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Safety and Efficacy Study of Co-transfering of Mesenchymal Stem Cell and Regulatory T Cells in Treating End-stage Liver Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03460795
Recruitment Status : Not yet recruiting
First Posted : March 9, 2018
Last Update Posted : March 4, 2020
Sponsor:
Information provided by (Responsible Party):
Ling Lu, Nanjing Medical University

Tracking Information
First Submitted Date  ICMJE February 23, 2018
First Posted Date  ICMJE March 9, 2018
Last Update Posted Date March 4, 2020
Estimated Study Start Date  ICMJE June 1, 2020
Estimated Primary Completion Date March 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2018)
  • Albumin (ALB) [ Time Frame: 24 months ]
    The evaluation of serum levels of ALB
  • Alanine aminotransferase (ALT) [ Time Frame: 24 months ]
    The evaluation of serum levels of ALT
  • Prealbumin (PA) [ Time Frame: 24 months ]
    The evaluation of serum levels of PA
  • Total bilirubin (TB) [ Time Frame: 24 months ]
    The evaluation of serum levels of TB
  • Direct bilirubin (DB) [ Time Frame: 24 months ]
    The evaluation of serum levels of DB
  • Blood urea nitrogen (BUN) [ Time Frame: 24 months ]
    The evaluation of serum levels of BUN
  • Uric acid (UA) [ Time Frame: 24 months ]
    The evaluation of serum levels of UA
  • Serum creatinine (Scr) [ Time Frame: 24 months ]
    The evaluation of serum levels of Scr
Original Primary Outcome Measures  ICMJE
 (submitted: March 8, 2018)
  • ALB [ Time Frame: 24 months ]
    The evaluation of serum levels of ALB
  • ALT [ Time Frame: 24 months ]
    The evaluation of serum levels of ALT
  • PA [ Time Frame: 24 months ]
    The evaluation of serum levels of PA
  • TB [ Time Frame: 24 months ]
    The evaluation of serum levels of TB
  • DB [ Time Frame: 24 months ]
    The evaluation of serum levels of DB
  • BUN [ Time Frame: 24 months ]
    The evaluation of serum levels of BUN
  • UA [ Time Frame: 24 months ]
    The evaluation of serum levels of UA
  • Cr [ Time Frame: 24 months ]
    The evaluation of serum levels of Cr
  • INR [ Time Frame: 24 months ]
    The evaluation of serum levels of INR
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2018)
  • Child-Pugh [ Time Frame: 24 months ]
    The evaluation of Child-Pugh score for liver function
  • Model for end-stage liver disease (MELD) [ Time Frame: 24 months ]
    The evaluation of MELD score for severity of liver disease
  • Quality of life (QOL) [ Time Frame: 24 months ]
    The evaluation of QOL score for life quality
Original Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2018)
  • Child-Pugh [ Time Frame: 24 months ]
    The evaluation of Child-Pugh score for liver function
  • MELD [ Time Frame: 24 months ]
    The evaluation of MELD score for severity of liver disease
  • QOL [ Time Frame: 24 months ]
    The evaluation of QOL score for life quality
Current Other Pre-specified Outcome Measures
 (submitted: March 8, 2018)
Evaluation of liver fibrosis [ Time Frame: 24 months ]
The pathology decrease in grade of liver fibrosis
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Co-transfering of Mesenchymal Stem Cell and Regulatory T Cells in Treating End-stage Liver Disease
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Liver Cirrhosis
Intervention  ICMJE Biological: MSC and Tregs
conventional plus MSC and Tregs or placebo treatment
Study Arms  ICMJE Experimental: Conventional plus MSC and Tregs treatment
Intervention: Biological: MSC and Tregs
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 8, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2025
Estimated Primary Completion Date March 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Clinically diagnosed as decompensated liver cirrhosis.
  2. 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.
  3. 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.
  4. Need to intermittently supplement albumin and apply diuretic therapy.
  5. 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).
  6. 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.
  7. Unconditional acceptance of orthotopic liver transplantation.
  8. Aged from 18 to 65 years.
  9. Voluntarily signed informed consent form.

Exclusion Criteria:

  1. A malignant tumor with liver or other organs or a history of previous cancer.
  2. Complications include gastrointestinal bleeding, spontaneous peritonitis, hepatic encephalopathy, hepatorenal syndrome, and Acute infection episodes.
  3. Patients with severe heart, lung, kidney or blood system diseases and failure status.
  4. Pregnant or lactating women.
  5. Allergic constitution.
  6. There is a history of alcohol abuse, drug abuse, and failure to effectively quit.
  7. Patients did not participate in other clinical trials within 4 weeks.
  8. Any condition, investigator believe that patients should not participate in this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Ling Lu, M.D, PH.D 86-025-68136053 lvling@njmu.edu.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03460795
Other Study ID Numbers  ICMJE NJLT005
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ling Lu, Nanjing Medical University
Study Sponsor  ICMJE Nanjing Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jinhai Tang, M.D, PH.D Nanjing Medical University
PRS Account Nanjing Medical University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP