NCT03668171

Mesenchymal Stem Cell Transplantation for Acute-on-chronic Liver Failure

Mesenchymal Stem Cell Transplantation for Acute-on-chronic Liver Failure, a Randomized, Double Blind, Placebo Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Xijing Hospital of Digestive Diseases · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Mesenchymal stem cells (MSC) has been reported to improved outcomes of acute-on-chronic liver failure(ACLF). More randomization controlled studies are needed to confirm the effect of MSC treatment for ACLF. This study aimed to investigate the efficacy of mesenchymal stem cells in ACLF patients. This study is an double-blind multicenter randomized and placebo-controlled study. Patients with with ACLF will be randomly assigned to receive MSC treatment (experimental) or standard medical treatment (control). Three times of MSC infusion (0.1-1x10E6cells/kg body weight) via peripheral vein will be given to the experimental group (once per week). The primary outcome is 12 week mortality. Secondary outcomes are clinical remission rate and changes of liver function indices and liver function scores.

Conditions

• Acute-On-Chronic Liver Failure

Interventions

Type	Name	Description
PROCEDURE	mesenchymal stem cell transplantation or placebo infusion via peripheral vein	0.1-1x10E6 MSCs/kg body weight will be administered via peripheral vein for 3 times at week 0, 4 and 8 mesenchymal stem cell mesenchymal stem cell infusion produced by Cell products of National Engineering Research Center(short for CPNERC), Tianjin, China For control group, placebo infusions will be given to the participants at the same time points

Timeline

• Start date: 2017-12-10
• Primary completion: 2019-12-31
• Completion: 2020-12-31
• First posted: 2018-09-12
• Last updated: 2018-09-12

Locations

1 site across 1 country: China