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

NCT01491165 | Unknown Phase 2 DMC

• 1 other identifier: 2011-12-07 liver cirrhosis
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Other Surgical Procedures

Keywords

umbilical cord mesenchyma stem cell

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• liver biopsy

  whinin 7 days before transplantation, 6 and 12 months after transplantation

• gastroscopy

  whinin 7 days before transplantation, 6 and 12 months after transplantation

• blood biochemistry

  whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation

• blood test

  whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation

• liver enzyme fiber spectrum

  whinin 7 days before transplantation, 1,3,6 and 12 months after transplantation

Study Arms (1)

stem cell transplantation therapy

EXPERIMENTAL

umbilical cord mesenchyma stem cell transplantation through interventional procedures do in liver cirrhosis patients.

Procedure: stem cell transplantation through interventional procedures

Interventions

stem cell transplantation through interventional procedures PROCEDURE

one time interventional procedures

Also known as: umbilical cord mesenchyma stem cell transplantation

stem cell transplantation therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• Severe cardiovascular disease, and immunocompromised patients;
• Patients with localized lesions affecting graft infection;
• Coagulation disorders;
• Liver nodules more than 2cm or Liver cancer

Sponsors & Collaborators

• General Hospital of Chinese Armed Police Forces: lead
• Xinjiang Armed Police Corps Hospital: collaborator
• Taian Hospital of Traditional Chinese Medicine: collaborator

Study Sites (1)

Yihua An

Beijing, China

RECRUITING

Study Officials

• Yihua An

  Department of Stem Cell Transplantation, the General Hospital of Chinese People's Armed Police Force

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2011
• First Posted: December 13, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2014
• Last Updated: October 26, 2012

Record last verified: 2012-10

Locations

CN (1)