Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06167473
Status:
RECRUITING
Last Update Posted:
2023-12-12
First Post:
2023-11-23
Brief Title:
Effect of Different Dosage 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 Dosage of Umbilical Cord-mesenchymal Stem Cells Through Peripheral Vein in Patients With End-stage Liver Diseases
Status:
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:
None
Brief Summary:
There is a rise in the prevalence of end-stage liver disease during the last decade End-stage liver disease has become one of the leading causes of death in Western countries Liver transplantation is the only curative treatment for patients with end-stage liver disease However the shortage of donor high cost and postoperative complications limit its wide application in clinical practice At present stem cell-based therapy has been developed as an alternative treatment for end-stage liver disease Stem cells can be differentiated into a variety of cell types and stem cell transplantation mainly umbilical cord-mesenchymal stem cells has attracted more and more attention in the treatment of end-stage liver disease The investigators therefore conduct a randomised controlled trial to investigate the efficacy and safety of human umbilical cord tissue mesenchymal stem cells for the treatment of end-stage liver disease
Detailed Description:
Twenty-two subjects with end-stage liver disease attending the Department of Gastroenterology of the General Hospital of the Northern Theatre of Operations are expected to be enrolled over a period of 1 year The participants will be randomly divided into a low-dose stem cell group 1106cellskg per infusion and a medium-high-dose stem cell group 3106cellskg per infusion which are infused by peripheral vein The investigators will observe ALT AST ALP TBIL ALB PT INR MELD score and Child-Pugh score in patients at weeks 1 4 8 12 24 and 48 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?:
False
Is an FDA AA801 Violation?:
None