Clinical Trials Logo
  1. Home
  2. Graft Versus Host Disease
  3. NCT00284986

Safety and Efficacy of Prochymal® for the Salvage of Treatment-Refractory Acute GVHD Patients

Graft Versus Host Disease Clinical Trial

Official title:
A Phase II Open Label Study to Evaluate the Safety and Efficacy of Prochymal® (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) Infusion for the Salvage of Treatment-Refractory Acute GVHD Patients

Clinical Trial Summary

This study is designed to evaluate the safety and efficacy of Prochymal® (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) in participants experiencing treatment-refractory acute GVHD, Grades III-IV, that is refractory to standard first-line therapies and at least one second-line therapy.

Clinical Trial Description

Allogeneic hematopoetic stem cell transplantation (HCT) is used in the treatment of a variety of hematological, myeloproliferative and lymphoproliferative disorders, and malignancies involving solid tumors. Patients receiving HCT can develop a life-threatening condition called graft versus host disease (GVHD). GVHD occurs when donor T cells from the donor bone marrow recognize host cells as "foreign" and initiate an inflammatory immunological response. The standard of care for treatment of acute GVHD consists of intravenous delivery of methylprednisolone starting on day 1 and continuation of either cyclosporine or tacrolimus. This regimen of steroids and immunosuppressive drugs may relieve symptoms of GVHD, but some patients are refractory to current standard of care treatment. For treatment-refractory patients with grades III-IV GVHD mortality is approximately 80%. A therapy that could effectively suppress the immunological response from GVHD and help repair the damaged tissue could significantly decrease the mortality rate from this disease. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00284986
Study type Interventional
Source Mesoblast, Ltd.
Contact
Status Completed
Phase Phase 2
Start date November 18, 2005
Completion date February 8, 2007
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