Actively Recruiting
Mesenchymal Stem Cell Infusion as Treatment for Steroid-Resistant Acute Graft Versus Host Disease (GVHD) or Poor Graft Function
Led by University of Liege · Updated on 2024-05-09
100
Participants Needed
12
Research Sites
865 weeks
Total Duration
On this page
Sponsors
U
University of Liege
Lead Sponsor
K
KU Leuven
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Mesenchymal Stem Cell Infusion as Treatment for Steroid-Resistant Acute Graft Versus Host Disease (GVHD) or Poor Graft Function
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female of any age
- Previous allogeneic or autologous hematopoietic stem cell transplantation
- Any source of hematopoietic stem cells and conditioning regimen
- Informed consent given by participant or guardian if minor
- For Part 1: allogeneic transplantation and steroid-refractory grade II-IV acute GVHD
- For Part 1: ongoing therapy with Ciclosporine or Tacrolimus at therapeutic doses
- For Part 1: no new acute GVHD treatment started within 1 month prior to study entry
- For Part 2: allogeneic or autologous transplantation with cytopenia in 2 or 3 blood lineages or severe cytopenia in 1 lineage
- For Part 2: cytopenia lasting at least 2 weeks beyond day 28 after autologous or day 42 (day 60 if cord blood) after allogeneic transplantation
- For Part 2: cytopenia not caused by infection, toxic drugs, renal failure, or other causes
- For Part 2: if HLA-identical related donor with full donor chimerism, only included if donor CD34+ boost failed or is not feasible
- For Part 3: nonmyeloablative allogeneic transplantation
- For Part 3: donor T-cell chimerism less than 50% for 2 consecutive weeks beyond day 21 after transplantation or a 20% decrease with value below 50%
- MSC donors related or unrelated to recipient, male or female, age over 16 years (or no limit if same as stem cell donor)
- MSC donors meet general criteria for hematopoietic stem cell donation and give informed consent
You will not qualify if you...
- HIV positive patients
- Active uncontrolled infection at time of scheduled MSC infusion
- Relapsing or progressing malignancy
- MSC donors who are HIV positive
- MSC donors with known allergy to Lidocaine
- MSC donors (other than stem cell donors) with risk factors for transmissible infectious diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
UZA
Edegem, Antwerpen, Belgium, 2650
Actively Recruiting
2
Hôpital des enfants Reine Fabiola
Brussels, Brabant, Belgium, 1020
Actively Recruiting
3
AZ VUB Jette
Brussels, Brabant, Belgium, 1090
Actively Recruiting
4
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Brussels, Brabant, Belgium, 1200
Actively Recruiting
5
AZ Gasthuisberg Leuven
Leuven, Flamish Brabant, Belgium, 3000
Actively Recruiting
6
UZ Gent
Ghent, Flanders Ost, Belgium, 9000
Actively Recruiting
7
Hôpital de Jolimont
Haine-Saint-Paul, Hainaut, Belgium, 7100
Actively Recruiting
8
Cliniques Universitaires Mont-Godinne
Yvoir, Namur, Belgium, 5530
Actively Recruiting
9
AZ St Jan
Bruges, West Flanders, Belgium, 8000
Actively Recruiting
10
Hôpital Stuyvenberg
Antwerp, Belgium, 2060
Actively Recruiting
11
CHU Sart Tilman
Liège, Belgium, 4000
Actively Recruiting
12
University Hospital Maastricht
Maastricht, Limburg, Netherlands, 6200
Not Yet Recruiting
Research Team
Y
Yves Beguin, MD, PhD
CONTACT
F
Frederic Baron, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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