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

Phase 1

• Conditions: Decompensated Cirrhosis
• Interventions: Biological: Injectable Collagen Scaffold + HUC-MSCs; Biological: Conventional therapy

• Registration Number: NCT02786017
• Lead Sponsor: Chinese Academy of Sciences

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-04
• Study Start: 2016-05
• Study First Submitted: 2016-05-25
• Study First Submitted QC: 2016-05-25
• Study First Posted: 2016-05-30
• Last Update Submitted: 2020-01-09
• Last Update Posted: 2020-01-13
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Injectable Collagen Scaffold + HUC-MSCs	Injectable Collagen Scaffold + HUC-MSCs	-
Conventional therapy	Conventional therapy	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China