Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06242405
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-06
First Post:
2024-01-29
Brief Title:
Effect of Different Frequencies of Umbilical Cord-mesenchymal Stem Cells Through Peripheral Vein in Patients With ESLD
Sponsor:
General Hospital of Shenyang Military Region
Organization:
General Hospital of Shenyang Military Region
Study Overview
Official Title:
Efficacy and Safety of Different Frequencies of Human Umbilical Cord-mesenchymal Stem Cells Through Peripheral Vein in Patients With End-stage Liver Disease
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:
Stem cells are non-terminal cells that can self renew and replicate through symmetric or asymmetric division with the potential to differentiate into different types of cells and tissues Multiple studies have shown that mesenchymal stem cell has good safety and effectiveness in improving acute or chronic liver injury Randomized controlled trials have confirmed the efficacy of single infusion of stem cells in treating ESLD It seems that the multiple infusion is better than single infusion
Detailed Description:
Ninety-two participants with end-stage liver disease admitted to the Department of Gastroenterology of the General Hospital of Northern Theater Command are expected to be enrolled over a period of 1 year The participants will be randomly divided into single-infusion and double-infusion stem cell groups by peripheral vein The investigators will observe alanine aminotransferase aspartate aminotransferase alkaline phosphatase total bilirubin albumin prothrombin time international normalized ratio model for end-stage liver disease score and Child-Pugh score in patients at weeks 24 post-infusion
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