Safety and Efficacy of Stem Cell Transplantation for Treatment of Liver Cirrhosis

Phase 2

• Conditions: Other Surgical Procedures
• Interventions: Procedure: stem cell transplantation through interventional procedures

• Registration Number: NCT01491165
• Lead Sponsor: General Hospital of Chinese Armed Police Forces

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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-08
• Study First Submitted QC: 2011-12-11
• Study First Posted: 2011-12-13
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-25
• Last Update Posted: 2012-10-26
• Primary Completion: 2012-12
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 75

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
stem cell transplantation therapy	stem cell transplantation through interventional procedures	umbilical cord mesenchyma stem cell transplantation through interventional procedures do in liver cirrhosis patients.

Primary Outcome Measures

Name	Time	Method
liver volume calculated by MRI	3 days before transplantation, 6 and 12 months after transplantation	Instrument:universal 1.5 Tesla superconducting MRI instrument. Slice thickness :2mm.

Secondary Outcome Measures

Name	Time	Method
liver enzyme fiber spectrum	whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation	1. laminin (LN); 2. Ⅳ collagen detection (CIV); 3. hyaluronic acid (HA); 4. procollagen Ⅲ(PC Ⅲ)
liver biopsy	whinin 7 days before transplantation, 6 and 12 months after transplantation	The result of liver biopsy judged by the expert.
portal vein and splenic vein measure	whinin 7 days before transplantation, 1,3,6 and 12 months after 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).
blood biochemistry	whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation	1. alanine aminotransferase; 2. aspartate aminotransferase; 3. gamma-glutamyltransferase(GGT); 4. alkaline phosphatase; 5. total bilirubin; 6. direct bilirubin; 7. The total bile acid (TBA); 8. serum cholinesterase (CHE); 9. total cholesterol (TC); 10. albumin; 11. the proportion of white balls
coagulation	whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation	1. prothrombin time (PT); 2. activated partial thromboplastin time (APTT); 3. fibrinogen (FIB); 4. thrombin time (TT)
blood test	whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation	1. platelet count (PLT); 2. mean platelet volume (MPV); 3. platelet distribution width (PDW); 4. platelet hematocrit (PCT); 5. alpha feto protein(AFP)
gastroscopy	whinin 7 days before transplantation, 6 and 12 months after transplantation	Observe and photograph the related varicose veins.

Trial Locations

Locations (1)

Yihua An; 🇨🇳 Beijing, China