Liver Cirrhosis
Conditions
Keywords
Liver Cirrhosis, stem cell, therapy
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.
Interventions
BIOLOGICALSHED group
1x10E6 MSCs/kg body weight will be administered via peripheral vein for 4 times at week 0,4,8,12
Sponsors
Eastern Hepatobiliary Surgery Hospital
CAR-T (Shanghai) Biotechnology Co., Ltd.
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors will be blind to the randomization results of the participants.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Changes of liver function | baseline and 4,8,12,16,24 week | Changes of liver function index such as ALT, AST, ALB, TBIL, PT |
| Changes of life quality | baseline and 4,8,12,16,24 week | Changes of life quality as assessed by SF-36 |
| Survival Rate at half of one year | half of one year | Survival rate at half of one year |
Countries
China
Contacts
Primary ContactLei Xin, Dr.
Outcome results
None listed