GvHD Hub

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.

The GvHD Hub held a virtual symposium on October 21, 2025, titled, Guidance vs practice: How can we improve treatment of SR-GvHD? Here, we share a presentation by Daniel Wolff, University Hospital Regensburg, DE, discussing the early treatment strategies for SR-GvHD. Wolff provided an overview of the treatment options for second-line treatment after steroids and subsequent advanced-line options, emphasizing that early detection of disease progression and sufficient treatment intervention are crucial, as advanced disease is often nonreversible. Wolff discussed response assessments to first-line steroid treatment and second-line treatments, and outlined the treatment options for patients with SR-cGvHD, including ruxolitinib, belumosudil, axatilimab, ibrutinib, and extracorporeal photopheresis. This educational resource is independently supported by Sanofi.​ All content was developed by SES in collaboration with an expert steering committee. Funders were allowed no influence on the content of this resource.

The GvHD Hub held a virtual symposium on October 21, 2025, titled, Guidance vs practice: How can we improve treatment of SR-GvHD. Here, we share a presentation by Steven Pavletic, Bethesda, US, discussing quality of life and symptoms in cGvHD. Pavletic discussed the importance of the assessment of quality of life using patient-reported outcome measures (PROMs) in both clinical trials and clinical practice in cGvHD, outlining the frequently used PROMs in GvHD, including cGvHD-specific and dimension-specific measures. Pavletic highlighted that incorporation of PROMs into standard of care practice may ultimately lead to more tailored and effective clinical assessments. This educational resource is independently supported by Sanofi. All content was developed by SES in collaboration with an expert steering committee. Funders were allowed no influence on the content of this resource.

The GvHD Hub held a virtual symposium on October 21, 2025, titled, Guidance vs practice: How can we improve treatment of SR-GvHD? Here, we share a presentation by Mohamad Mohty, Sorbonne University Hôpital Saint-Antoine, Paris, FR, discussing the importance of real-world data (RWD) in allogeneic stem cell transplantation with a focus on cGvHD.Mohty provided an overview of RWD, including their use in regulatory decision-making, types of RWD, study designs, and limitations. Mohty explored whether results of pivotal clinical trial results can be reproduced with RWD, highlighting the consistent outcomes observed in a French compassionate use program of belumosudil.This educational resource is independently supported by Sanofi.All content was developed by SES in collaboration with an expert steering committee. Funders were allowed no influence on the content of this resource.

The GvHD Hub was pleased to speak with Robert Zeiser. We asked, What are the current treatment options for steroid-refractory chronic GvHD (SR-cGvHD)? In this interview, Zeiser explores the current treatment options for SR-cGvHD, such as ruxolitinib, ibrutinib, belumosudil, and axatilimab, and discusses the different mechanisms of action involved in targeting distinct pathways involved in cGvHD pathogenesis. Zeiser notes that future directions may focus on identifying optimal combination therapies for patients with SR-cGvHD. This educational resource is independently supported by Sanofi. All content was developed by SES in collaboration with an expert steering committee. Funders were allowed no influence on the content of this resource.

Despite advances in preventing chronic graft-versus-host disease (GvHD), transplant recipients continue to be affected, with steroid-refractoriness associated with significantly increased morbidity and mortality.1The GvHD Hub spoke with Corey Cutler, Dana-Farber Cancer Institute, Boston, US. We asked, What are the major challenges in the treatment of steroid-refractory GvHD (SR-GvHD), and how can clinicians overcome these?This educational resource is independently supported by Sanofi. All content was developed by SES in collaboration with an expert steering committee. Funders were allowed no influence on the content of this resource.

During the GvHD Hub Steering Committee Meeting on May 12, 2025, key opinion leaders met to discuss how to improve measurement of quality of life (QoL) and use of patient-reported outcomes (PROs) in cGvHD. The discussion was preceded by a presentation by Mohamad Mohty, and the discussion featured Nico Gagelmann, Bipin Savani, Ali Bazarbachi, Corey Cutler, and Andrew Harris. Mohty began by explaining the necessity of measuring QoL in patients with graft-versus-host disease (GvHD) and the current use of PROs in trials and clinical practice. During the discussion, the steering committee members provided insight into the difficulties implementing QoL assessment in clinical practice, and potential solutions.This independent educational activity is supported by Sanofi. All content was developed independently. The funder was allowed no influence on the content of this activity. 

During the GvHD Hub Steering Committee Meeting on May 12, 2025, key opinion leaders met to discuss the use of extracorporeal photopheresis + ruxolitinib to prevent cGvHD in patients with SRaGvHD. The discussion was preceded by a presentation by Nico Gagelmann, chaired by Mohamad Mohty, and featured Robert Zeiser, Bipin Savani, Daniel Wolff, Corey Cutler, and Andrew Harris.  Gagelmann began by presenting the design and rationale of a real-world retrospective study in Germany, response and survival outcomes, and key takeaways. During the discussion, the steering committee members provided their thoughts on the use of combination therapies, specifically ECP + ruxolitinib, in SR-GvHD, and potential directions for future studies.  This independent educational activity was supported by Therakos. All content was developed independently. The funder was allowed no influence on the content of this activity.