Umbilical Cord Mesenchymal Stem Cells Transplantation Combined With Plasma Exchange for Patients With Liver Failure

Phase 1

• Conditions: Liver Failure
• Interventions: Other: Conventional treatment; Other: Conventional plus UC-MSC treatment; Other: Conventional plus PE treatment; Other: Conventional plus UC-MSC and PE therapy

• Registration Number: NCT01724398
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

Brief Summary

Liver failure (LF) is a dramatic clinical syndrome with massive necrosis of liver cells. Although liver transplantation provides an option to cure patients suffering with LF, lack of donors, postoperative complications, especially rejection, and high cost limit its application. Previous study showed that bone marrow derived mesenchymal stem cells (BM-MSCs) the novel and promising therapeutic strategy, BM-MSCs can replace hepatocytes in injured liver, and effectively rescue experimental liver failure and contribute to liver regeneration. Plasma exchange (PE) can improve internal environment by removing endotoxin, it helps the liver regeneration and functional recovery and make UC-MSC differentiation into hepatocyte like cells, and exert immunomodulatory function. In this study, safety and efficacy of human umbilical cord mesenchymal stem cells (UC-MSCs) transplantation combined with plasma exchange (PE) for patients with liver failure caused by hepatitis B Virus will be evaluated.

Detailed Description

To investigate safety and efficacy of human umbilical cord mesenchymal stem cells (UC-MSCs) transplantation combined with plasma exchange (PE) for patients with liver failure caused by hepatitis B virus.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-04
• Study First Submitted QC: 2012-11-06
• Study First Posted: 2012-11-09
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-27
• Last Update Posted: 2013-02-28
• Primary Completion: 2015-03
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Written informed consent
• Acute-on-Chronic liver failure caused by hepatitis B virus
• Model for End-Stage Liver Disease (MELD) <30

Exclusion Criteria

• Liver failure caused by other reasons, such as autoimmune diseases, alcohol, drug and so on
• History of severe hepatic encephalopathy or variceal bleeding during the last two months before enrollment
• Severe problems in other vital organs(e.g. the heart, renal or lungs)
• Severe bacteria infection
• Tumor on ultrasonography, CT or MRI examination
• Pregnant or lactating women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional treatment	Conventional treatment	Participants will receive conventional treatment and then be followed until the week 48 study visit.
Conventional plus UC-MSC treatment	Conventional plus UC-MSC treatment	Participants will receive conventional treatment plus a dose of UC-MSC and then be followed until the week 48 study visit.
Conventional plus PE treatment	Conventional plus PE treatment	Participants will receive conventional treatment plus plasma exchange and then be followed until the week 48 study visit.
Conventional plus UC-MSC and PE therapy	Conventional plus UC-MSC and PE therapy	Participants will receive conventional treatment plus umbilical cord mesenchymal stem cells transplantation combined with plasma exchange. Participants will then be followed until the week 48 study visit.

Primary Outcome Measures

Name	Time	Method
Survival rate and time	48 weeks

Secondary Outcome Measures

Name	Time	Method
Improve biochemical indexes [alanine aminotransferase (ALT), albumin (ALB), total bilirubin (TBIL), prothrombin time (PT), INR and so on]	24 weeks after treatment
The clinical symptom improvement [including appetite, debilitation, abdominal distension, edema of lower limbs, et al]	24 weeks after treatment
Liver function evaluation using Child-Pugh score and MELD score	24 weeks after treatment
Immune function improvement [including Th1/Th2]	24 weeks after treatment
The occurrence of complications [including body temperature, tetter and allergy]	Between 0 to 8 hours after UC-MSCs transfusion
Incidence of hepatocellular carcinoma	48 weeks after treatment

Trial Locations

Locations (1)

Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China