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

Not Applicable

• Conditions: Acute-On-Chronic Liver Failure
• Interventions: Procedure: mesenchymal stem cell transplantation or placebo infusion via peripheral vein

• Registration Number: NCT03668171
• Lead Sponsor: Xijing Hospital of Digestive Diseases

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-10
• Status Verified: 2018-09
• Study First Submitted: 2018-09-10
• Study First Submitted QC: 2018-09-10
• Last Update Submitted: 2018-09-10
• Study First Posted: 2018-09-12
• Last Update Posted: 2018-09-12
• Primary Completion: 2019-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Age between 18-70 years old
• Meeting the criteria of ACLF defined as: 1. definitive chronic liver diseases, acute decompensation within 4 weeks; 2. Significant GI symptom as such fatigue, jaundice,; 3. total bilirubin (TBIL) ≥170 µmo1/L or daily increase of TBIL ≥17.1 µmo1/L; 4. PTA≤40% or INR≥ 1.5; 5. Decompensation of liver functions such as ascites or hepatoencephalopathy;
• MELD score between 17-30. (MELD(i) = 0.957 × ln(Cr) + 0.378 × ln(bilirubin) + 1.120 × ln(INR) + 0.643)
• Chronic liver disease with definitive etiology such as viral hepatitis, alcohol liver disease, drug induced liver injury or autoimmune liver diseases
• Informed consent

Exclusion Criteria

• Sever complications with 30 days ( GI bleeding, severe infection)；

  --liver cancer or other malignancies

• patients on liver transplantation list

• patients with uncontrolled infections

• severe renal failure

• Severe chronic obstructive pulmonary disease COPD (GOLD III-IV)

• Extrahepatic cholanstasis patients due to biliary obstruction.

• HIV infection

• Pregnant or breast-feeding females.

• Enrolled in other clinical trials with 3 months

• other conditions considered inappropriate for the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MSC group	mesenchymal stem cell transplantation or placebo infusion via peripheral vein	mesenchymal stem cell transplantation via peripheral vein: 0.1-1x10E6 MSCs/kg body weight administered via peripheral vein at week 0, 1, 2 weeks
control	mesenchymal stem cell transplantation or placebo infusion via peripheral vein	placebo infusions (placebo infusion differs from the experimental infusion in only that placebo has no mesenchymal stem cells) will be administered via peripheral vein at week 0, 1, 2

Primary Outcome Measures

Name	Time	Method
Efficacy: 12 week mortality rate	12 weeks	mortality rate assessed at week 12

Secondary Outcome Measures

Name	Time	Method
Clinical remission rate at week 12	12 weeks	Clinical remission define as: significant improvement of symptoms and resolution of hepatoencephalopathy; TBIL decrease to below 5 times of ULN，PTA\>40% or INR\<1.6

Trial Locations

Locations (1)

Changcun Guo; 🇨🇳 Xi'an, Shaanxi, China