Actively Recruiting
Treatment Of Steroid-Refractory Acute Graft-versus-host Disease With Mesenchymal Stromal Cells Versus Best Available Therapy
Led by medac GmbH · Updated on 2025-08-13
210
Participants Needed
42
Research Sites
467 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary purpose of this trial is to demonstrate the superiority of MC0518 compared to the first used best available therapy (BAT) with respect to overall response rate (ORR) at Day 28 and/or overall survival (OS) until Visit Month 24 in adult and adolescent subjects with steroid-refractory acute graft-versus-host disease (SR-aGvHD).
CONDITIONS
Official Title
Treatment Of Steroid-Refractory Acute Graft-versus-host Disease With Mesenchymal Stromal Cells Versus Best Available Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant had a previous allogeneic HSCT for non-malignant or haematological malignant disease
- Clinically diagnosed with Grade II to IV acute graft-versus-host disease at screening
- Experienced failure of first-line treatment with steroids for aGvHD as defined by progression, no improvement, or incomplete response
- Estimated life expectancy greater than 28 days at screening
- Male or female participant aged 12 years or older at screening
You will not qualify if you...
- Overt relapse, progression, or persistence of underlying disease at screening
- Last HSCT was for a solid tumor disease
- Presence of graft-versus-host disease overlap syndrome at screening
- Received systemic first-line treatment for aGvHD other than steroids and specified prophylaxis before screening
- Known pregnancy or breastfeeding at screening
- Received investigational treatment within 30 days or 5 half-lives before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 42 locations
1
Centre Hospitalier Universitaire (CHU) Amiens-Picardie - Hopital Sud
Amiens, France, 80054
Actively Recruiting
2
CHU Jean Minjoz
Besançon, France, 25030
Actively Recruiting
3
Hopital Michallon
Grenoble, France, 38700
Actively Recruiting
4
CHRU Lille- Hopital Claude Huriez
Lille, France, 59000
Actively Recruiting
5
CHU de Nantes - Hotel Dieu
Nantes, France, 44093
Actively Recruiting
6
CHU de Nice Hopital Archet 1
Nice, France, 06200
Actively Recruiting
7
Centre Hospitalier Lyon Sud Pavillon Marcel Berard 1G
Pierre-Bénite, France, 69630
Actively Recruiting
8
Centre Hospitalier Universitaire CHU de Toulouse
Toulouse, France, 31059
Actively Recruiting
9
Hopitaux De Brabois
Vandœuvre-lès-Nancy, France, 54511
Actively Recruiting
10
Klinikum rechts der Isar
Munich, Bavaria, Germany, 81675
Actively Recruiting
11
Universitaetsklinikum Wuerzburg - Medizinische Klinik und Poliklinik II - Zentrum fuer Allogene Blutstammzelltransplantation
Würzburg, Bavaria, Germany, 97080
Actively Recruiting
12
Klinikum der Johann Wolfgang Goethe-Universitaet - Frankfurt am Main
Frankfurt am Main, Hesse, Germany, 60590
Actively Recruiting
13
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany, 30625
Actively Recruiting
14
Uniklinik Koeln
Cologne, North Rhine-Westphalia, Germany, 50937
Active, Not Recruiting
15
Universitaetsklinikum Essen - Klinik fuer Knochenmarktransplantation (KMT)
Essen, North Rhine-Westphalia, Germany, 45147
Actively Recruiting
16
Universitaetsklinikum Muenster
Münster, North Rhine-Westphalia, Germany, 48149
Actively Recruiting
17
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, Saxony, Germany, 01307
Actively Recruiting
18
Universitaetsklinikum Leipzig, Selbststaendige Abteilung fur Haematologie und Internistische Onkologie
Leipzig, Saxony, Germany, 04103
Actively Recruiting
19
Universitaetsklinikum Jena Klinik fuer Innere Medizin II, Haematologie und Onkologie
Jena, Thuringia, Germany, 07740
Actively Recruiting
20
Universitaetsklinikum Jena - Klinik fuer Paediatrische Haematologie und Onkologie
Jena, Thuringia, Germany, 07747
Terminated
21
Charite Universitaetsmedizin
Berlin, Germany, 13353
Withdrawn
22
Helios Klinikum Berlin-Buch
Berlin, Germany, 287706
Actively Recruiting
23
University Hospital Bonn, Medizinische Klinik III
Bonn, Germany, 53127
Actively Recruiting
24
Universitaetsklinikum Essen - Klinik fuer Paediatrische Haematologie und Onkologie
Essen, Germany, 45147
Terminated
25
Klinikum der Johann Wolfgang Goethe University - University - Klinik fuer Paediatrische Haematologie und Onkologie
Frankfurt, Germany, 60590
Actively Recruiting
26
Universitaetsklinikum Freiburg - Zentrum fuer Kinder- und Jugendmedizin (ZKJ) - Klinik fuer Paediatrische Haematologie und Onkologie
Freiburg im Breisgau, Germany, 151595
Terminated
27
Universitaetsklinikum Freiburg
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
28
Universitatsklinikum
Kiel, Germany, 24105
Actively Recruiting
29
University Medical Center Mainz
Mainz, Germany, 55131
Actively Recruiting
30
Universitaetsklinikum Mannheim
Mannheim, Germany, 68167
Actively Recruiting
31
University Hospital Tuebingen Medical Center
Tübingen, Germany, 72076
Actively Recruiting
32
Department of Pediatric Hematology, Oncology and BMT, Wroclaw Medical University
Wroclaw, Lower Silesian Voivodeship, Poland, 50-556
Terminated
33
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie, Paastwowy Instytut Badawczy
Gliwice, Poland, 44-102
Actively Recruiting
34
Hospital Germans Trias i Pujol
Badalona, Spain, 08916
Actively Recruiting
35
Hospital Universitario Vall dHebron
Barcelona, Spain, 08035
Actively Recruiting
36
Institut Catal dOncologia
Barcelona, Spain, 08908
Actively Recruiting
37
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Actively Recruiting
38
Hospital Puerta De Hierro
Madrid, Spain, 28222
Actively Recruiting
39
Hospital Universitario Carlos Haya
Málaga, Spain, 29010
Actively Recruiting
40
Hospital Clinico Universitario de Valencia
Valencia, Spain, 46010
Actively Recruiting
41
Hospital Universitari i politecnic La Fe
Valencia, Spain, 46026
Actively Recruiting
42
Center for Allogeneic Stem Cell Transplantation and Cell Therapy (CAST), Karolinska Universitetssjukhuset Huddinge
Huddinge, Sweden, 126464
Terminated
Research Team
C
Clinical Trial Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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