Difference in Efficacy Between Stem Cell Transplantation and Classical Therapy in Liver Cirrhosis Patients

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2012 by General Hospital of Chinese Armed Police Forces
Sponsor:
Collaborator:
Hebei Medical University First Hospital
Information provided by (Responsible Party):
General Hospital of Chinese Armed Police Forces
ClinicalTrials.gov Identifier:
NCT01718587
First received: October 25, 2012
Last updated: October 30, 2012
Last verified: October 2012
  Purpose

The current treatment methods of liver cirrhosis are limited ,including antiviral therapy,supportive therapy and liver transplantation. Antiviral therapy and Supportive therapy especially the regularly intravenous infusions of plasma or albumin are combined in the clinical classical therapy treatment. In the other hand,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 and classical therapy in patients liver cirrhosis will be evaluated and compared.


Condition Intervention Phase
Liver Cirrhosis
Procedure: stem cell transplantation through interventional procedure
Drug: antiviral therapy (lamivudine, other antiviral drugs)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Difference in Efficacy Between Umbilical Cord Mesenchyma Stem Cell Transplantation and Classical Therapy 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: baseline ] [ Designated as safety issue: Yes ]
    Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.

  • change from baseline in liver volume calculated by MRI at 6 months [ Time Frame: 6 months after treatment ] [ Designated as safety issue: Yes ]
    Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.

  • change from baseline in liver volume calculated by MRI at 12 months [ Time Frame: 12 months after treatment ] [ Designated as safety issue: Yes ]
    Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.


Secondary Outcome Measures:
  • blood biochemistry [ Time Frame: baseline, 1,3,6 and 12 months after treatment or 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. albumin
    9. the proportion of white balls

  • blood test [ Time Frame: baseline,1,3,6 and 12 months after treatment or 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: baseline,1,3,6 and 12 months after treatment or 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: baselin,1,3,6 and 12 months after treatment or 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: baseline,1,3,6 and 12 months after treatment or 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)

  • estrogen and progestin in blood [ Time Frame: baseline,1,3,6 and 12 months after treatment or transplantation ] [ Designated as safety issue: Yes ]
    estrogen and progestin


Other Outcome Measures:
  • liver biopsy [ Time Frame: baseline,6 and 12 months after transplantation ] [ Designated as safety issue: Yes ]
    The result of liver biopsy judged by the same one expert.

  • gastroscopy [ Time Frame: baseline,6 and 12 months after treatment or transplantation ] [ Designated as safety issue: Yes ]
    Observe and photograph the related varicose veins.


Estimated Enrollment: 60
Study Start Date: November 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: May 2013 (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 procedure
interventional procedure once
Other Name: UCMSC transplantation
Active Comparator: antiviral therapy

Antiviral therapy: lamivudine, 100 mg per day (oral dose); or adefovir dipivoxil 10 mg per day (oral dose); or grace entecavir 0.5-1mg per day (oral dose); or behalftelbivudine 600 mg per day (oral dose).

Supportive therapy are allowed to use on patients not including intravenous infusions of plasma or albumin.

Drug: antiviral therapy (lamivudine, other antiviral drugs)
lamivudine, 100 mg per day (oral dose); or adefovir dipivoxil 10 mg per day (oral dose); or grace entecavir 0.5-1mg per day (oral dose); or behalftelbivudine 600 mg per day (oral dose).
Other Name: lamivudine or other antiviral drugs.

Detailed Description:

This study will includ two research centers, the number of patients in transplantation group will be 30, the number of patients in classical therapy group will be 30. All the inclusion and exclusion criteria will be same and the data 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: NCT01718587

Contacts
Contact: Yihua An, PhD 0086-10-57976845 doctoran2010@hotmail.com

Locations
China
Yihua An
Beijing, China
Sponsors and Collaborators
General Hospital of Chinese Armed Police Forces
Hebei Medical University First Hospital
Investigators
Study Director: Yihua An, PhD 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: NCT01718587     History of Changes
Other Study ID Numbers: 2012-10-09 TC liver cirrhosis
Study First Received: October 25, 2012
Last Updated: October 30, 2012
Health Authority: China: Ministry of Health of Logistics Department in the Chinese People's Armed Police Force

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

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes
Antiviral Agents
Adefovir dipivoxil
Lamivudine
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on July 20, 2014