Clinical trial NCT01942915: Umbilical Cord Blood Mononuclear Cells Therapy in Liver Cirrhosis
Official title: Safety and Efficacy Investigation of Patients With Liver Cirrhosis by Transplantation of Umbilical Cord Blood Mononuclear Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Liver Cirrhosis
Lead sponsor: Hebei Medical University
Sponsor class: OTHER
First posted: 2013-09-16
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: child-pugh classification
timeFrame: whinin 7 days before transplantation, 1,3 and 6 months after transplantation
Secondary outcomes:
measure: coagulation
timeFrame: whinin 7 days before transplantation, 1,3,6 months after transplantation
measure: liver function
timeFrame: whinin 7 days before transplantation, 1,3 and 6 months after transplantation
measure: vital signs
timeFrame: 1, 2 and 3 days after transplantation
measure: incidence of hepatocellular carcinoma
timeFrame: 1, 3 and 6 months after transplantation
measure: mortality
timeFrame: 1, 3 and 6 months after transplantation
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: the First Hospital of Hebei Medical University
state: Hebei
Study officials:
affiliation: The First Hospital of Hebei Medical University
name: Baoyong Yan, doctor
role: STUDY_CHAIR
affiliation: The First Hospital of Hebei Medical University
name: Lixin Tong, master
role: STUDY_DIRECTOR
affiliation: The First Hospital of Hebei Medical University
name: Sui Zhang, master
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Hebei Medical University
name: Quanhai Li, doctor
role: PRINCIPAL_INVESTIGATOR
References: