Trial of Mesenchymal Stem Cell Transplantation in Decompensated Liver Cirrhosis

Liver Cirrhosis Clinical Trial

Official title:

Randomized Control Trial of Mesenchymal Stem Cell Transplantation in Decompensated Liver Cirrhosis Resulted From Viral Hepatitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03209986
• Other study ID #: XJMSC0001
• Status: Recruiting
• Phase: N/A
• Start date: November 8, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2018
• Source: Xijing Hospital of Digestive Diseases
• Contact: Changcun Guo, MD
• Phone: 862984771539
• Email: guochc[@]fmmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Aged 18-65 years

2. HBV -related liver cirrhosis

3. Child-Pugh score =7

4. With presentations of decompensation

5. Written consent

Exclusion Criteria:

1. Hepatocellular carcinoma or other malignancies

2. Severe problems in other vital organs(e.g.the heart,renal or lungs)

3. Pregnant or lactating women

4. Severe bacteria infection

5. Anticipated with difficulty of follow-up observation

6. Coinfection with HIV or other viral hepatitis.

7. Drug abuse or alcohol abuse

8. History of severe allergy to biological products

9. Other candidates who are judged to be not applicable to this study by doctors -

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis

Intervention

Procedure:
• mesenchymal stem cell transplantation via peripheral vein
1x10E6 MSCs/kg body weight will be administered via peripheral vein for 3 times at week 0, 4 and 8

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

Locations

Country	Name	City	State
China	Xijing Hospital of Digestive Disease, Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital of Digestive Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Safety: Adverse events as assessed according to CTCAE 4.03	Adverse events as assessed according to CTCAE 4.03	1 year
Secondary	Survival Benefit: Survival Rate at different time points	survival rate at different time points	1 year, 2 year and 5 years
Secondary	Histological change of the liver: Histological scores assessed by liver biopsy	histological scores assessed by liver biopsy at baseline and after treatment	1 year, 2 year and 5 years
Secondary	Clinical benefit: Incidences of cirrhosis-related complications such as GI bleeding, ascites, hepatorenal syndrome, hepatoencephalopathy	Incidences of cirrhosis-related complications such as GI bleeding, ascites, hepatorenal syndrome, hepatoencephalopathy	1, 2 and 5 years