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

Other Surgical Procedures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01491165
• Other study ID #: 2011-12-07 liver cirrhosis
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: December 8, 2011
• Last updated: October 25, 2012
• Start date: December 2011
• Est. completion date: June 2014

Study information

• Verified date: October 2012
• Source: General Hospital of Chinese Armed Police Forces
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: June 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Cirrhosis
• Other Surgical Procedures

Intervention

Procedure:
• stem cell transplantation through interventional procedures
one time interventional procedures

Locations

Country	Name	City	State
China	Yihua An	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
General Hospital of Chinese Armed Police Forces	Taian Hospital of Traditional Chinese Medicine, Xinjiang Armed Police Corps Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	liver biopsy	The result of liver biopsy judged by the expert.	whinin 7 days before transplantation, 6 and 12 months after transplantation	Yes
Secondary	gastroscopy	Observe and photograph the related varicose veins.	whinin 7 days before transplantation, 6 and 12 months after transplantation	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	liver enzyme fiber spectrum	laminin (LN); ? collagen detection (CIV); hyaluronic acid (HA); procollagen ?(PC ?)	whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation	Yes
Secondary	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	Yes
Secondary	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	Yes