Back to resultsSafety and Efficacy Study of Co-transfering of Mesenchymal Stem Cell and Regulatory T Cells in Treating End-stage Liver Disease
Primary Purpose
Liver Cirrhosis
Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
MSC and Tregs
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cirrhosis
Eligibility Criteria
Inclusion Criteria:
- Clinically diagnosed as decompensated liver cirrhosis.
- Hepatitis B/C Liver Cirrhosis After Viral Treatment, HBV/HCV Viral Loads Below Detection Level over six mouths, and the liver function remained below Child-pugh A grade or MELD score >10.
- Other causes of cirrhosis, liver function compensatory incomplete. In the past year, despite active medical treatment taken, the condition has continued to increase, at least because of cirrhosis complications such as ascites, spontaneous peritonitis, gastrointestinal bleeding, and hepatic encephalopathy in hospital over one time.
- Need to intermittently supplement albumin and apply diuretic therapy.
- Albumin <35 g/L, total bilirubin <170 umol/L, prothrombin activity> 30%; (Prothrombin time <20 s, moderate or lower mass ascites, spontaneous peritonitis and hepatic encephalopathy (grade II or lower), Child-pugh score> 5 points).
- There was no history of gastrointestinal hemorrhage within the last month and population with no high-risk portal hypertension and gastrointestinal bleeding was evaluated recently.
- Unconditional acceptance of orthotopic liver transplantation.
- Aged from 18 to 65 years.
- Voluntarily signed informed consent form.
Exclusion Criteria:
- A malignant tumor with liver or other organs or a history of previous cancer.
- Complications include gastrointestinal bleeding, spontaneous peritonitis, hepatic encephalopathy, hepatorenal syndrome, and Acute infection episodes.
- Patients with severe heart, lung, kidney or blood system diseases and failure status.
- Pregnant or lactating women.
- Allergic constitution.
- There is a history of alcohol abuse, drug abuse, and failure to effectively quit.
- Patients did not participate in other clinical trials within 4 weeks.
- Any condition, investigator believe that patients should not participate in this study.
Sites / Locations
- Nanjing Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Conventional plus MSC and Tregs treatment
Arm Description
Outcomes
Primary Outcome Measures
Albumin (ALB)
The evaluation of serum levels of ALB
Alanine aminotransferase (ALT)
The evaluation of serum levels of ALT
Prealbumin (PA)
The evaluation of serum levels of PA
Total bilirubin (TB)
The evaluation of serum levels of TB
Direct bilirubin (DB)
The evaluation of serum levels of DB
Blood urea nitrogen (BUN)
The evaluation of serum levels of BUN
Uric acid (UA)
The evaluation of serum levels of UA
Serum creatinine (Scr)
The evaluation of serum levels of Scr
Secondary Outcome Measures
Child-Pugh
The evaluation of Child-Pugh score for liver function
Model for end-stage liver disease (MELD)
The evaluation of MELD score for severity of liver disease
Quality of life (QOL)
The evaluation of QOL score for life quality
Full Information
NCT ID
NCT03460795
First Posted
February 23, 2018
Last Updated
March 1, 2020
Sponsor
Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03460795
Brief Title
Safety and Efficacy Study of Co-transfering of Mesenchymal Stem Cell and Regulatory T Cells in Treating End-stage Liver Disease
Official Title
Phase 1 Clinical Trial Using Mesenchymal Stem Cell and Regulatory T Cells as Individualized Medicine to Evaluate the Safety and Efficacy in End-stage Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2020 (Anticipated)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Cirrhosis of the liver is a common clinical chronic progressive liver disease, which is a diffuse liver lesion caused by one or more causes over a long period of time or repeatedly. Nodules, abnormal spherical areas of cells, form as dying liver cells are replaced by regenerating cells. This regeneration of cells causes the liver to become hard. The potential for stem cells to differentiate into hepatocytes cells was recently confirmed. In particular, mesenchymal stem cell (MSC) transplantation has been applicated in the clinic for treat several human diseases such as liver injury and liver fibrosis displayed good tolerance and efficiency. Besides, regulatory T cells(Tregs) had been proved as an immune regualtory T cell subsets, which could reduce immune cell activation and reduce liver injury severity. The purpose of this study is to learn whether and how MSCs and Tregs can improve the disease conditions in patients with decompensated cirrhosis.
