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

Last updated: September 10, 2018
Sponsor: Xijing Hospital of Digestive Diseases
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Failure

Liver Disease

Treatment

N/A

Clinical Study ID

NCT03668171
KY20172049-1
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age between 18-70 years old

  • Meeting the criteria of ACLF defined as: 1. definitive chronic liver diseases, acutedecompensation within 4 weeks; 2. Significant GI symptom as such fatigue, jaundice,;

  1. 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 orhepatoencephalopathy;

  • 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 liverdisease, drug induced liver injury or autoimmune liver diseases

  • Informed consent

Exclusion

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

Total Participants: 200
Study Start date:
December 10, 2017
Estimated Completion Date:
December 31, 2020

Connect with a study center

  • Changcun Guo

    Xi'an, Shaanxi 710032
    China

    Active - Recruiting

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