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

Liver Failure Clinical Trial

Official title:

Umbilical Cord Blood Derived Mesenchymal Stem Cells Infusion for HBV-Related Acute-on-Chronic Liver Failure: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02812121
• Other study ID #: UCBMSC
• Secondary ID: LBingliang
• Status: Not yet recruiting
• Phase: Phase 2
• First received: May 27, 2016
• Last updated: June 21, 2016
• Start date: June 2016
• Est. completion date: June 2018

Study information

• Verified date: June 2016
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 261
• Est. completion date: June 2018
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute-On-Chronic Liver Failure
• End Stage Liver Disease
• Liver Failure

Intervention

Drug:
• umbilical cord blood mesenchymal stem cells

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of adverse reactions after umbilical cord blood derived mesenchymal stem cells (UC-MSC) infusions.		52 weeks	Yes
Primary	The survival time of patients after UC-MSC infusions.		52 weeks	No
Secondary	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	No
Secondary	The influence on levels of ALB(g/L) after UC-MSC infusions		1,2,3,4,8,12,24,36,52weeks	No
Secondary	The influence on levels of TBil (umol/L) after UC-MSC infusions		1,2,3,4,8,12,24,36,52weeks	No
Secondary	The influence on levels of INR after UC-MSC infusions		1,2,3,4,8,12,24,36,52weeks	No
Secondary	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	No
Secondary	The incidence of fatal complications after UC-MSC infusions.		52 weeks	No
Secondary	Comparison of levels of NKG2A among the groups after UC-MSC infusions		2,4,8,12,24,36,52 weeks	No
Secondary	Comparison of levels of NKG2D among the groups after UC-MSC infusions		2,4,8,12,24,36,52 weeks	No
Secondary	Comparison of levels of NKP46 among the groups after UC-MSC infusions		2,4,8,12,24,36,52 weeks	No
Secondary	Comparison of levels of KIR2DL1 among the groups after UC-MSC infusions		2,4,8,12,24,36,52 weeks	No
Secondary	Comparison of levels of KIR2DL3 among the groups after UC-MSC infusions		2,4,8,12,24,36,52 weeks	No
Secondary	Comparison of levels of KIR3DL1 among the groups after UC-MSC infusions		2,4,8,12,24,36,52 weeks	No
Secondary	Comparison of levels of perforin among the groups after UC-MSC infusions		2,4,8,12,24,36,52 weeks	No
Secondary	Comparison of levels of FasL among the groups after UC-MSC infusions		2,4,8,12,24,36,52 weeks	No
Secondary	Comparison of levels of gramzymeB among the groups after UC-MSC infusions		2,4,8,12,24,36,52 weeks	No