Safety and Efficacy of SHED for Decompensated Liver Cirrhosis

Early Phase 1

• Conditions: Liver Cirrhosis
• Interventions: Biological: SHED group

• Registration Number: NCT03957655
• Lead Sponsor: Changhai Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-05-19
• Study First Submitted QC: 2019-05-19
• Study First Posted: 2019-05-21
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-01
• Study Start: 2019-12-02
• Last Update Posted: 2019-12-03
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Model for End-Stage Liver Disease (MELD)-Na score	baseline and 4,8,12,16,24 week	The MELD-Na score is a reliable measure of mortality risk in patients with end-stage liver disease.; MELD-Na score=3.8ln\[bilirubin (mg/dl)\]+11.21ln(INR) +9.6ln\[creatinine (mg/dl) +6.4\* (cause: cholestasis and alcoholic cirrhosis are 0, others are 1) +1.59\* (135-Na)

Secondary Outcome Measures

Name	Time	Method
Changes of life quality	baseline and 4,8,12,16,24 week	Changes of life quality as assessed by SF-36
Changes of liver function	baseline and 4,8,12,16,24 week	Changes of liver function index such as ALT, AST, ALB, TBIL, PT
Survival Rate at half of one year	half of one year	Survival rate at half of one year
Child-Pugh score	baseline and 4,8,12,16,24 week	The Child-Pugh score is a scoring system to measure the severity of chronic liver disease inclusive of cirrhosis. The point scores are added up and classified as: class A: 5-6 points class B: 7-9 points class C: 10-15 points; The score is composed from several categories: total bilirubin, μmol/l (mg/dl)\<34: 1 point 34-50: 2 points \>50: 3 points; serum albumin, g/l\>35: 1 point 28-35: 2 points \<28: 3 points; INR\<1.7: 1 point 1.7-2.3: 2 points \>2.3: 3 points; presence of ascites none: 1 point mild: 2 points moderate to severe: 3 points; presence of hepatic encephalopathy none: 1 point grades I-II : 2 point grades III-IV: 3 point

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China