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

NCT01718587 | Unknown Phase 1 DMC

• 1 other identifier: 2012-10-09 TC liver cirrhosis
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Liver Cirrhosis

Keywords

umbilical cord mesenchyma stem cell; liver cirrhosis; antiviral therapy

Outcome Measures

Primary Outcomes (3)

• liver volume calculated by MRI

  Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.

  baseline

• change from baseline in liver volume calculated by MRI at 6 months

  Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.

  6 months after treatment

• change from baseline in liver volume calculated by MRI at 12 months

  Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.

  12 months after treatment

Secondary Outcomes (6)

• blood biochemistry

  baseline, 1,3,6 and 12 months after treatment or transplantation

• blood test

  baseline,1,3,6 and 12 months after treatment or transplantation

• liver enzyme fiber spectrum

  baseline,1,3,6 and 12 months after treatment or transplantation

• coagulation

  baselin,1,3,6 and 12 months after treatment or transplantation

• portal vein and splenic vein measure

  baseline,1,3,6 and 12 months after treatment or transplantation

Other Outcomes (2)

• liver biopsy

  baseline,6 and 12 months after transplantation

• gastroscopy

  baseline,6 and 12 months after treatment or transplantation

Study Arms (2)

stem cell transplantation therapy

EXPERIMENTAL

umbilical cord mesenchyma stem cell transplantation through interventional procedures do in liver cirrhosis patients.

Procedure: stem cell transplantation through interventional procedure

antiviral therapy

ACTIVE COMPARATOR

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)

Interventions

stem cell transplantation through interventional procedure PROCEDURE

interventional procedure once

Also known as: UCMSC transplantation

stem cell transplantation therapy

antiviral therapy (lamivudine, other antiviral drugs) DRUG

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).

Also known as: lamivudine or other antiviral drugs.

antiviral therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

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

Sponsors & Collaborators

• General Hospital of Chinese Armed Police Forces: lead
• The First Hospital of Hebei Medical University: collaborator

Study Sites (1)

Yihua An

Beijing, China

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Lamivudine

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Officials

• Yihua An, PhD

  Department of Stem Cell Transplantation, the General Hospital of Chinese People's Armed Police Force

  STUDY DIRECTOR

Central Study Contacts

Yihua An, PhD

CONTACT

0086-10-57976845; doctoran2010@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2012
• First Posted: October 31, 2012
• Study Start: November 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: July 1, 2014
• Last Updated: October 31, 2012

Record last verified: 2012-10

Locations

CN (1)