Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411184
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-05-07
Brief Title:
Safety and Efficacy of Treg Cell in the Treatment of GVHD
Sponsor:
Xuzhou Medical University
Organization:
Xuzhou Medical University
Study Overview
Official Title:
Safety and Efficacy of Treg Cell in the Treatment of GVHD After Allogeneic Hematopoietic Stem Cell Transplantation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized single-center phase 12a clinical trial without blinding Regulatory T cells Tregs have shown potential in treating various immune-related diseases including autoimmune disorders transplant rejection and inflammatory diseases The investigators plan to recruit participants for a clinical trial to evaluate the efficacy and safety of autologous Tregs in the treatment of GVHD
Detailed Description:
This randomized single-center phase 12a clinical trial conducted without blinding aims to explore the therapeutic promise of regulatory T cells Tregs Tregs are specialized immune cells that play a crucial role in modulating the bodys immune response thus offering a unique therapeutic avenue for immune-related conditions They have already demonstrated significant potential in managing a spectrum of diseases including autoimmune disorders such as multiple sclerosis and type 1 diabetes inflammatory conditions like inflammatory bowel disease and transplant rejection which is commonly encountered in organ and stem cell transplants The trials primary focus is on graft-versus-host disease GVHD a severe complication that can occur after allogeneic hematopoietic stem cell transplantation HSCT GVHD emerges when the donated immune cells attack the recipients tissues leading to symptoms ranging from mild to life-threatening Currently GVHD treatment relies on broad immunosuppressive therapies which often come with significant side effects and may not always be effective By recruiting participants for this clinical trial we aim to assess the safety and efficacy of Tregs in mitigating the immune systems attack on the recipients body Autologous Tregs offer a more targeted approach due to their ability to distinguish between harmful and beneficial immune responses potentially reducing the need for broad immunosuppression The trials structure includes dose-escalation and dose-expansion phases to evaluate optimal dosages assess any adverse reactions and measure the therapeutic benefits in GVHD management Through this systematic and thorough evaluation the investigators hope to refine Treg therapy and establish a clear safety profile Ultimately this trial seeks to unlock the therapeutic potential of autologous Tregs paving the way for future applications in a broader range of conditions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None