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

NCT03668171 | Unknown

• 1 other identifier: KY20172049-1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

Acute-On-Chronic Liver Failure, mesenchymal stem cell,

Outcome Measures

Primary Outcomes (1)

• Efficacy: 12 week mortality rate

  mortality rate assessed at week 12

  12 weeks

Secondary Outcomes (1)

• Clinical remission rate at week 12

  12 weeks

Study Arms (2)

MSC group

EXPERIMENTAL

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

Procedure: mesenchymal stem cell transplantation or placebo infusion via peripheral vein

control

PLACEBO COMPARATOR

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

Procedure: mesenchymal stem cell transplantation or placebo infusion via peripheral vein

Interventions

mesenchymal stem cell transplantation or placebo infusion via peripheral vein 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

MSC group; control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (1)

Changcun Guo

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure

Interventions

Mesenchymal Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Central Study Contacts

Ying Han, MD

CONTACT

862984771539; guochc@fmmu.edu.cn

Changcun Guo

CONTACT

13991900180; guochc@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization will be blinded to participant, care provider, investigator and outcome assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 12, 2018
• Study Start: December 10, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: September 12, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: within 12 months after the study completion and before publications of the findings.

Locations

CN (1)