Clinical Trial of Umbilical Cord Mesenchymal Stem Cell Transfusion in Decompensated Liver Cirrhosis

Decompensated Liver Cirrhosis Clinical Trial

Official title: A Prospective Multicenter Clinical Study to Evaluate The Safety and Efficiency of Human Umbilical Cord Mesenchymal Stem Cell Transfusion in Patients With Decompensated Liver Cirrhosis.

Status Not yet recruiting

Clinical Trial Summary

Decompensated liver cirrhosis is one of the life-threatening complication of chronic liver disease. Liver transplantation currently is the only effective method that can improve the survival of these patients. However, the severe shortage of donor livers, high cost, and potential serious complications have restricted the availability of liver transplantation.Umbilical cord mesenchymal stem cells (UC-MSC) has been generally shown to be safe and effective for liver diseases in some pre-clinical and clinical studies. This study aim to evaluate the safety and efficiency of human umbilical cord mesenchymal stem cell transfusion in patients with decompensated liver cirrhosis, and explore the best protocol of MSC transfusion.

Clinical Trial Description

This study is a multicenter non randomized control study. Patients with decompensated liver cirrhosis are going to be assigned to receive standard medical care plus UC-MSC treatment with two different protocol (group 1 and group 2) or standard medical care (control). Four times of MSC infusion (1.5x10E6 cells/kg body weight) via peripheral vein will be given to the group 1（once every 4 days), and two times of MSC infusion once every 7 days to the group 2. The primary outcome is survival rates in one year. Secondary outcomes are liver function, liver ascites and MELD score. ;

Related Conditions & MeSH terms

• Decompensated Liver Cirrhosis
• Fibrosis
• Liver Cirrhosis

• NCT number: NCT03529136
• Study type: Interventional
• Source: Shandong Qilu Stem Cells Engineering Co., Ltd.
• Contact: Xie
• Phone: +86 13256735916
• Email: mm-xie@hotmail.com
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 1, 2018
• Completion date: April 30, 2020