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Updated: Mar 21, 2026
Bone Marrow Transplantation Platform to Investigate the Role of Dendritic Cells in Graft-versus-Host Disease
Published on: March 17, 2020
Clinical Development Programme of the Innovative Mesenchymal Stromal Cell Product MSC-FFM/MC0518 for
Robert Zeiser1, Halvard Bönig2,3, Elena Osswald4
1Department of Hematology, Oncology and Stem Cell Transplantation, Faculty of Medicine, Freiburg University Medical Center, Freiburg im Breisgau, Germany.
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.
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