Trial of Mesenchymal Stem Cell Transplantation in Decompensated Liver Cirrhosis

Xijing Hospital of Digestive Diseases

Status: Unknown

Conditions: Liver Cirrhosis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03209986

XJMSC0001

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

200 participants in 2 patient groups

MSC group

Experimental group

Description:

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

Treatment:

Other: mesenchymal stem cell

Procedure: mesenchymal stem cell transplantation via peripheral vein

control

No Intervention group

Description:

Standard medication for viral hepatitis and cirrhosis