UC-MSC Infusion for HBV-Related Acute-on-Chronic Liver Failure

NCT02812121 | Unknown Phase 2 DMC

• 2 other identifiers: UCBMSCLBingliang
• Study Type: interventional
• Target: 261
• Locations: 0 countries
• Sites: N/A

Brief Summary

Hepatitis B virus (HBV)-related acute-on-chronic liver failure (ACLF) is a severe disease with high mortality. Our previous study have demonstrated that peripheral infusion of bone marrow-derived mesenchymal stromal cells (MSCs) weekly for 4 times is safe and improves 24 weeks survival rate of ACLF patients. In this study, we intend to assess the safety and efficacy of umbilical cord blood derived MSCs for HBV-related ACLF patients.

Conditions

Liver Failure

Outcome Measures

Primary Outcomes (2)

• The incidence of adverse reactions after umbilical cord blood derived mesenchymal stem cells (UC-MSC) infusions.

  52 weeks

• The survival time of patients after UC-MSC infusions.

  52 weeks

Secondary Outcomes (15)

• The influence on levels of ALT (U/L) and AST (U/L) after UC-MSC infusions

  1,2,3,4,8,12,24,36,52weeks

• The influence on levels of ALB(g/L) after UC-MSC infusions

  1,2,3,4,8,12,24,36,52weeks

• The influence on levels of TBil (umol/L) after UC-MSC infusions

  1,2,3,4,8,12,24,36,52weeks

• The influence on levels of INR after UC-MSC infusions

  1,2,3,4,8,12,24,36,52weeks

• The influence on levels of MELD score, SOFA score and CTP score after UC-MSC infusions

  1,2,3,4,8,12,24,36,52weeks

Study Arms (3)

Group MSC-1

EXPERIMENTAL

Patients in Group MSC-1 received standard medical treatment and infusions of umbilical cord blood mesenchymal stem cells via peripheral veins once a week for 8 weeks.

Drug: umbilical cord blood mesenchymal stem cells

Group MSC-2

EXPERIMENTAL

Patients in Group MSC-1 received standard medical treatment and infusions of umbilical cord blood mesenchymal stem cells via peripheral veins once a week for 4 weeks.

Drug: umbilical cord blood mesenchymal stem cells

Group Control

NO INTERVENTION

Patients in Group Control received standard medical treatment, including bed rest, nutritional supplementation, administration of human serum albumin (10g per day until serum albumin was 35g/L) and plasma (200 ml to 400 ml per day until the international normalized ratio was less than 1.5), anti-viral therapy, glycyrrhizin,S-adenosylmethionine and appropriate treatment for complications (such as infection, encephalopathy, hepatorenal syndrome and intestinal paralysis).

Interventions

umbilical cord blood mesenchymal stem cells DRUG

Group MSC-1; Group MSC-2

Eligibility Criteria

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

You may qualify if:

• Patients with ACLF-which is characterized by acute hepatic insult manifesting as jaundice (serum total bilirubin ≥ 10×ULN umol/L) and coagulopathy (international normalized ratio≥ 1.5 or prothrombin activity \< 40%), complicated within 4 weeks by ascites and/or encephalopathy as determined by physical examination, in patients with previously diagnosed or undiagnosed chronic liver disease;
• Positive serum hepatitis B surface antigen (HBsAg) for more than 6 months;
• End-stage liver disease scores ranging from 17-30,; 4.18-65 years of age.

You may not qualify if:

• Serious complications within the previous 2 months (e.g. gastrointestinal bleeding, serious infection );
• Concomitant autoimmune disease;
• Superinfection with other hepatitis viruses;
• Important organ dysfunctions not due to liver disease or malignancies;
• Pregnancy and lactation;
• Liver tumor or nodules secondary to cirrhosis proven by ultrasound, computerized tomography (CT), or magnetic resonance (MR) imaging;
• Bioartificial liver support therapy;
• Previous liver transplantation.

Sponsors & Collaborators

• Sun Yat-sen University: lead

MeSH Terms

Conditions

Liver Failure

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 27, 2016
• First Posted: June 24, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2018
• Last Updated: June 24, 2016

Record last verified: 2016-06