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Extracorporeal Photopheresis and Mesenchymal Stem Cell Infusion for GVHD

Graft Versus Host Disease Clinical Trial

Official title:
A Phase II Study of Combination Treatment With Extracorporeal Photopheresis and Mesenchymal Stem Cell Infusion for High-Risk and Steroid-Refractory Acute GVHD

Clinical Trial Summary

The purpose of this study is to see if two treatments (extracorporeal photopheresis and Mesenchymal Stromal Cell (MSC) infusion, can be given safely together, and if they improve the symptoms of a Graft versus Host Disease (GvHD), a complication that can occur in people who undergo stem cell transplant.

Clinical Trial Description

This is a Phase II study of human MSCs for the treatment of High-Risk aGVHD (HRaGVHD) and steroid-refractory acute GVHD (SRaGVHD). MSCs are cells that can help the body heal from injury and maintain a healthy immune system. MSCs have been used to prevent and treat a GvHD. In previous human studies, MSC infusion has been generally well-tolerated and safe, and in some cases, benefit was reported. The donor of the MSCs could be a relative or a stranger, and does not need to be the same individual who donated the stem cells for the stem cell transplant. All donors are screened for infectious diseases, similar to a blood donor. All donors have a physical exam. Corticosteroids may be administered with MSCs/ECP. Continued use of anti-infective medications, GVHD prophylaxis medications (including calcineurin inhibitors), transfusion support, and topical steroid therapy is permitted. Participants will be assessed for safety and tolerability using a continuous monitoring approach. In order to be included in the tolerability review, participants must have received at least 1 treatment with MSCs. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05333029
Study type Interventional
Source Case Comprehensive Cancer Center
Contact Molly Gallogly, MD, PhD
Phone 1-800-641-2422
Email CTUReferral@UHhospitals.org
Status Not yet recruiting
Phase Phase 2
Start date October 1, 2024
Completion date June 1, 2025
View Details
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