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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01718587
• Other study ID #: 2012-10-09 TC liver cirrhosis
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: October 25, 2012
• Last updated: October 30, 2012
• Start date: November 2012
• Est. completion date: July 2014

Study information

• Verified date: October 2012
• Source: General Hospital of Chinese Armed Police Forces
• Contact: Yihua An, PhD
• Phone: 0086-10-57976845
• Email: doctoran2010[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health of Logistics Department in the Chinese People's Armed Police Force
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Cirrhosis

Intervention

Procedure:
• stem cell transplantation through interventional procedure
interventional procedure once

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).

Locations

Country	Name	City	State
China	Yihua An	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
General Hospital of Chinese Armed Police Forces	Hebei Medical University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	liver biopsy	The result of liver biopsy judged by the same one expert.	baseline,6 and 12 months after transplantation	Yes
Other	gastroscopy	Observe and photograph the related varicose veins.	baseline,6 and 12 months after treatment or transplantation	Yes
Primary	liver volume calculated by MRI	Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.	baseline	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	blood biochemistry	alanine aminotransferase; aspartate aminotransferase; gamma-glutamyltransferase(GGT); alkaline phosphatase; total bilirubin; direct bilirubin; The total bile acid (TBA); albumin; the proportion of white balls	baseline, 1,3,6 and 12 months after treatment or transplantation	Yes
Secondary	blood test	platelet count (PLT); mean platelet volume (MPV); platelet distribution width (PDW); platelet hematocrit (PCT); alpha feto protein (AFP)	baseline,1,3,6 and 12 months after treatment or transplantation	Yes
Secondary	liver enzyme fiber spectrum	laminin (LN); ? collagen detection (CIV); hyaluronic acid (HA); procollagen ?(PC ?)	baseline,1,3,6 and 12 months after treatment or transplantation	Yes
Secondary	coagulation	prothrombin time (PT); activated partial thromboplastin time (APTT); fibrinogen (FIB); thrombin time (TT)	baselin,1,3,6 and 12 months after treatment or transplantation	Yes
Secondary	portal vein and splenic vein measure	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)	baseline,1,3,6 and 12 months after treatment or transplantation	Yes
Secondary	estrogen and progestin in blood	estrogen and progestin	baseline,1,3,6 and 12 months after treatment or transplantation	Yes