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MSCs as an alternative to ruxolitinib: Real-world use of MSC-FFM in aGvHD
Do you know... Which statement best describes the findings from the 2025 retrospective analysis by Bonig, et al. of real-world outcomes of MSC-FFM in patients with aGvHD who were either ruxolitinib-naïve or ruxolitinib-exposed?
Glucocorticoids are the standard first-line treatment of acute graft-versus-host disease (aGvHD) but fail to yield a response in ~60% of patients.1 Ruxolitinib, a Janus kinase (JAK) inhibitor, is currently recommended as a second-line treatment for steroid-refractory aGvHD (SR-aGvHD).1 Patients with steroid- and ruxolitinib-refractory aGvHD have a poor prognosis,2 highlighting the need for alternative or additional treatment options.
Mesenchymal stromal cells (MSCs) are an emerging treatment option for patients with treatment-refractory aGvHD. MSC-Frankfurt am Main (MSC-FFM), is an MSC preparation produced from bone marrow-derived mononuclear cells of eight donors, with real-world evidence supporting the effectiveness and tolerability of this approach in patients with aGvHD.3-6 This visual abstract summarizes four real-world studies on MSC-FFM in aGvHD, including both steroid- and ruxolitinib-refractory disease, as well as in patients without prior exposure to ruxolitinib.
The ongoing phase II BALDER (NCT06075706) and phase III IDUNN (NCT04629833) trials are investigating MSC-FFM compared with best available therapy, including ruxolitinib, for the first-line treatment of SR-aGvHD in pediatric and adult patients.7,8
This educational resource is independently supported by Medac. All content was developed by SES in collaboration with an expert steering committee. Funders were allowed no influence on the content of this resource.
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Which consideration most strongly guides your decision to escalate therapy in SR-aGvHD?
