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Trial record 24 of 1236 for:    "North American Indian childhood cirrhosis" OR "Liver Cirrhosis"

Umbilical Cord Blood Mononuclear Cells Therapy in Liver Cirrhosis

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ClinicalTrials.gov Identifier: NCT01942915
Recruitment Status : Unknown
Verified November 2013 by Quanhai Li, Hebei Medical University.
Recruitment status was:  Active, not recruiting
First Posted : September 16, 2013
Last Update Posted : November 15, 2013
Sponsor:
Information provided by (Responsible Party):
Quanhai Li, Hebei Medical University

Brief Summary:
This study is to evaluate the safety and efficacy of umbilical cord blood mononuclear cells transplantation in liver cirrhosis patients.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Biological: Umbilical Cord Blood Mononuclear Cells Phase 1

Detailed Description:
Decompensated liver cirrhosis (LC), a life-threatening complication of chronic liver disease, is one of the major indications for liver transplantation. Recently, umbilical cord blood mononuclear cells transfusion has been shown to lead to the regression of liver fibrosis in animal model. The investigators thus investigated the safety of the therapy with life signs like temperature, pulse, blood pressure, the incidence of hepatocellular carcinoma and mortality and so on. And the efficacy was evaluated with the measurement of alanine aminotransferase (ALT), glutamic oxaloacetic transaminase (AST), total bilirubin (TBIL), direct bilirubin (DBIL), albumin (ALB), cholinesterase (CHE), prothrombin time (PT) and child-pugh score.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy Investigation of Patients With Liver Cirrhosis by Transplantation of Umbilical Cord Blood Mononuclear Cells
Study Start Date : January 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Arm Intervention/treatment
Experimental: umbilical cord blood mononuclear cells
Umbilical Cord blood come from healthy puerpera. Erythrocyte in umbilical cord blood was separated and deleted through sedimentation. Mononuclear cells in umbilical cord blood were then isolated with a conventional method and reagent,Ficoll,by density gradient centrifugation.
Biological: Umbilical Cord Blood Mononuclear Cells
Participants will be transplanted with umbilical cord blood mononuclear cells.




Primary Outcome Measures :
  1. child-pugh classification [ Time Frame: whinin 7 days before transplantation, 1,3 and 6 months after transplantation ]
    1. child-pugh A (child-pugh score 5-6)
    2. child-pugh B (child-pugh score 7-9)
    3. child-pugh C (child-pugh score≥10)


Secondary Outcome Measures :
  1. coagulation [ Time Frame: whinin 7 days before transplantation, 1,3,6 months after transplantation ]
    1. prothrombin time (PT)
    2. activated partial thromboplastin time (APTT)
    3. fibrinogen (FIB)

  2. liver function [ Time Frame: whinin 7 days before transplantation, 1,3 and 6 months after transplantation ]
    1. alanine aminotransferase (ALT)
    2. aspartate aminotransferase (AST)
    3. total bilirubin (TBIL)
    4. direct bilirubin (DBIL)
    5. serum cholinesterase (CHE)
    6. albumin (ALB)

  3. vital signs [ Time Frame: 1, 2 and 3 days after transplantation ]
    1. temperature
    2. pulse
    3. blood pressure

  4. incidence of hepatocellular carcinoma [ Time Frame: 1, 3 and 6 months after transplantation ]
  5. mortality [ Time Frame: 1, 3 and 6 months after transplantation ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with hepatocirrhosis: according to the standard of child- pugh, liver functions to achieve class A or B patients, Including C class patients but can achieve B class after treatment

Exclusion Criteria:

  1. Patients with C class by child-pugh score
  2. Patients in the acute phase of severe hepatitis
  3. Patients have been diagnosed with cancer of the liver
  4. Patients with severe cardiopulmonary cerebral disease, and in the failure state
  5. Patients in Highly allergic constitution
  6. Patients with moderately severe mental disease

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): NCT01942915


Locations
China, Hebei
the First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000
Sponsors and Collaborators
Hebei Medical University
Investigators
Study Chair: Baoyong Yan, doctor The First Hospital of Hebei Medical University
Study Director: Lixin Tong, master The First Hospital of Hebei Medical University
Principal Investigator: Sui Zhang, master The First Hospital of Hebei Medical University
Principal Investigator: Quanhai Li, doctor The First Hospital of Hebei Medical University

Responsible Party: Quanhai Li, Director of Cell Thearpy Center, the First Hospital of HeibeiMU, Hebei Medical University
ClinicalTrials.gov Identifier: NCT01942915     History of Changes
Other Study ID Numbers: 12276102D-Liver Cirrhosis
First Posted: September 16, 2013    Key Record Dates
Last Update Posted: November 15, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases