Clinical Trials Logo
  1. Home
  2. Graft Versus Host Disease
  3. NCT05333029

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 April 1, 2024
Completion date June 1, 2025
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03357159 - Anti T-lymphocyte Immunoglobulin With Post Transplant Cyclophosphamide to Prevent GVHD Post Allogeneic Transplantation Phase 2
Completed NCT00003270 - Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer Phase 2
Terminated NCT02877082 - Tacrolimus, Bortezomib, & Thymoglobulin in Preventing Low Toxicity GVHD in Donor Blood Stem Cell Transplant Patients Phase 2
Recruiting NCT01385124 - Cannabidiol for Graft Versus Host Disease (GVHD) Prophylaxis in Allogeneic Stem Cell Transplantation Phase 1/Phase 2
Withdrawn NCT01616680 - Brentuximab Vedotin in Treating Patients With Steroid-Resistant Acute Graft-Versus-Host Disease Phase 2
Recruiting NCT01810926 - T&B Depletion Non Malignant Phase 2
Completed NCT01379209 - Intravenous Administration of RGI-2001 in Patient Undergoing Allogenic Hematopoietic Stem Cell Transplantation (AHSCT) Phase 1/Phase 2
Completed NCT01233921 - Palifermin in Preventing Chronic Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant for Hematologic Cancer N/A
Recruiting NCT00986557 - T-Lymphocyte Infusion or Standard Therapy in Treating Patients at Risk of Cytomegalovirus Infection After a Donor Stem Cell Transplant Phase 2
Enrolling by invitation NCT00972660 - Safety and Efficacy Study of Allogenic Mesenchymal Stem Cells to Treat Extensive Chronic Graft Versus Host Disease Phase 2
Terminated NCT00555048 - Alemtuzumab, Busulfan, and Cyclophosphamide Followed By a Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer Phase 1/Phase 2
Terminated NCT00373815 - Everolimus in Combination With Cyclosporine A and Prednisolone for the Treatment of Graft Versus Host Disease Phase 1
Terminated NCT00608517 - Treatment of Single or Double Umbilical Cord Trans + Graft-versus-host Disease (GVHD) Prophylaxis w/ Tacrolimus & Mycophenolate Mofetil N/A
Completed NCT00056875 - Recombinant Human Keratinocyte Growth Factor in Unrelated and Related Transplants Phase 1/Phase 2
Recruiting NCT05808985 - Intestinal Microbiome-based Research for the Prevention of Acute GVHD Phase 2
Completed NCT00813618 - Study of MEDI 507 in the Treatment of Pediatric Patients Phase 1
Completed NCT00003398 - Bone Marrow Transplantation in Treating Patients With Hematologic Cancer Phase 4
Terminated NCT00005641 - Removal of T Cells to Prevent Graft-Versus-Host Disease in Patients Undergoing Bone Marrow Transplantation Phase 2
Completed NCT02663622 - Phase II Trial of Efprezimod Alfa (CD24Fc, MK-7110) for the Prevention of Acute Graft-Versus-Host Disease (GVHD) Following Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) (MK-7110-002) Phase 2
Completed NCT00577278 - A Phase II Study of Allo-HCT for B-Cell NHL Using Zevalin, Fludarabine and Melphalan Phase 2