100

    Nicole Straetmans, MD, 32(064) 235071, nicole.straetmans@scarlet.be

    Nicole Straetmans, MD

    Recruiting

  • AZ Gasthuisberg Leuven

    Leuven, Flamish Brabant, 3000

    Johan Maertens, MD, 32- 16 33 22 11, johan.maertens@uz.kuleuven.ac.be

    Koen Theunissen, MD, 32- 16 33 22 11, koen.theunissen@uz.kuleuven.ac.be

    Recruiting

  • CHU Sart Tilman

    Liège, 4000

    Yves Beguin, MD/PhD, 32-4-366 72 01, yves.beguin@chu.ulg.ac.be

    Frederic Baron, MD/PhD, 32-4-366 72 01, F.Baron@ulg.ac.be

    Recruiting

  • Cliniques Universitaires Mont-Godinne

    Yvoir, Namur, 5530

    Chantal Doyen, MD, 32(081)423831, chantal.doyen@sang.ucl.ac.be

    Chantal Doyen, MD

    Recruiting

Other trials in Belgium

Netherlands1 site, 1 recruiting

  • University Hospital Maastricht

    Maastricht, Limburg, 6200

    Harry Schouten, MD, +31-43-3876543, h.schouten@intmed.unimaas.nl

    Harry Schouten, MD

    Not yet recruiting

Other trials in Netherlands

About this study

Official title: Infusion of Mesenchymal Stem Cells as Treatment for Steroid-Resistant Grade II to IV Acute GVHD or Poor Graft Function: a Multicenter Phase II Study

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.

Read the detailed description

Part 1: complete recruitment Part 2: complete recruitment Part 3: recruiting

Being tested
Mesenchymal stem cells
Keywords
Mesenchymal stem cells, Graft-versus-host disease, Poor graft function, Chimerism, Hematopoietic cell transplantation recipients, Low donor T-cell chimerism
Medical subject headings
Graft vs Host Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mesenchymal stem cellsBiological

    Mesenchymal Stem Cell infusion

Study groups in NCT00603330
Study groupRoleWhat they receive
1ExperimentalMSC 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.
Receives: Biological: Mesenchymal stem cells
2ExperimentalMSC 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.
Receives: Biological: Mesenchymal stem cells
3ExperimentalMSC + 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.
Receives: Biological: Mesenchymal stem cells

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 30 days

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

    Measured: 180 days

  3. 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

    Measured: 180 days

Secondary outcomes (1)

  1. Toxicity of MSC infusion

    Measured: 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2008 (estimated)
  2. Study startJan 2008
  3. Primary completionAug 2024 (estimated)
  4. Study completionAug 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00603330
Sponsor's protocol ID
TJB0703P1
Status last verified
May 2024
First submitted
16 Jan 2008
Last updated
9 May 2024
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mesenchymal stem cells in people with Graft-versus-host Disease and Poor Graft Function, run by University of Liege at 12 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 40 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yves Beguin, MD, PhD (32-4-366 72 01, yves.beguin@chu.ulg.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Arm 1. Efficacy of MSC infusion as treatment for steroid-resistant grade II - IV acute GVHD. (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00603330.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.

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