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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

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.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Biological: MSC and Tregs Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : March 1, 2025
Estimated Study Completion Date : September 1, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Conventional plus MSC and Tregs treatment Biological: MSC and Tregs
conventional plus MSC and Tregs or placebo treatment




Primary Outcome Measures :
  1. Albumin (ALB) [ Time Frame: 24 months ]
    The evaluation of serum levels of ALB

  2. Alanine aminotransferase (ALT) [ Time Frame: 24 months ]
    The evaluation of serum levels of ALT

  3. Prealbumin (PA) [ Time Frame: 24 months ]
    The evaluation of serum levels of PA

  4. Total bilirubin (TB) [ Time Frame: 24 months ]
    The evaluation of serum levels of TB

  5. Direct bilirubin (DB) [ Time Frame: 24 months ]
    The evaluation of serum levels of DB

  6. Blood urea nitrogen (BUN) [ Time Frame: 24 months ]
    The evaluation of serum levels of BUN

  7. Uric acid (UA) [ Time Frame: 24 months ]
    The evaluation of serum levels of UA

  8. Serum creatinine (Scr) [ Time Frame: 24 months ]
    The evaluation of serum levels of Scr


Secondary Outcome Measures :
  1. Child-Pugh [ Time Frame: 24 months ]
    The evaluation of Child-Pugh score for liver function

  2. Model for end-stage liver disease (MELD) [ Time Frame: 24 months ]
    The evaluation of MELD score for severity of liver disease

  3. Quality of life (QOL) [ Time Frame: 24 months ]
    The evaluation of QOL score for life quality


Other Outcome Measures:
  1. Evaluation of liver fibrosis [ Time Frame: 24 months ]
    The pathology decrease in grade of liver fibrosis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03460795


Contacts
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Contact: Ling Lu, M.D, PH.D 86-025-68136053 lvling@njmu.edu.cn

Locations
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China, Jiangsu
Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Contact: Ling Lu, M.D, PH. D.    86-025-68136053    lvling@njmu.edu.cn   
Sponsors and Collaborators
Nanjing Medical University
Investigators
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Study Chair: Jinhai Tang, M.D, PH.D Nanjing Medical University
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Responsible Party: Ling Lu, Principal Investigator, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03460795    
Other Study ID Numbers: NJLT005
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Liver Cirrhosis
End Stage Liver Disease
Digestive System Diseases
Liver Failure
Hepatic Insufficiency