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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

Tracking Information
First Submitted Date  ICMJE February 23, 2018
First Posted Date  ICMJE March 9, 2018
Last Update Posted Date March 16, 2018
Estimated Study Start Date  ICMJE April 1, 2018
Estimated Primary Completion Date March 1, 2020   (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 Complete list of historical versions of study NCT03460795 on ClinicalTrials.gov Archive Site
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 Mesenchymal Stem Cell in Treating Liver Fibrosis
Official Title  ICMJE Phase 1 Clinical Trial Using Mesenchymal Stem Cell as Individualized Medicine to Evaluate the Safety and Efficacy in Liver Fibrosis
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Liver Cirrhosis
Intervention  ICMJE Biological: MSC
conventional plus MSC or placebo treatment
Study Arms  ICMJE Experimental: Conventional plus MSC treatment
Intervention: Biological: MSC
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, 2020
Estimated Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 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 2018

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