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

Primary Purpose

Decompensated Cirrhosis

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Conventional therapy
Injectable Collagen Scaffold + HUC-MSCs
Sponsored by
Chinese Academy of Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Decompensated Cirrhosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Conventional therapy

Injectable Collagen Scaffold + HUC-MSCs

Arm Description

Outcomes

Primary Outcome Measures

Improvement of liver function measured by change in the model for end-stage liver disease (MELD) score

Secondary Outcome Measures

Improvement of liver function measured by change in Child-Pugh score
Change in clinical laboratory parameters of liver function
The liver function tests included serum Albumin (Alb), Cholesterol, Cholinesterase (CHE), prothrombin activity.
30-Day Survival
Patients surviving more than 30 days after study registration.
Change in the size of liver and spleen and inner diameter of spleen portal venous

Full Information

First Posted
May 25, 2016
Last Updated
January 9, 2020
Sponsor
Chinese Academy of Sciences
Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT02786017
Brief Title
Injectable Collagen Scaffold™ Combined With HUC-MSCs Transplantation for Patients With Decompensated Cirrhosis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Sciences
Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Decompensated Cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional therapy
Arm Type
Sham Comparator
Arm Title
Injectable Collagen Scaffold + HUC-MSCs
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Conventional therapy
Intervention Description
Patients will receive the conventional therapy.
Intervention Type
Biological
Intervention Name(s)
Injectable Collagen Scaffold + HUC-MSCs
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement of liver function measured by change in the model for end-stage liver disease (MELD) score
Time Frame
1 week, 2 week, 1, 3, 6, 12, 24 month after intervention
Secondary Outcome Measure Information:
Title
Improvement of liver function measured by change in Child-Pugh score
Time Frame
1 week, 2 week, 1, 3, 6, 12, 24 month after intervention
Title
Change in clinical laboratory parameters of liver function
Description
The liver function tests included serum Albumin (Alb), Cholesterol, Cholinesterase (CHE), prothrombin activity.
Time Frame
1 day, 3 day, 1 week, 2 week, 1, 3, 6, 12, 24 month after intervention
Title
30-Day Survival
Description
Patients surviving more than 30 days after study registration.
Time Frame
30 days
Title
Change in the size of liver and spleen and inner diameter of spleen portal venous
Time Frame
1 week, 2 week, 1, 3, 6, 12, 24 month after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhifeng Xiao, Ph.D
Phone
86-10-82614420
Email
zfxiao@genetics.ac.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Sufang Han, Ph.D
Phone
86-10-82614420
Email
sufanghan22@genetics.ac.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianwu Dai, Ph.D
Organizational Affiliation
Chinese Academy of Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaolei Shi, M.D.
Phone
86-25-83304616
Ext
11901
Email
njsxl2000@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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