Trial of Mesenchymal Stem Cell Transplantation in Decompensated Liver Cirrhosis

NCT03209986 | Unknown

• 1 other identifier: XJMSC0001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

There has been great interest in recent years to take advantage of stem cells to treat liver cirrhosis. Mesenchymal stem cells (MSC) has been shown to be safe and effective for liver diseases in some studies. Randomization controlled studies are needed to confirm the long term effect of MSC treatment for liver cirrhosis. This study aimed to investigate the safety and efficacy of mesenchymal stem cells in hepatitis B and C related liver cirrhosis patients. This study is an open-label multicenter randomized control study. Patients with with decompensated cirrhosis will be randomly assigned to receive MSC treatment plus standard medical care(treatment）or standard medical care (control). Three times of MSC infusion (1x10E6 cells/kg body weight) via peripheral vein will be given to the experimental group (once in 4 weeks). The primary outcome is absolute change in liver function indexes and and scores. Secondary outcomes are cirrhosis-related complications, symptoms, life quality, and survival.

Conditions

Liver Cirrhosis

Keywords

Liver Cirrhosis; Mesenchymal Sem Cells

Outcome Measures

Primary Outcomes (2)

• Efficacy: Change of liver functions as assessed by MELD score

  Change of liver functions as assessed by MELD score (MELD, Model for End-Stage Liver Disease Score: MELD = 3.78×ln\[serum bilirubin (mg/dL)\] + 11.2×ln\[INR\] + 9.57×ln\[serum creatinine (mg/dL)\] + 6.43)

  1 year

• Safety: Adverse events as assessed according to CTCAE 4.03

  Adverse events as assessed according to CTCAE 4.03

  1 year

Secondary Outcomes (3)

• Survival Benefit: Survival Rate at different time points

  1 year, 2 year and 5 years

• Histological change of the liver: Histological scores assessed by liver biopsy

  1 year, 2 year and 5 years

• Clinical benefit: Incidences of cirrhosis-related complications such as GI bleeding, ascites, hepatorenal syndrome, hepatoencephalopathy

  1, 2 and 5 years

Study Arms (2)

MSC group

EXPERIMENTAL

mesenchymal stem cell transplantation via peripheral vein: 1x10E6 MSCs/kg body weight administered via peripheral vein at week 0, 4, 8.

Procedure: mesenchymal stem cell transplantation via peripheral vein; Other: mesenchymal stem cell

control

NO INTERVENTION

Standard medication for viral hepatitis and cirrhosis

Interventions

mesenchymal stem cell transplantation via peripheral vein PROCEDURE

1x10E6 MSCs/kg body weight will be administered via peripheral vein for 3 times at week 0, 4 and 8

MSC group

mesenchymal stem cell OTHER

mesenchymal stem cell infusion produced by Cell products of National Engineering Research Center(short for CPNERC), Tianjin, China

MSC group

Eligibility Criteria

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

You may qualify if:

• Aged 18-65 years
• HBV -related liver cirrhosis
• Child-Pugh score ≥7
• With presentations of decompensation
• Written consent

You may not qualify if:

• Hepatocellular carcinoma or other malignancies
• Severe problems in other vital organs(e.g.the heart,renal or lungs)
• Pregnant or lactating women
• Severe bacteria infection
• Anticipated with difficulty of follow-up observation
• Coinfection with HIV or other viral hepatitis.
• Drug abuse or alcohol abuse
• History of severe allergy to biological products
• Other candidates who are judged to be not applicable to this study by doctors -

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (1)

Xijing Hospital of Digestive Disease, Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Changcun Guo, MD

CONTACT

862984771539; guochc@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blind to the randomization results of the participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Physician, Professor

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 6, 2017
• Study Start: November 8, 2017
• Primary Completion: June 30, 2019
• Study Completion: December 31, 2019
• Last Updated: September 11, 2018

Record last verified: 2018-09

Locations

CN (1)