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

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

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.

Study Overview

• Status: Unknown
• Conditions: Decompensated Cirrhosis
• Intervention / Treatment: Biological: Conventional therapy; Biological: Injectable Collagen Scaffold + HUC-MSCs

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
      • Contact: Xiaolei Shi, M.D.; Phone Number: 11901 86-25-83304616; Email: njsxl2000@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 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

Collaborators and Investigators

• Sponsor: Chinese Academy of Sciences
• Collaborators: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: May 25, 2016
• First Submitted That Met QC Criteria: May 25, 2016
• First Posted (Estimate): May 30, 2016

Study Record Updates

• Last Update Posted (Actual): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 9, 2020
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: CAS-XDA-DC/IGDB