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

Sun Yat-sen University

Status and phase: Unknown; Phase 2

Conditions: Liver Failure

Treatments: Drug: umbilical cord blood mesenchymal stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT02812121

UCBMSC

LBingliang (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 261 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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261 participants in 3 patient groups

Group MSC-1

Experimental group

Description:

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.

Treatment:

Drug: umbilical cord blood mesenchymal stem cells

Group MSC-2

Experimental group

Description:

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.

Treatment:

Drug: umbilical cord blood mesenchymal stem cells

Group Control

No Intervention group

Description:

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).