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

NCT ID: NCT02812121

Last Updated: 2016-06-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 261 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2018-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group MSC-1

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.

Group Type: EXPERIMENTAL

umbilical cord blood mesenchymal stem cells

Intervention Type: DRUG

Group MSC-2

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.

Group Type: EXPERIMENTAL

umbilical cord blood mesenchymal stem cells

Intervention Type: DRUG

Group Control

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

umbilical cord blood mesenchymal stem cells

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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;

2. Positive serum hepatitis B surface antigen (HBsAg) for more than 6 months;

3. End-stage liver disease scores ranging from 17-30,; 4.18-65 years of age.

Exclusion Criteria

1. Serious complications within the previous 2 months (e.g. gastrointestinal bleeding, serious infection );

2. Concomitant autoimmune disease;

3. Superinfection with other hepatitis viruses;

4. Important organ dysfunctions not due to liver disease or malignancies;

5. Pregnancy and lactation;

6. Liver tumor or nodules secondary to cirrhosis proven by ultrasound, computerized tomography (CT), or magnetic resonance (MR) imaging;

7. Bioartificial liver support therapy;

8. Previous liver transplantation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Lin Bingliang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

LBingliang

Identifier Type: REGISTRY

Identifier Source: secondary_id

UCBMSC

Identifier Type: -

Identifier Source: org_study_id