NCT03529136

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

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: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 252 (estimated)
• Sponsor: Shandong Qilu Stem Cells Engineering Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Decompensated Liver Cirrhosis

Interventions

Type	Name	Description
BIOLOGICAL	UC-MSC	Human umbilical cord mesenchymal stem cells have driven from Wharton's jelly and cultured with serum-free medium in Shandong Cell and tissue bank. All of the cells in this study within three passages. Before transfusion, the mesenchymal stem cells were subjected to quality control. The UC-MSC were stained with anti-CD90-FITC, Anti-CD44-FITC, Anti-CD34-FITC and anti-45-FITC.

Timeline

• Start date: 2018-06-01
• Primary completion: 2019-12-31
• Completion: 2020-04-30
• First posted: 2018-05-18
• Last updated: 2018-05-18