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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by General Hospital of Chinese Armed Police Forces
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
ClinicalTrials.gov Identifier:
NCT01491165
First received: December 8, 2011
Last updated: October 25, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Other Surgical Procedures
Procedure: stem cell transplantation through interventional procedures
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Umbilical Cord Mesenchyma Stem Cell Transplantation in Liver Cirrhosis Patients

Resource links provided by NLM:


Further study details as provided by General Hospital of Chinese Armed Police Forces:

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


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

  • gastroscopy [ Time Frame: whinin 7 days before transplantation, 6 and 12 months after transplantation ] [ Designated as safety issue: Yes ]
    Observe and photograph the related varicose veins.

  • blood biochemistry [ Time Frame: whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation ] [ Designated as safety issue: Yes ]
    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

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

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

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

  • portal vein and splenic vein measure [ Time Frame: whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation ] [ Designated as safety issue: Yes ]
    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).


Estimated Enrollment: 75
Study Start Date: December 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01491165

Locations
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
Study Director: Yihua An Department of Stem Cell Transplantation, the General Hospital of Chinese People's Armed Police Force
  More Information

No publications provided

Responsible Party: General Hospital of Chinese Armed Police Forces
ClinicalTrials.gov Identifier: NCT01491165     History of Changes
Other Study ID Numbers: 2011-12-07 liver cirrhosis
Study First Received: December 8, 2011
Last Updated: October 25, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by General Hospital of Chinese Armed Police Forces:
umbilical cord mesenchyma stem cell

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

ClinicalTrials.gov processed this record on August 28, 2014