Evidence map›Paper›PMID 41858687›Full record

ArticleTransfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie2026

Clinical Development Programme of the Innovative Mesenchymal Stromal Cell Product MSC-FFM/MC0518 for Steroid-Refractory Acute Graft-Versus-Host Disease: Design of 2 Randomised Controlled Trials in Adult and Paediatric Patients.

Robert Zeiser, Halvard Bönig, Elena Osswald, Uwe Pichlmeier, Ann-Kristin Möller, Michael Tribanek, Maria Lazarou-Wild, Renate von der Weth, Lisa-Marie Pfeffermann, Peter Bader

2 registry-linked trialsAbstract read
In one paragraph

Article in Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04629833 phase3recruitingnot on this map

A Randomised, Open-label, Multicentre, Phase 3 Trial of First-line Treatment With Mesenchymal Stromal Cells MC0518 Versus Best Available Therapy in Adult and Adolescent Subjects With Steroid-refractory Acute Graft-versus-host Disease After Allogeneic Haematopoietic Stem Cell Transplantation (IDUNN Trial)

TypeinterventionalSponsormedac GmbHRan2021 to 2030Enrolled210ConditionsSteroid-refractory Acute Graft-versus-host DiseaseArmsMC0518, BAT
NCT06075706 phase2active not recruitingnot on this map

A Randomised, Open-label, Controlled, Multicentre, Phase 2 Trial of First-line Treatment With Mesenchymal Stromal Cells MC0518 Versus Best Available Therapy in Paediatric Participants With Steroid-refractory Acute Graft-versus-host Disease After Allogeneic Stem Cell Transplantation (BALDER Trial)

TypeinterventionalSponsormedac GmbHRan2023 to 2031Enrolled49ConditionsSteroid-refractory Acute Graft-versus-host DiseaseArmsMC0518, BAT
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Mesenchymal Stromal Cells: From Bench to Bedside and Back.Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2026
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Robert ZeiserDepartment of Hematology, Oncology and Stem Cell Transplantation, Faculty of Medicine, Freiburg University Medical Center, Freiburg im Breisgau, Germany.
Halvard BönigFaculty of Medicine, Institute for Transfusion Medicine and Immunohematology, Goethe University, Frankfurt am Main, Germany.
Elena Osswaldmedac GmbH, Wedel, Germany.
Uwe Pichlmeiermedac GmbH, Wedel, Germany.
Ann-Kristin Möllermedac GmbH, Wedel, Germany.
Michael Tribanekmedac GmbH, Wedel, Germany.
Maria Lazarou-Wildmedac GmbH, Wedel, Germany.
Renate von der Wethmedac GmbH, Wedel, Germany.
Lisa-Marie PfeffermannGerman Red Cross Blood Service BaWüHe, Institute Frankfurt, Frankfurt am Main, Germany.
Peter BaderDepartment of Pediatrics, Division of Stem Cell Transplantation and Immunology, Goethe University Frankfurt, Frankfurt am Main, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: Acute graft-versus-host disease (aGvHD) is a potentially life-threatening complication that can occur following allogeneic haematopoietic stem cell transplantation. Although corticosteroids remain the standard first-line therapy, a considerable number of patients fail to respond adequately, leading to significant morbidity. Methods: Mesenchymal stromal cells (MSCs) are being investigated as a therapeutic option in this setting due to their immunomodulating and tissue-regenerative properties. Two ongoing clinical trials - IDUNN (NCT04629833) and BALDER (NCT06075706) - are assessing the role of the innovative product MSC-FFM/MC0518 in managing steroid-refractory aGvHD (SR-aGvHD). In parallel, a dedicated surveillance programme is collecting long-term efficacy and safety data to inform clinical use beyond the controlled trial environment. Conclusion: The IDUNN and BALDER trials will deliver definitive evidence on the efficacy and safety of MC0518 in SR-aGvHD and may shape future therapeutic strategies.

Indexed as

Acute graft-versus-host diseaseAllogeneic haematopoietic stem cell transplantationMC0518Mesenchymal stromal cellsMSC-FFMSteroid-refractory acute graft-versus-host disease

Identifiers

PMID41858687
PMCPMC12999213

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.