MedDataX Logo

Umbilical Cord Blood Mononuclear Cells Therapy in Liver Cirrhosis

NCT ID: NCT01942915

Last Updated: 2013-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Cirrhosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

umbilical cord blood mononuclear cells

Umbilical Cord blood come from healthy puerpera. Erythrocyte in umbilical cord blood was separated and deleted through sedimentation. Mononuclear cells in umbilical cord blood were then isolated with a conventional method and reagent,Ficoll,by density gradient centrifugation.

Group Type EXPERIMENTAL

Umbilical Cord Blood Mononuclear Cells

Intervention Type BIOLOGICAL

Participants will be transplanted with umbilical cord blood mononuclear cells.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Umbilical Cord Blood Mononuclear Cells

Participants will be transplanted with umbilical cord blood mononuclear cells.

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hebei Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Quanhai Li

Director of Cell Thearpy Center, the First Hospital of HeibeiMU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Baoyong Yan, doctor

Role: STUDY_CHAIR

The First Hospital of Hebei Medical University

Lixin Tong, master

Role: STUDY_DIRECTOR

The First Hospital of Hebei Medical University

Sui Zhang, master

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Hebei Medical University

Quanhai Li, doctor

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Hebei Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

the First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

12276102D-Liver Cirrhosis

Identifier Type: -

Identifier Source: org_study_id