Difference in Efficacy Between Stem Cell Transplantation and Classical Therapy in Liver Cirrhosis Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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.
Study Design
Arms and Interventions
| 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 procedure
interventional procedure once
Other Names:
|
| 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 Names:
|
Outcome Measures
Primary Outcome Measures
- liver volume calculated by MRI [baseline]
Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.
- change from baseline in liver volume calculated by MRI at 6 months [6 months after treatment]
Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.
- change from baseline in liver volume calculated by MRI at 12 months [12 months after treatment]
Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.
Secondary Outcome Measures
- blood biochemistry [baseline, 1,3,6 and 12 months after treatment or transplantation]
alanine aminotransferase aspartate aminotransferase gamma-glutamyltransferase(GGT) alkaline phosphatase total bilirubin direct bilirubin The total bile acid (TBA) albumin the proportion of white balls
- blood test [baseline,1,3,6 and 12 months after treatment or transplantation]
platelet count (PLT) mean platelet volume (MPV) platelet distribution width (PDW) platelet hematocrit (PCT) alpha feto protein (AFP)
- liver enzyme fiber spectrum [baseline,1,3,6 and 12 months after treatment or transplantation]
laminin (LN) Ⅳ collagen detection (CIV) hyaluronic acid (HA) procollagen Ⅲ(PC Ⅲ)
- coagulation [baselin,1,3,6 and 12 months after treatment or transplantation]
prothrombin time (PT) activated partial thromboplastin time (APTT) fibrinogen (FIB) thrombin time (TT)
- portal vein and splenic vein measure [baseline,1,3,6 and 12 months after treatment or 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)
- estrogen and progestin in blood [baseline,1,3,6 and 12 months after treatment or transplantation]
estrogen and progestin
Other Outcome Measures
- liver biopsy [baseline,6 and 12 months after transplantation]
The result of liver biopsy judged by the same one expert.
- gastroscopy [baseline,6 and 12 months after treatment or transplantation]
Observe and photograph the related varicose veins.
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Yihua An | Beijing | China |
Sponsors and Collaborators
- General Hospital of Chinese Armed Police Forces
- The First Hospital of Hebei Medical University
Investigators
- Study Director: Yihua An, PhD, Department of Stem Cell Transplantation, the General Hospital of Chinese People's Armed Police Force
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2012-10-09 TC liver cirrhosis