Injectable Collagen Scaffold™ Combined With HUC-MSCs Transplantation for Patients With Decompensated Cirrhosis

Study Overview
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Brief Summary
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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.

Official Title
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The Safety and Efficacy Assessment of Injectable Collagen Scaffold™ Combined With Human Umbilical Cord-derived Mesenchymal Stem Cells (HUC-MSCs) Transplantation in Patients With Decompensated Cirrhosis

Conditions
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Decompensated Cirrhosis

Intervention / Treatment
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* Biological: Conventional therapy
* Biological: Injectable Collagen Scaffold + HUC-MSCs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must meet all of the following criteria: Subjects who are decompensated cirrhosis of any cause. 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). Need intermittent plasma albumin and oral diuretics supplement. 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. Peripheral blood hemoglobin concentration> 70g/L，platelet count > 3 × 10^9/L, hematocrit (HCT) level>0.25. No gastrointestinal bleeding during the last one month before enrolment. Patient has no conditional to undergo orthotopic liver transplantation (OLT). Willing to sign informed consent. Exclusion Criteria: Participants CANNOT meet any of the following criteria: The presence of hepatocellular carcinoma (HCC) or other malignant tumors. Complicated with gastrointestinal bleeding, spontaneous bacterial peritonitis, hepatic encephalopathy, hepatorenal syndrome and acute exacerbation of infection. Presence of severe comorbid diseases (e.g., severe renal, respiratory, cardiac or blood disease). Pregnant or lactating women. Allergy to G-CSF, contrast agents and anticoagulants. Alcoholism or drug abuse.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Conventional therapy<br> | Biological: Conventional therapy<br>* Patients will receive the conventional therapy.<br>|
| Experimental: Injectable Collagen Scaffold + HUC-MSCs<br> | Biological: Injectable Collagen Scaffold + HUC-MSCs<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | The liver function tests included serum Albumin (Alb), Cholesterol, Cholinesterase (CHE), prothrombin activity. | 1 day, 3 day, 1 week, 2 week, 1, 3, 6, 12, 24 month after intervention | 
| 30-Day Survival | Patients surviving more than 30 days after study registration. | 30 days | 
| 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 |