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

Safety and Efficacy of Umbilical Cord Mesenchyma Stem Cell Transplantation in Liver Cirrhosis Patients

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.

Study Overview

• Status: Unknown
• Conditions: Other Surgical Procedures
• Intervention / Treatment: Procedure: stem cell transplantation through interventional procedures

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 Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Yihua An

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 procedures; one time interventional procedures; Other Names: umbilical cord mesenchyma stem cell transplantation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
liver biopsy	The result of liver biopsy judged by the expert.	whinin 7 days before transplantation, 6 and 12 months after transplantation
gastroscopy	Observe and photograph the related varicose veins.	whinin 7 days before transplantation, 6 and 12 months after transplantation
blood biochemistry	alanine aminotransferase; aspartate aminotransferase; gamma-glutamyltransferase(GGT); alkaline phosphatase; total bilirubin; direct bilirubin; The total bile acid (TBA); serum cholinesterase (CHE); total cholesterol (TC); albumin; the proportion of white balls	whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation
blood test	platelet count (PLT); mean platelet volume (MPV); platelet distribution width (PDW); platelet hematocrit (PCT); alpha feto protein(AFP)	whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation
liver enzyme fiber spectrum	laminin (LN); Ⅳ collagen detection (CIV); hyaluronic acid (HA); procollagen Ⅲ(PC Ⅲ)	whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation
coagulation	prothrombin time (PT); activated partial thromboplastin time (APTT); fibrinogen (FIB); thrombin time (TT)	whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation
portal vein and splenic vein measure	Portal vein diameter (Dpv);; Portal vein maximum velocity (Vmaxpv);; Portal vein blood flow per minute (Qpv);; The splenic vein diameter (Dsv);; Splenic vein maximum flow velocity (Vmaxsv);; Splenic vein blood flow per minute (Qsv).	whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation

Collaborators and Investigators

• Sponsor: General Hospital of Chinese Armed Police Forces
• Collaborators: Xinjiang Armed Police Corps Hospital; Taian Hospital of Traditional Chinese Medicine
• Investigators: Study Director: Yihua An, Department of Stem Cell Transplantation, the General Hospital of Chinese People's Armed Police Force

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): June 1, 2014

Study Registration Dates

• First Submitted: December 8, 2011
• First Submitted That Met QC Criteria: December 11, 2011
• First Posted (Estimate): December 13, 2011

Study Record Updates

• Last Update Posted (Estimate): October 26, 2012
• Last Update Submitted That Met QC Criteria: October 25, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: umbilical cord mesenchyma stem cell
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: 2011-12-07 liver cirrhosis