Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06164288
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-11
First Post:
2023-11-21
Brief Title:
Safety and Efficacy Study of hAESCs Therapy for aGVHD
Sponsor:
Shanghai iCELL Biotechnology Co Ltd Shanghai China
Organization:
Shanghai iCELL Biotechnology Co Ltd Shanghai China
Study Overview
Official Title:
A Phase I Study to Evaluate the Safety and Efficacy of Human Amniotic Epithelial Stem CellhAESCsInjection Treatment for the Patients With Refractory aGVHD After Allogeneic Hematopoietic Cell Transplantation HCT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
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:
aGVHDhAESCs
Brief Summary:
Allogeneic hematopoietic stem cell transplantation allo-HSCT a process in which hematopoietic stem cells from a donor are injected into the recipients body are the treatment of choice for many hematologic malignancies Graft-versus-host disease GVHD is a common and important complication after allogeneic HSCT GVHD is a major obstacle to the success of HSCT treatment and a leading cause of death after HSCT treatment
Hormone therapy is currently the standard treatment for aGVHD ie the first-line treatment However 4050 of aGVHD cannot be controlled by hormone therapy and additional therapeutic intervention is required According to the National Comprehensive Cancer Network NCCN clinical practice guidelines for hematopoietic stem cell transplantation - pre-transplant recipient evaluation and management of GVHD 2021V3 the recommended drugs for second-line treatment of grade IIIV aGVHD include alemtuzumab α-1 antitrypsin antithymocyte globulin basiliximab calcineurin inhibitors etanercept extracorporeal photopheresis replacement therapy infliximab mammalian rapamycin target protein inhibitors mycophenolate mofetil Pentostatin ruxolitinib tocilizumab Second-line treatment is based on retrospective data and there is no standard salvage therapy which is reflected in the inconsistent treatment strategy for aGVHD across transplant centers
One of the biological functions of hAESCs in amniotic membranes in vivo is to exert reproductive immunomodulatory effects and protect the fetus from rejection by the maternal immune system so hAESCs have natural immunomodulatory functions hAESCs have significant inhibitory effects on T cells antigen-presenting cells APCs natural killer NK cells macrophages neutrophils B cells and other immune cells associated with organ damage during the pathogenesis of aGVHD and hAESCs have great potential in the treatment of aGVHD Therefore the sponsor developed hAESCs injections intended for the treatment of aGVHD
The experimental drug in this study is hAESCs injection which is intended to be used for the treatment of adult patients with grade IIIIV refractory aGVHD after hematopoietic stem cell transplantation and to explore the safety and preliminary efficacy of its treatment
Hormone therapy is currently the standard treatment for aGVHD ie the first-line treatment However 4050 of aGVHD cannot be controlled by hormone therapy and additional therapeutic intervention is required According to the National Comprehensive Cancer Network NCCN clinical practice guidelines for hematopoietic stem cell transplantation - pre-transplant recipient evaluation and management of GVHD 2021V3 the recommended drugs for second-line treatment of grade IIIV aGVHD include alemtuzumab α-1 antitrypsin antithymocyte globulin basiliximab calcineurin inhibitors etanercept extracorporeal photopheresis replacement therapy infliximab mammalian rapamycin target protein inhibitors mycophenolate mofetil Pentostatin ruxolitinib tocilizumab Second-line treatment is based on retrospective data and there is no standard salvage therapy which is reflected in the inconsistent treatment strategy for aGVHD across transplant centers
One of the biological functions of hAESCs in amniotic membranes in vivo is to exert reproductive immunomodulatory effects and protect the fetus from rejection by the maternal immune system so hAESCs have natural immunomodulatory functions hAESCs have significant inhibitory effects on T cells antigen-presenting cells APCs natural killer NK cells macrophages neutrophils B cells and other immune cells associated with organ damage during the pathogenesis of aGVHD and hAESCs have great potential in the treatment of aGVHD Therefore the sponsor developed hAESCs injections intended for the treatment of aGVHD
The experimental drug in this study is hAESCs injection which is intended to be used for the treatment of adult patients with grade IIIIV refractory aGVHD after hematopoietic stem cell transplantation and to explore the safety and preliminary efficacy of its treatment
Detailed Description:
None
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