Umbilical Cord Blood Mononuclear Cells Therapy in Liver Cirrhosis

Liver Cirrhosis Clinical Trial

Official title:

Safety and Efficacy Investigation of Patients With Liver Cirrhosis by Transplantation of Umbilical Cord Blood Mononuclear Cells

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01942915
• Other study ID #: 12276102D-Liver Cirrhosis
• Status: Active, not recruiting
• Phase: Phase 1
• First received: September 6, 2013
• Last updated: November 14, 2013
• Start date: January 2012
• Est. completion date: December 2014

Study information

• Verified date: November 2013
• Source: Hebei Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is to evaluate the safety and efficacy of umbilical cord blood mononuclear cells transplantation in liver cirrhosis patients.

Description:

Decompensated liver cirrhosis (LC), a life-threatening complication of chronic liver disease, is one of the major indications for liver transplantation. Recently, umbilical cord blood mononuclear cells transfusion has been shown to lead to the regression of liver fibrosis in animal model. The investigators thus investigated the safety of the therapy with life signs like temperature, pulse, blood pressure, the incidence of hepatocellular carcinoma and mortality and so on. And the efficacy was evaluated with the measurement of alanine aminotransferase (ALT), glutamic oxaloacetic transaminase (AST), total bilirubin (TBIL), direct bilirubin (DBIL), albumin (ALB), cholinesterase (CHE), prothrombin time (PT) and child-pugh score.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with hepatocirrhosis: according to the standard of child- pugh, liver functions to achieve class A or B patients, Including C class patients but can achieve B class after treatment

Exclusion Criteria:

1. Patients with C class by child-pugh score

2. Patients in the acute phase of severe hepatitis

3. Patients have been diagnosed with cancer of the liver

4. Patients with severe cardiopulmonary cerebral disease, and in the failure state

5. Patients in Highly allergic constitution

6. Patients with moderately severe mental disease

Study Design

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

Related Conditions & MeSH terms

• Liver Cirrhosis

Intervention

Biological:
• Umbilical Cord Blood Mononuclear Cells
Participants will be transplanted with umbilical cord blood mononuclear cells.

Locations

Country	Name	City	State
China	the First Hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	child-pugh classification	child-pugh A (child-pugh score 5-6); child-pugh B (child-pugh score 7-9); child-pugh C (child-pugh score=10)	whinin 7 days before transplantation, 1,3 and 6 months after transplantation	No
Secondary	coagulation	prothrombin time (PT); activated partial thromboplastin time (APTT); fibrinogen (FIB)	whinin 7 days before transplantation, 1,3,6 months after transplantation	Yes
Secondary	liver function	alanine aminotransferase (ALT); aspartate aminotransferase (AST); total bilirubin (TBIL); direct bilirubin (DBIL); serum cholinesterase (CHE); albumin (ALB)	whinin 7 days before transplantation, 1,3 and 6 months after transplantation	Yes
Secondary	vital signs	temperature; pulse; blood pressure	1, 2 and 3 days after transplantation	Yes
Secondary	incidence of hepatocellular carcinoma		1, 3 and 6 months after transplantation	Yes
Secondary	mortality		1, 3 and 6 months after transplantation	Yes