NCT03209986

Trial of Mesenchymal Stem Cell Transplantation in Decompensated Liver Cirrhosis

Randomized Control Trial of Mesenchymal Stem Cell Transplantation in Decompensated Liver Cirrhosis Resulted From Viral Hepatitis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Xijing Hospital of Digestive Diseases · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

There has been great interest in recent years to take advantage of stem cells to treat liver cirrhosis. Mesenchymal stem cells (MSC) has been shown to be safe and effective for liver diseases in some studies. Randomization controlled studies are needed to confirm the long term effect of MSC treatment for liver cirrhosis. This study aimed to investigate the safety and efficacy of mesenchymal stem cells in hepatitis B and C related liver cirrhosis patients. This study is an open-label multicenter randomized control study. Patients with with decompensated cirrhosis will be randomly assigned to receive MSC treatment plus standard medical care(treatment）or standard medical care (control). Three times of MSC infusion (1x10E6 cells/kg body weight) via peripheral vein will be given to the experimental group (once in 4 weeks). The primary outcome is absolute change in liver function indexes and and scores. Secondary outcomes are cirrhosis-related complications, symptoms, life quality, and survival.

Conditions

• Liver Cirrhosis

Interventions

Type	Name	Description
PROCEDURE	mesenchymal stem cell transplantation via peripheral vein	1x10E6 MSCs/kg body weight will be administered via peripheral vein for 3 times at week 0, 4 and 8
OTHER	mesenchymal stem cell	mesenchymal stem cell infusion produced by Cell products of National Engineering Research Center(short for CPNERC), Tianjin, China

Timeline

• Start date: 2017-11-08
• Primary completion: 2019-06-30
• Completion: 2019-12-31
• First posted: 2017-07-06
• Last updated: 2018-09-11

Locations

1 site across 1 country: China