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MSCs: From clinical trials to clinical practice
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During the GvHD Hub Steering Committee Meeting in December 2025, key opinion leaders met to discuss the mechanism of action and clinical data supporting the use of mesenchymal stromal cells (MSCs) for the treatment of graft-versus-host disease (GvHD). The meeting opened with a presentation by Robert Zeiser and featured a discussion including Mohamad Mohty, Yi-Bin Chen, Daniel Wolff, Florent Malard, Corey Cutler, and Andrew Harris.
During his presentation, Zeiser outlined the proposed mechanism of action of MSCs, describing how they promote an immunosuppressive and immunoregulatory environment. He explored the evolving clinical trial landscape of MSCs in the treatment of GvHD, beginning with the first reported use in 2004, and summarized key trial results leading to the approval of the MSC products remestemcel-L and JR-031. Zeiser highlighted the challenge of MSC product variability, which has contributed to heterogenous response rates across studies. He introduced MSC-Frankfurt am Main (FFM), an MSC product generated by pooling bone marrow-derived mononuclear cells from eight human leukocyte antigen (HLA)-disparate donors to reduce variability. He also explored MSC-FFM outcomes across real-world cohorts and presented the study designs of two ongoing phase II/III trials.
This discussion topic is supported by Medac, who provided funding. All content was developed independently by the steering committee in collaboration with SES. Funders were allowed no influence on the content of the discussion.
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