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

Acute-On-Chronic Liver Failure Clinical Trial

Official title:

Mesenchymal Stem Cell Transplantation for Acute-on-chronic Liver Failure, a Randomized, Double Blind, Placebo Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03668171
• Other study ID #: KY20172049-1
• Status: Recruiting
• Phase: N/A
• Start date: December 10, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: September 2018
• Source: Xijing Hospital of Digestive Diseases
• Contact: Ying Han, MD
• Phone: 862984771539
• Email: guochc[@]fmmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute-On-Chronic Liver Failure
• End Stage Liver Disease
• Liver Failure

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
China	Changcun Guo	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital of Digestive Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: 12 week mortality rate	mortality rate assessed at week 12	12 weeks
Secondary	Clinical remission rate at week 12	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	12 weeks