Decompensated Cirrhosis
Conditions
Brief summary
The purpose of this study is to assess the safety and efficacy of injectable collagen scaffold combined with human umbilical cord-derived mesenchymal stem cells (HUC-MSCs) transplantation in patients with Decompensated Cirrhosis.
Interventions
BIOLOGICALConventional therapy
Patients will receive the conventional therapy.
BIOLOGICALInjectable Collagen Scaffold + HUC-MSCs
Injectable collagen scaffold combined with HUC-MSCs was injected into left lateral segment, left medial segment, right anterior segment, right posterior segment and caudate lobe under B-mode ultrasound supervision, respectively. The total amount of HUC-MSCs was 5\*10\^8.
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Chinese Academy of Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants must meet all of the following criteria: 1. Subjects who are decompensated cirrhosis of any cause. 2. Subjects are repeated exacerbations despite treatment and hospitalized more than once within one year because of complications of cirrhosis, (e.g., massive ascites, spontaneous bacterial peritonitis, gastrointestinal bleeding or hepatic encephalopathy). 3. Need intermittent plasma albumin and oral diuretics supplement. 4. Serum albumin \<35 g/L, total bilirubin\<170 μmol/L, prothrombin activity \>30% (prothrombin time \<20 s), moderate or mild ascites, spontaneous bacterial peritonitis and hepatic encephalopathy have been cured, Child-pugh score ≥7. 5. Peripheral blood hemoglobin concentration\> 70g/L，platelet count \> 3 × 10\^9/L, hematocrit (HCT) level\>0.25. 6. No gastrointestinal bleeding during the last one month before enrolment. 7. Patient has no conditional to undergo orthotopic liver transplantation (OLT). 8. Willing to sign informed consent.
Exclusion criteria
Participants CANNOT meet any of the following criteria: 1. The presence of hepatocellular carcinoma (HCC) or other malignant tumors. 2. Complicated with gastrointestinal bleeding, spontaneous bacterial peritonitis, hepatic encephalopathy, hepatorenal syndrome and acute exacerbation of infection. 3. Presence of severe comorbid diseases (e.g., severe renal, respiratory, cardiac or blood disease). 4. Pregnant or lactating women. 5. Allergy to G-CSF, contrast agents and anticoagulants. 6. Alcoholism or drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of liver function measured by change in the model for end-stage liver disease (MELD) score | 1 week, 2 week, 1, 3, 6, 12, 24 month after intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of liver function measured by change in Child-Pugh score | 1 week, 2 week, 1, 3, 6, 12, 24 month after intervention | — |
| Change in clinical laboratory parameters of liver function | 1 day, 3 day, 1 week, 2 week, 1, 3, 6, 12, 24 month after intervention | The liver function tests included serum Albumin (Alb), Cholesterol, Cholinesterase (CHE), prothrombin activity. |
| 30-Day Survival | 30 days | Patients surviving more than 30 days after study registration. |
| Change in the size of liver and spleen and inner diameter of spleen portal venous | 1 week, 2 week, 1, 3, 6, 12, 24 month after intervention | — |
Countries
China
Contacts
Primary ContactZhifeng Xiao, Ph.D
Backup ContactSufang Han, Ph.D
Outcome results
None listed