Clinical trial NCT01718587: Difference in Efficacy Between Stem Cell Transplantation and Classical Therapy in Liver Cirrhosis Patients
Official title: Difference in Efficacy Between Umbilical Cord Mesenchyma Stem Cell Transplantation and Classical Therapy in Liver Cirrhosis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Liver Cirrhosis
Keywords: umbilical cord mesenchyma stem cell
liver cirrhosis
antiviral therapy
Lead sponsor: General Hospital of Chinese Armed Police Forces
Sponsor class: OTHER
Collaborators: name: The First Hospital of Hebei Medical University
First posted: 2012-10-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: liver volume calculated by MRI
timeFrame: baseline
measure: change from baseline in liver volume calculated by MRI at 6 months
timeFrame: 6 months after treatment
measure: change from baseline in liver volume calculated by MRI at 12 months
timeFrame: 12 months after treatment
Secondary outcomes:
measure: blood biochemistry
timeFrame: baseline, 1,3,6 and 12 months after treatment or transplantation
measure: blood test
timeFrame: baseline,1,3,6 and 12 months after treatment or transplantation
measure: liver enzyme fiber spectrum
timeFrame: baseline,1,3,6 and 12 months after treatment or transplantation
measure: coagulation
timeFrame: baselin,1,3,6 and 12 months after treatment or transplantation
measure: portal vein and splenic vein measure
timeFrame: baseline,1,3,6 and 12 months after treatment or transplantation
measure: estrogen and progestin in blood
timeFrame: baseline,1,3,6 and 12 months after treatment or transplantation
Other outcomes:
measure: liver biopsy
timeFrame: baseline,6 and 12 months after transplantation
measure: gastroscopy
timeFrame: baseline,6 and 12 months after treatment or transplantation
Locations:
city: Beijing
country: China
facility: Yihua An
Study officials:
affiliation: Department of Stem Cell Transplantation, the General Hospital of Chinese People's Armed Police Force
name: Yihua An, PhD
role: STUDY_DIRECTOR
References: