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Safety and Efficacy of Stem Cell Transplantation for Treatment of Liver Cirrhosis

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ClinicalTrials.gov Identifier: NCT01491165
Recruitment Status : Unknown
Verified October 2012 by General Hospital of Chinese Armed Police Forces.
Recruitment status was:  Recruiting
First Posted : December 13, 2011
Last Update Posted : October 26, 2012
Sponsor:
Collaborators:
Xinjiang Armed Police Corps Hospital
Taian Hospital of Traditional Chinese Medicine
Information provided by (Responsible Party):
General Hospital of Chinese Armed Police Forces

Study Description
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Brief Summary:
Mainstream of current treatment of liver cirrhosis is liver transplantation, but there are high cost, risk and immune rejection and other issues. Umbilical cord mesenchyma stem cell with self-and directed differentiation capacity can effectively rescue experimental liver failure and contribute to liver regeneration, which suggests the feasibility of stem cell transplantation therapy. In this study, the safety and efficacy of umbilical cord mesenchyma stem cell transplantation through interventional procedures in patients liver cirrhosis will be evaluated.

Condition or disease Intervention/treatment Phase
Other Surgical Procedures Procedure: stem cell transplantation through interventional procedures Phase 2 Phase 3

Detailed Description:
This study included three research centers, each center were carried out 25 cases of liver cirrhosis in patients with stem cell transplantation. All the selection and exclusion criteria are same, data summary and analysis will be complete by the epidemiological commissioner.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Umbilical Cord Mesenchyma Stem Cell Transplantation in Liver Cirrhosis Patients
Study Start Date : December 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: stem cell transplantation therapy
umbilical cord mesenchyma stem cell transplantation through interventional procedures do in liver cirrhosis patients.
 Procedure: stem cell transplantation through interventional procedures
one time interventional procedures
Other Name: umbilical cord mesenchyma stem cell transplantation


Outcome Measures
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Primary Outcome Measures :
  1. liver volume calculated by MRI [ Time Frame: 3 days before transplantation, 6 and 12 months after transplantation ]
    Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.


Secondary Outcome Measures :
  1. liver biopsy [ Time Frame: whinin 7 days before transplantation, 6 and 12 months after transplantation ]
    The result of liver biopsy judged by the expert.

  2. gastroscopy [ Time Frame: whinin 7 days before transplantation, 6 and 12 months after transplantation ]
    Observe and photograph the related varicose veins.

  3. blood biochemistry [ Time Frame: whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation ]
    1. alanine aminotransferase
    2. aspartate aminotransferase
    3. gamma-glutamyltransferase(GGT)
    4. alkaline phosphatase
    5. total bilirubin
    6. direct bilirubin
    7. The total bile acid (TBA)
    8. serum cholinesterase (CHE)
    9. total cholesterol (TC)
    10. albumin
    11. the proportion of white balls

  4. blood test [ Time Frame: whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation ]
    1. platelet count (PLT)
    2. mean platelet volume (MPV)
    3. platelet distribution width (PDW)
    4. platelet hematocrit (PCT)
    5. alpha feto protein(AFP)

  5. liver enzyme fiber spectrum [ Time Frame: whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation ]
    1. laminin (LN)
    2. Ⅳ collagen detection (CIV)
    3. hyaluronic acid (HA)
    4. procollagen Ⅲ(PC Ⅲ)

  6. coagulation [ Time Frame: whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation ]
    1. prothrombin time (PT)
    2. activated partial thromboplastin time (APTT)
    3. fibrinogen (FIB)
    4. thrombin time (TT)

  7. portal vein and splenic vein measure [ Time Frame: whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation ]
    1. Portal vein diameter (Dpv);
    2. Portal vein maximum velocity (Vmaxpv);
    3. Portal vein blood flow per minute (Qpv);
    4. The splenic vein diameter (Dsv);
    5. Splenic vein maximum flow velocity (Vmaxsv);
    6. Splenic vein blood flow per minute (Qsv).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of liver cirrhosis;
  • Without hepatic encephalopathy;
  • No ascites or have easily dissipated ascites;
  • Value of bilirubin is less than 100;
  • Value of albumin is greater than 16 g / L;
  • Prothrombin time is less than 21 seconds;

Exclusion Criteria:

  • Severe cardiovascular disease, and immunocompromised patients;
  • Patients with localized lesions affecting graft infection;
  • Coagulation disorders;
  • Liver nodules more than 2cm or Liver cancer
Contacts and Locations
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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): NCT01491165


Locations
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China
Yihua An Recruiting
Beijing, China
Contact: Yihua An, doctor    0086-10-88276848    doctoran2010@hotmail.com   
Sponsors and Collaborators
General Hospital of Chinese Armed Police Forces
Xinjiang Armed Police Corps Hospital
Taian Hospital of Traditional Chinese Medicine
Investigators
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Study Director: Yihua An Department of Stem Cell Transplantation, the General Hospital of Chinese People's Armed Police Force
More Information
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Responsible Party: General Hospital of Chinese Armed Police Forces
ClinicalTrials.gov Identifier: NCT01491165    
Other Study ID Numbers: 2011-12-07 liver cirrhosis
First Posted: December 13, 2011    Key Record Dates
Last Update Posted: October 26, 2012
Last Verified: October 2012
Keywords provided by General Hospital of Chinese Armed Police Forces:
umbilical cord mesenchyma stem cell
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases