Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444022
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2022-07-08
Brief Title:
hAESCs Prevent Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation
Sponsor:
Nanfang Hospital Southern Medical University
Organization:
Nanfang Hospital Southern Medical University
Study Overview
Official Title:
Clinical Study of hAESCs on Prevention of Acute Graft-versus-host Disease After 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 parallel controlled clinical study evaluating the safety and efficacy of hAECs in preventing aGVHD after HSCT
Detailed Description:
This study is a controlled trial with 18 subjects enrolled in the experimental group or the control group The study will consist of four phases including screening phase preparation phase hAESCs treatment phase and observational follow-up period The cell dose of the experimental group was 1x106 cellskg and the control group is infused placebo the composition was the same as hAESCs injection excipients but did not contain hAESCs The infusion of hAESCsplacebo at the day before HSCT and 7th days after HSCT
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