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. 

Mesenchymal stromal cells (MSCs) have emerged as a potential therapy option in patients with steroid-refractory graft-versus-host disease (SR-GvHD).1 MSCs do not express human leukocyte antigen class II and can therefore be administered without the need for matching, giving them a distinct advantage over other cellular therapies.1

The GvHD Hub spoke to Robert Zeiser, Medical Center – University of Freiberg, Freiberg, DE, about his key insights into MSCs for aGvHD, and the current clinical trial landscape.

The MSC clinical trial landscape

• The first patient treated with MSCs, in 2004, experienced improvements in gastrointestinal and hepatic manifestations of severe GvHD after infusion of haploidentical MSCs. Since then, there have been multiple studies investigating MSCs as a potential treatment in aGvHD, although not all trials have met their primary endpoint.
• In general, MSCs are well tolerated by patients, with promising efficacy demonstrated in clinical trials; however, there is some variation in response rates.
• The mechanism of action of MSCs is still unclear; current evidence suggests that intravascular MSC destruction is followed by monocyte-mediated immune modulation, with monocytes playing a key role in the efficacy of the treatment.

Recent developments

• Remestemcel-L-rknd, an allogeneic bone marrow-derived MSC therapy, was approved by the U.S. Food and Drug Administration (FDA) on December 18, 2024, for the treatment of steroid-refractory acute graft-versus-host disease (aGvHD) in pediatric patients (aged ≥2 months).
• Another allogeneic MSC product, Mesenchymal Stromal Cells-Frankfurt am Main (MSC-FFM), is currently being investigated in the phase III IDUNN trial (NCT04629833) across multiple centers in Europe. The trial will compare MSC-FFM to the best available therapy in patients with SR-aGvHD. This therapy differs from other MSC products, as it is made from pooling cells from multiple donors rather than a single donor, and is already available for use in Germany under Hospital Exemption.

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The GvHD Hub was pleased to speak to Andrew Gennery, Newcastle University and Great North Children’s Hospital, Newcastle upon Tyne, UK, and Chair of the UK Photopheresis Society, about the future directions of extracorporeal photopheresis (ECP) for the treatment of graft-versus-host disease (GvHD).

View on the GvHD Hub here: https://gvhdhub.com/medical-information/future-perspectives-of-ecp-for-gvhd-treatment

Gennery begins by providing a background to using ECP in pediatric patients, including the potential complications involved and how to mitigate these. He then discusses the process of ECP, including treatment scheduling, and its efficacy in different types of GvHD.

Gennery goes on to speak about how the treatment landscape for GvHD has changed in the last 5 years, how it might change in the future, and where ECP fits in as an immunomodulatory agent. In the future, ECP may be combined with the newer immunosuppressive agents that are approved, or in development, for the treatment of GvHD to deliver positive outcomes for patients.

This independent educational activity was supported by Mallinckrodt Pharmaceuticals. All content was developed independently by the faculty. The funder was allowed no influence on the content of this activity.

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On April 14, 2024, the GvHD Hub held a symposium at the 50th European Society for Bone and Marrow Transplantation (EBMT) Annual Meeting on the role of extracorporeal photopheresis (ECP) in the management of chronic graft-versus-host disease (cGvHD).

Zinaida Perić, University of Rijeka, Rijeka, HR, shared her thoughts on patient eligibility, treatment optimization, and follow-up after treatment with ECP for cGvHD. She also discussed a case report of a patient with steroid-refractory (SR)-cGvHD, plus retrospective and prospective data on the use of ECP in cGvHD. In addition, she shared the Nordic ECP Quality Group treatment guidelines for SR-cGvHD.

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