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Safety and Efficacy Study of Mesenchymal Stem Cell in Treating Liver Fibrosis

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ClinicalTrials.gov Identifier: NCT03460795
Recruitment Status : Not yet recruiting
First Posted : March 9, 2018
Last Update Posted : March 16, 2018
Sponsor:
Information provided by (Responsible Party):
Ling Lu, Nanjing Medical University

Brief Summary:
Fibrosis of the liver is excessive accumulation of scar tissue that results from ongoing inflammation and liver cell death that occurs in most types of chronic liver diseases. 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. Fibrosis refers to the accumulation of tough, fibrous scar tissue in the liver. The potential for stem cells to differentiate into hepatocytes cells was recently confirmed. Particularly, mesenchymal stem cell (MSC) has been demonstrated to decrease model for end-stage liver disease (MELD) score and increase serum albumin in liver injury patients. Therefore, the investigators propose a hypothesis that MSCs can also improve the disease conditions of liver fibrosis patients, particularly reducing the decompensated conditions in these patients.

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

Detailed Description:
Fibrosis of the liver is excessive accumulation of scar tissue that results from ongoing inflammation and liver cell death that occurs in most types of chronic liver diseases. 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. Fibrosis refers to the accumulation of tough, fibrous scar tissue in the liver. 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 graft-vesus-host disease (GVHD), liver injury and displayed good tolerance and efficiency. The purpose of this study is to learn whether and how MSCs can improve the disease conditions in patients with liver cirrhosis. This study will also look at its safety in liver fibrosis patients.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Clinical Trial Using Mesenchymal Stem Cell as Individualized Medicine to Evaluate the Safety and Efficacy in Liver Fibrosis
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Conventional plus MSC treatment Biological: MSC
conventional plus MSC 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Written informed consent.
  2. 2 ≤ Liver fibrosis score ≤ 5.
  3. Child-Pugh B/C; MELD ≤ 21.
  4. Negative pregnancy test.
  5. Moderately active disease under standard treatment

Exclusion Criteria:

  1. Evidence of liver portal hypertension.
  2. Severe infection and cardiovascular disease, shock, secondary liver disease and malignant tumor.

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

Locations
China, Jiangsu
Nanjing Medical University Not yet recruiting
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
Study Chair: Jinhai Tang, M.D, PH.D Nanjing Medical University

Responsible Party: Ling Lu, Principal Investigator, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03460795     History of Changes
Other Study ID Numbers: NJLT005
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Liver Cirrhosis
Liver Diseases
Digestive System Diseases