Acute Graft-versus-host Disease Clinical Trial
Official title:
Mesenchymal Stem Cells Combined With CD25 Monoclonal Antibody and Calcineurin Inhibitors for Treatment of Steroid-resistant Acute Graft-versus-host Disease After Allogeneic Stem Cell Transplantation
The purpose of this study is to compare the efficacy of CD25 monoclonal antibody and calcineurin inhibitors with or without mesenchymal stem cells (MSCs) in treating patients with steroid-resistant acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic stem cell transplantation.
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an effective therapy for
several hematological disorders. Although good progress has been made in the prevention and
treatment of side effects associated with transplantation, aGVHDremains a common and
life-threatening complication with poor prognosis. Corticosteroids are still acted as the
first-line treatments of aGVHD, with a response rate of 50-80. However, those who failed to
initial therapy only have 10-30% long-term survival.
Mesenchymal stromal cells (MSCs) are a form of multipotent adult stem cells that can be
isolated from many tissues, such as bone marrow (BM), adipose tissue and umbilical cord.
Such cells possess the capacity to suppress immunological responses, support hematopoiesis
and repair tissues. Clinical applications of human MSCs are evolving rapidly for preventing
and treating GVHD. Although the results are still controversy, most prospective and
retrospective data suggest that MSCs are effective to aGVHD.
In the present study, the investigators will prospectively evaluate the efficacy and safety
of ex-vivo-expanded BM-derived MSCs from third-party donors combined with CD25 monoclonal
antibody and calcineurin inhibitors in treating patients with aGVHD.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04539470 -
Study to Evaluate the Safety and Pharmacokinetics of Efmarodocokin Alfa in Combination With Standard of Care in Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
|
Phase 1 | |
| Terminated |
NCT02245412 -
A Phase 2A Study of ALXN1007 in Participants With Newly Diagnosed Acute Lower Gastrointestinal Graft-Versus-Host Disease
|
Phase 2 | |
| Recruiting |
NCT02659657 -
Prophylaxis Roles of IL-2 Treatment on GVHD After Transplantation
|
Phase 2 | |
| Completed |
NCT03497273 -
Safety of Itacitinib in Combination With Corticosteroids for Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Japanese Subjects
|
Phase 1 | |
| Completed |
NCT05825833 -
Infliximab Efficacy in Relation to Therapeutic Drug Monitoring and Serum TNFα Levels in Pediatric HSCT
|
||
| Not yet recruiting |
NCT06294678 -
Effect of Stem Cell Infusion Time on aGVHD in Patients With Hematological Malignancies
|
Phase 3 | |
| Not yet recruiting |
NCT06294691 -
Effect of Stem Cell Infusion Time on aGVHD in Patients With Nonmalignant Hematologic Diseases
|
Phase 3 | |
| Recruiting |
NCT04285424 -
FMT for Steroid Resistant Gut Acute GVHD
|
Early Phase 1 | |
| Terminated |
NCT01903473 -
Donor Regulatory T Cells Infusion in Patients With Chronic Graft-versus-host Disease (GVHD)
|
Phase 2 | |
| Recruiting |
NCT02044185 -
Clinical Implications of HMGB1 in Patients Treated With Chemotherapy or Hematopoietic Stem Cell Transplantation
|
N/A | |
| Recruiting |
NCT01765634 -
Mesenchymal Stem Cells for Treatment of Refractory Acute Graft-versus-host Disease
|
Phase 2 | |
| Terminated |
NCT00282503 -
Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Acute Graft Versus-Host Disease
|
Phase 3 | |
| Recruiting |
NCT01521039 -
Assessment of MicroRNA Expression in Acute Graft-versus-Host Disease
|
||
| Terminated |
NCT03721965 -
Safety and Efficacy of Itacitinib in Combination With Corticosteroids for Treatment of Graft-Versus-Host Disease in Pediatric Subjects
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT04971551 -
A Study of Jaktinib for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease.
|
Phase 2 | |
| Completed |
NCT02743351 -
Study of ProTmune for Allogeneic HCT in Adult Patients With Hematologic Malignancies
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT06394895 -
Donor Neutrophil Subsets to Predict the Risk of aGVHD
|
||
| Terminated |
NCT05673876 -
A Study to Assess the Safety and Pharmacokinetics of GDC-8264 in Combination With Standard of Care in Participants With Acute Graft-Versus-Host Disease (aGVHD)
|
Phase 1 | |
| Recruiting |
NCT02611180 -
Dendritic Cells in Patients With Acute or Chronic Skin Graft Versus Host Disease
|