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

NCT ID: NCT03668171

Last Updated: 2018-09-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-10
• Study Completion Date: 2020-12-31

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.

Conditions

Acute-On-Chronic Liver Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

MSC group

mesenchymal stem cell transplantation via peripheral vein: 0.1-1x10E6 MSCs/kg body weight administered via peripheral vein at week 0, 1, 2 weeks

Group Type: EXPERIMENTAL

mesenchymal stem cell transplantation or placebo infusion via peripheral vein

Intervention Type: PROCEDURE

0.1-1x10E6 MSCs/kg body weight will be administered via peripheral vein for 3 times at week 0, 4 and 8 mesenchymal stem cell mesenchymal stem cell infusion produced by Cell products of National Engineering Research Center(short for CPNERC), Tianjin, China For control group, placebo infusions will be given to the participants at the same time points

control

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

Group Type: PLACEBO_COMPARATOR

mesenchymal stem cell transplantation or placebo infusion via peripheral vein

Intervention Type: PROCEDURE

0.1-1x10E6 MSCs/kg body weight will be administered via peripheral vein for 3 times at week 0, 4 and 8 mesenchymal stem cell mesenchymal stem cell infusion produced by Cell products of National Engineering Research Center(short for CPNERC), Tianjin, China For control group, placebo infusions will be given to the participants at the same time points

Interventions

mesenchymal stem cell transplantation or placebo infusion via peripheral vein

0.1-1x10E6 MSCs/kg body weight will be administered via peripheral vein for 3 times at week 0, 4 and 8 mesenchymal stem cell mesenchymal stem cell infusion produced by Cell products of National Engineering Research Center(short for CPNERC), Tianjin, China For control group, placebo infusions will be given to the participants at the same time points

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital of Digestive Diseases

OTHER

Sponsor Role: lead

Responsible Party

Han Ying

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Changcun Guo

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ying Han, MD

Role: CONTACT

guochc@fmmu.edu.cn

862984771539

Changcun Guo

Role: CONTACT

guochc@sina.com

13991900180

Facility Contacts

Changcun Guo

Role: primary

guochc@sina.com

13991900180

Other Identifiers

KY20172049-1

Identifier Type: -

Identifier Source: org_study_id