Mesenchymal Stem Cell Infusion as Treatment for Steroid-Resistant Acute Graft Versus Host Disease (GVHD) or Poor Graft Function
NCT ID: NCT00603330
Last Updated: 2024-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2008-01-31
2024-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Treatment of Steroid Resistant GVHD by Infusion MSC
NCT00827398
Efficacy and Safety of Adult Human Mesenchymal Stem Cells to Treat Steroid Refractory Acute Graft Versus Host Disease (GVHD)
NCT00366145
Treatment of Refractory Acute Graft-Versus-Host Disease by Sequential Infusion of Allogenic Mesenchymal Stem Cell.
NCT01956903
Safety and Efficacy Study of Adult Human Mesenchymal Stem Cells to Treat Acute Graft Versus Host Disease (GVHD)
NCT00136903
Treatment of Refractory (Acute or Chronic) Graft-Versus-Host Disease by the Infusion of Expanded in-Vitro Allogenic Mesenchymal Stem Cell
NCT00447460
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
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.
Mesenchymal stem cells
Mesenchymal Stem Cell infusion
2
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.
Mesenchymal stem cells
Mesenchymal Stem Cell infusion
3
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.
Mesenchymal stem cells
Mesenchymal Stem Cell infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mesenchymal stem cells
Mesenchymal Stem Cell infusion
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Male or female of any age.
2. 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.
3. Any source of HSC (marrow, PBSC, cord blood) and any conditioning regimen.
4. Informed consent given by donor or his/her guardian if of minor age.
5. Additional criteria for each part of the protocol:
Part 1: MSC for steroid-refractory grade II-IV acute GVHD
1. Allogeneic transplantation.
2. Grade II-IV acute GVHD (see appendix A for acute GVHD grading) de novo or following DLI.
3. 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.
4. Ongoing therapy with Ciclosporine or Tacrolimus at therapeutic doses.
5. 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)
1. Allogeneic or autologous transplantation.
2. 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
3. Cytopenia duration ≥ 2 weeks beyond day 28 after autologous HCT, or day 42 (day 60 for cord blood transplantation) after allogeneic HCT.
4. Cytopenia is not related to CMV or other infection, myelosuppressive/toxic drugs, renal failure, peripheral cell destruction or other identifiable cause.
5. 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
1. Nonmyeloablative allogeneic transplantation.
2. 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%.
1. Related to the recipient (sibling, parent or child) or unrelated.
2. Male or female.
3. Age \> 16 yrs (no age limit if same as HSC donor).
4. No HLA matching required.
5. Fulfills generally accepted criteria for allogeneic HSC donation.
6. Informed consent given by donor or his/her guardian if of minor age.
Exclusion Criteria
2. Active uncontrolled infection at time of scheduled MSC infusion.
3. Relapsing or progressing malignancy.
1. HIV positive
2. Known allergy to Lidocaine
3. If donor other than HSC donor : any risk factor for transmissible infectious diseases.
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
KU Leuven
OTHER
Maastricht University Medical Center
OTHER
Ziekenhuis Netwerk Antwerpen (ZNA)
OTHER
University Hospital, Antwerp
OTHER
University Hospital, Ghent
OTHER
AZ-VUB
OTHER
AZ Sint-Jan AV
OTHER
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
OTHER
University Hospital of Mont-Godinne
OTHER
Jolimont Hospital Haine Saint Paul
UNKNOWN
Queen Fabiola Children's University Hospital
OTHER
University of Liege
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Yves Beguin
Prof
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yves Beguin, MD, PhD
Role: STUDY_CHAIR
CHU-ULg
Frédéric Baron, MD, PhD
Role: STUDY_CHAIR
CHU-ULg
Johan Maertens, MD
Role: PRINCIPAL_INVESTIGATOR
KU Leuven
Harry Schouten, MD
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Center
Pierre Zachée, MD
Role: PRINCIPAL_INVESTIGATOR
Stuyvenberg Hospital Antwerpen
Zwi Berneman, MD
Role: PRINCIPAL_INVESTIGATOR
UZA Antwerpen
Lucien Noens, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UZ-Gent
Rick Schots, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
AZ VUB Jette
Dominik Selleslag, MD
Role: PRINCIPAL_INVESTIGATOR
AZ St. Jan Bugge
Augustin Ferrant, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UCL St. Luc Brussels
Chantal Doyen, MD
Role: PRINCIPAL_INVESTIGATOR
Cliniques Universitaires Mont-Godinne at Yvoir
Nicole Straetmans, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital de Jolimont at Haine-St-Paul
Nicole Ferster, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital des enfants Reine Fabiola at Brussels
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UZA
Edegem, Antwerpen, Belgium
Hôpital des enfants Reine Fabiola
Brussels, Brabant, Belgium
AZ VUB Jette
Brussels, Brabant, Belgium
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Brussels, Brabant, Belgium
AZ Gasthuisberg Leuven
Leuven, Flamish Brabant, Belgium
UZ Gent
Ghent, Flanders Ost, Belgium
Hôpital de Jolimont
Haine-Saint-Paul, Hainaut, Belgium
Cliniques Universitaires Mont-Godinne
Yvoir, Namur, Belgium
AZ St Jan
Bruges, West Flanders, Belgium
Hôpital Stuyvenberg
Antwerp, , Belgium
CHU Sart Tilman
Liège, , Belgium
University Hospital Maastricht
Maastricht, Limburg, Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TJB0703P1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.