Two randomized controlled trials evaluate MSC-FFM in steroid-refractory acute graft-versus-host disease, suggesting potential new treatments.
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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Zeiser et al. (2026) studied this question.
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