Safety and Efficacy of SHED for Decompensated Liver Cirrhosis

Naval Military Medical University

Status and phase: Unknown; Early Phase 1

Conditions: Liver Cirrhosis

Treatments: Biological: SHED group

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03957655

SHED01

Details and patient eligibility

About

This study is an prospective, randomized control study. Patients with decompensated cirrhosis will be randomly assigned to receive 4 times of SHED treatment plus standard medical care(treatment）or standard medical care (control). The primary outcome is MELD-Na score. Secondary outcomes are Child-Pugh, liver function, life quality and survival.

Full description

At present, there is still no effective treatment for liver cirrhosis, and the use of stem cells for the treatment of cirrhosis has caused great concern.Stem cells from human exfoliated deciduous teeth (SHED) has been shown to be safe and effective for liver diseases. Randomization controlled studies are needed to confirm the long term effect of SHED treatment for liver cirrhosis. The present study aimed to investigate the safety and efficacy of SHED in hepatitis B related liver cirrhosis patients.

This study is an prospective, randomized control study. Patients with decompensated cirrhosis will be randomly assigned to receive 4 times of SHED treatment plus standard medical care(treatment）or standard medical care (control). SHED infusion (1x10E6 cells/kg body weight) via peripheral vein will be given at week 0,4,8,12.The primary outcome is MELD-Na score. Secondary outcomes are Child-Pugh, liver function, life quality and survival.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Aged 18-70 years
2. HBV-related liver cirrhosis with presentations of decompensation
3. Antiviral treatment with nucleotide drugs for more than half a year and HBV DNA is less than the minimum detection limit;
4. Child-Pugh score B and MELD-Na score≤25
5. Written consent

Exclusion criteria

1. Hepatic encephalopathy, hepatorenal syndrome, acute phase of severe hepatitis
2. Child-Pugh score A or C
3. Hepatocellular carcinoma or other malignancies
4. Cirrhosis or liver failure caused by non-Hepatitis B
5. Pregnancy or breastfeeding
6. Severe bacteria infection,coinfection with HIV or other viral hepatitis.
7. History of severe allergy to biological products or history of immunization within half a year
8. Patients or family members refused to participate in the study
9. Drug abuse or alcohol abuse
10. 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

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40 participants in 2 patient groups

SHED group

Experimental group

Description:

SHED transplantation via peripheral vein: 1x10E6 SHEDs/kg body weight administered via peripheral vein at week 0,4,8,12.

Treatment:

Biological: SHED group

Control

No Intervention group

Description:

Standard medication for viral hepatitis and cirrhosis