Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06294691
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-05
First Post:
2024-02-28
Brief Title:
Effect of Stem Cell Infusion Time on aGVHD in Patients With Nonmalignant Hematologic Diseases
Sponsor:
Anhui Provincial Hospital
Organization:
Anhui Provincial Hospital
Study Overview
Official Title:
A Multicenter Randomized Controlled Study of the Effect of Stem Cell Infusion Time on the Development of aGVHD in Patients With Nonmalignant Hematologic Diseases After Allogeneic Peripheral Blood Hematopoietic Stem Cell Transplantation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
To observe the effect of stem cell infusion on the development of acute graft- versus-host disease aGVHD in patients with nonmalignant hematologic diseases after allogeneic peripheral blood hematopoietic stem cell transplantation allo-PBSCT
Detailed Description:
Acute graft-versus-host disease aGVHD is a major complication and non-recurrent cause of death after allogeneic hematopoietic stem cell transplantation allo-HSCT The human biological clock uses recurring environmental cues such as light and food intake to establish 24-hour rhythmic changes in sleep hormone secretion metabolism body temperature and immune function Current clinical aGVHD prevention strategies focus on suppression of donor lymphocyte function by drugs or immunomodulatory cells ignoring the impact of the recipients own functional changes on the graft The applicants previous retrospective cohort study found that the time of stem cell infusion severely affected the incidence of aGVHD and its severity after allogeneic peripheral blood hematopoietic stem cell transplantation allo- PBSCT Due to the lack of prospective clinical trial results on the effect of stem cell infusion time on the occurrence of aGVHD after allo-HSCT in the international arena as well as the possible influence of multiple confounding factors in the aforementioned single-center retrospective study the present study intends to randomize patients according to the time of stem cell infusion and to observe its effect on the incidence of aGVHD other transplant-related complications and long-term survival after allo-PBSCT of patients with nonmalignant hematologic diseases
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