Graft Vs Host Disease Clinical Trial
Official title:
Alterations in Intestinal Microbiota, Metabolites, and Immune Cells Pre- and Post-Transplantation of Allogeneic Hematopoietic Stem Cells
This research project delves into the critical role of gut immunity in the occurrence and progression of acute graft-versus-host disease (aGVHD) post allogeneic hematopoietic stem cell transplantation (allo-HSCT). Addressing the current gaps in understanding the involvement of intestinal microbiota, metabolites, and cellular metabolism in clinical aGVHD, the study involves comprehensive analyses on 200 allo-HSCT patients and 50 healthy volunteers. By scrutinizing changes in gut microbiota, metabolites, and immune cell metabolism, the research aims to shed light on their roles in allo-HSCT and their correlation with post-transplant complications. The findings are poised to offer crucial insights for diagnosing and prognosticating complications following transplantation.
The intestinal immune system plays a pivotal role in the onset, progression, and evolution of acute graft-versus-host disease (aGVHD) following allogeneic hematopoietic stem cell transplantation (allo-HSCT). However, the precise contributions and mechanisms underlying the involvement of intestinal microbiota, metabolites, and cellular metabolism in immune regulation during clinical aGVHD remain unclear. This research initiative aims to collect peripheral blood, fecal, and urine samples from 200 patients before and after transplantation as well as 50 healthy volunteers. Comprehensive analyses, including metagenomics, 16S rRNA sequencing, transcriptomics, metabolomics, single-cell sequencing, as well as assessments of immune cell function and inflammatory cytokines, will be conducted. Additionally, longitudinal follow-up observations will be performed to monitor post-transplant complications, relapse and immune reconstitution. By investigating the dynamics of gut microbiota, metabolites, and cellular metabolism and analyzing their correlation with changes in immune responses, this study seeks to elucidate the roles of intestinal microbiota, metabolites, and immune cell metabolism in the context of allo-HSCT. The findings are anticipated to provide insights into the correlation between these factors and outcomes of allo-HSCT patients, contributing valuable evidence for the diagnosis and prognosis assessment of complications following transplantation. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06080490 -
Tacrolimus Blood Concentration and Transplant-related Outcomes in Pediatric HSCT Recipients
|
||
Completed |
NCT00001637 -
Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults
|
Phase 2 | |
Withdrawn |
NCT04728646 -
Evaluation of Dextenza in Patients With Ocular GVHD and Effects on Ocular Surface Disease Outcomes
|
Phase 4 | |
Suspended |
NCT01972438 -
A Randomized, Controlled, Double-masked, Clinical Trial of Autologous Serum Eye Drops for Severe Ocular Chronic Graft-versus-host Disease (GVHD) in Hematopoietic Stem Cell Transplant (HSCT) Patients
|
Phase 1/Phase 2 | |
Completed |
NCT01221766 -
Impact of Adnexal Involvement of the Severity and Prognosis of Chronic Graft-versus-Host Disease
|
N/A | |
Recruiting |
NCT01764100 -
Mesenchymal Stromal Cells (MSCs) for the Treatment of Graft Versus Host Disease (GVHD)
|
Phase 1 | |
Completed |
NCT00760981 -
A Pilot Study of Imatinib Mesylate in Steroid Refractory Chronic Graft Versus Host Disease
|
Phase 1 | |
Terminated |
NCT00298324 -
Myfortic - Treatment for Extensive cGvHD
|
Phase 3 | |
Completed |
NCT00224874 -
Treatment for Acute Graft-Versus-Host Disease (BMT CTN 0302)
|
Phase 2 | |
Completed |
NCT00023491 -
Potential of Transplanted Stem Cells to Mature Into Salivary Gland and Cheek Cells
|
N/A | |
Completed |
NCT00023530 -
Blood and Marrow Transplant Clinical Research Network
|
N/A | |
Recruiting |
NCT05111834 -
IRENE-G Study: Impact of Resistance Exercise and Nutritional Endorsement on GvHD Symptoms
|
N/A | |
Completed |
NCT02841995 -
A Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Chronic Graft Versus Host Disease
|
Phase 2 | |
Recruiting |
NCT04622956 -
GVHD Prophylaxis With Methotrexate in Haploidentical HCT Using Posttransplant Cyclophosphamide
|
Phase 1/Phase 2 | |
Recruiting |
NCT03340155 -
Mechanisms of Action of Photo(Chemo)Therapy in Skin Diseases
|
N/A | |
Recruiting |
NCT03836690 -
Transfer of Effector Memory T Cells (Tem) Following Allogeneic Stem Cell Transplantation
|
Phase 1 | |
Not yet recruiting |
NCT06450925 -
Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.
|
N/A | |
Not yet recruiting |
NCT02506231 -
The Effect of Folinic Acid Rescue Following MTX GVHD Prophylaxis on Regimen Related Toxicity and Transplantation Outcome
|
Phase 2/Phase 3 | |
Recruiting |
NCT01042509 -
Combination of Alemtuzumab and Rituximab at Low-doses in Refractory Chronic Graft-Versus-Host Disease
|
N/A | |
Terminated |
NCT00117702 -
Prevention of the Graft-Versus-Host-Disease in Patients After Stem Cell Transplantation With Tacrolimus and Everolimus
|
Phase 2/Phase 3 |