Detailed Description
Cirrhosis of the liver is a common clinical chronic progressive liver disease, which is a diffuse liver lesion caused by one or more causes over a long period of time or repeatedly. Nodules, abnormal spherical areas of cells, form as dying liver cells are replaced by regenerating cells. This regeneration of cells causes the liver to become hard. Decompensated liver cirrhosis is mainly manifested by liver function damage and portal hypertension, with multiple system involvement. Complications such as upper gastrointestinal hemorrhage, hepatic encephalopathy, secondary infection, hypersplenism, ascites, and carcinogenesis often occur in the late stage. The potential for stem cells to differentiate into hepatocytes cells was recently confirmed. In particular, mesenchymal stem cell (MSC) and Tregs transplantation had been applicated in the clinic for treat several human diseases such as liver injury and liver fibrosis displayed good tolerance and efficiency. The purpose of this study is to learn whether and how MSCs and Tregs can improve the disease conditions in patients with decompensated cirrhosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional plus MSC and Tregs treatment
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
MSC and Tregs
Intervention Description
conventional plus MSC and Tregs or placebo treatment
Primary Outcome Measure Information:
Title
Albumin (ALB)
Description
The evaluation of serum levels of ALB
Time Frame
24 months
Title
Alanine aminotransferase (ALT)
Description
The evaluation of serum levels of ALT
Time Frame
24 months
Title
Prealbumin (PA)
Description
The evaluation of serum levels of PA
Time Frame
24 months
Title
Total bilirubin (TB)
Description
The evaluation of serum levels of TB
Time Frame
24 months
Title
Direct bilirubin (DB)
Description
The evaluation of serum levels of DB
Time Frame
24 months
Title
Blood urea nitrogen (BUN)
Description
The evaluation of serum levels of BUN
Time Frame
24 months
Title
Uric acid (UA)
Description
The evaluation of serum levels of UA
Time Frame
24 months
Title
Serum creatinine (Scr)
Description
The evaluation of serum levels of Scr
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Child-Pugh
Description
The evaluation of Child-Pugh score for liver function
Time Frame
24 months
Title
Model for end-stage liver disease (MELD)
Description
The evaluation of MELD score for severity of liver disease
Time Frame
24 months
Title
Quality of life (QOL)
Description
The evaluation of QOL score for life quality
Time Frame
24 months
Other Pre-specified Outcome Measures:
Title
Evaluation of liver fibrosis
Description
The pathology decrease in grade of liver fibrosis
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Clinically diagnosed as decompensated liver cirrhosis.
Hepatitis B/C Liver Cirrhosis After Viral Treatment, HBV/HCV Viral Loads Below Detection Level over six mouths, and the liver function remained below Child-pugh A grade or MELD score >10.
Other causes of cirrhosis, liver function compensatory incomplete. In the past year, despite active medical treatment taken, the condition has continued to increase, at least because of cirrhosis complications such as ascites, spontaneous peritonitis, gastrointestinal bleeding, and hepatic encephalopathy in hospital over one time.
Need to intermittently supplement albumin and apply diuretic therapy.
Albumin <35 g/L, total bilirubin <170 umol/L, prothrombin activity> 30%; (Prothrombin time <20 s, moderate or lower mass ascites, spontaneous peritonitis and hepatic encephalopathy (grade II or lower), Child-pugh score> 5 points).
There was no history of gastrointestinal hemorrhage within the last month and population with no high-risk portal hypertension and gastrointestinal bleeding was evaluated recently.
Unconditional acceptance of orthotopic liver transplantation.
Aged from 18 to 65 years.
Voluntarily signed informed consent form.
Exclusion Criteria:
A malignant tumor with liver or other organs or a history of previous cancer.
Complications include gastrointestinal bleeding, spontaneous peritonitis, hepatic encephalopathy, hepatorenal syndrome, and Acute infection episodes.
Patients with severe heart, lung, kidney or blood system diseases and failure status.
Pregnant or lactating women.
Allergic constitution.
There is a history of alcohol abuse, drug abuse, and failure to effectively quit.
Patients did not participate in other clinical trials within 4 weeks.
Any condition, investigator believe that patients should not participate in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ling Lu, M.D, PH.D
Phone
86-025-68136053
Email
lvling@njmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinhai Tang, M.D, PH.D
Organizational Affiliation
Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ling Lu, M.D, PH. D.
Phone
86-025-68136053
Email
lvling@njmu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of Co-transfering of Mesenchymal Stem Cell and Regulatory T Cells in Treating End-stage Liver Disease
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