Clinical trial NCT01491165: Safety and Efficacy of Stem Cell Transplantation for Treatment of Liver Cirrhosis
Official title: Safety and Efficacy of Umbilical Cord Mesenchyma Stem Cell Transplantation in Liver Cirrhosis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Other Surgical Procedures
Keywords: umbilical cord mesenchyma stem cell
Lead sponsor: General Hospital of Chinese Armed Police Forces
Sponsor class: OTHER
Collaborators: name: Xinjiang Armed Police Corps Hospital
name: Taian Hospital of Traditional Chinese Medicine
First posted: 2011-12-13
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Mainstream of current treatment of liver cirrhosis is liver transplantation, but there are high cost, risk and immune rejection and other issues. 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 in patients liver cirrhosis will be evaluated.

Detailed description: This study included three research centers, each center were carried out 25 cases of liver cirrhosis in patients with stem cell transplantation. All the selection and exclusion criteria are same, data summary and 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: 3 days before transplantation, 6 and 12 months after transplantation
Secondary outcomes:
measure: liver biopsy
timeFrame: whinin 7 days before transplantation, 6 and 12 months after transplantation
measure: gastroscopy
timeFrame: whinin 7 days before transplantation, 6 and 12 months after transplantation
measure: blood biochemistry
timeFrame: whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation
measure: blood test
timeFrame: whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation
measure: liver enzyme fiber spectrum
timeFrame: whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation
measure: coagulation
timeFrame: whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation
measure: portal vein and splenic vein measure
timeFrame: whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation
Other outcomes:
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
role: STUDY_DIRECTOR
References: