Acute-On-Chronic Liver Failure
Conditions
Keywords
Acute-On-Chronic Liver Failure, mesenchymal stem cell,
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.
Interventions
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
Sponsors
Xijing Hospital of Digestive Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Randomization will be blinded to participant, care provider, investigator and outcome assessors.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy: 12 week mortality rate | 12 weeks | mortality rate assessed at week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactYing Han, MD
Backup ContactChangcun Guo
Outcome results
None listed