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Safety and Efficacy of SHED for Decompensated Liver Cirrhosis

Liver Cirrhosis Clinical Trial

Official title:
Safety and Efficacy of Stem Cells From Human Exfoliated Deciduous Teeth for Treatment of Decompensated Liver Cirrhosis

Clinical Trial Summary

This study is an prospective, randomized control study. Patients with decompensated cirrhosis will be randomly assigned to receive 4 times of SHED treatment plus standard medical care(treatment）or standard medical care (control). The primary outcome is MELD-Na score. Secondary outcomes are Child-Pugh, liver function, life quality and survival.

Clinical Trial Description

At present, there is still no effective treatment for liver cirrhosis, and the use of stem cells for the treatment of cirrhosis has caused great concern.Stem cells from human exfoliated deciduous teeth (SHED) has been shown to be safe and effective for liver diseases. Randomization controlled studies are needed to confirm the long term effect of SHED treatment for liver cirrhosis. The present study aimed to investigate the safety and efficacy of SHED in hepatitis B related liver cirrhosis patients.

This study is an prospective, randomized control study. Patients with decompensated cirrhosis will be randomly assigned to receive 4 times of SHED treatment plus standard medical care(treatment）or standard medical care (control). SHED infusion (1x10E6 cells/kg body weight) via peripheral vein will be given at week 0,4,8,12.The primary outcome is MELD-Na score. Secondary outcomes are Child-Pugh, liver function, life quality and survival. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03957655
Study type Interventional
Source Changhai Hospital
Contact Lei Xin, Dr.
Phone 862131161365
Email aip_xin@163.com
Status Not yet recruiting
Phase Early Phase 1
Start date December 2, 2019
Completion date December 31, 2021
View Details
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