Umbilical Cord Blood Mononuclear Cells Therapy in Liver Cirrhosis

NCT01942915 | Unknown Phase 1 DMC

• 1 other identifier: 12276102D-Liver Cirrhosis
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• child-pugh classification

  1. child-pugh A (child-pugh score 5-6) 2. child-pugh B (child-pugh score 7-9) 3. child-pugh C (child-pugh score≥10)

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

Secondary Outcomes (5)

• coagulation

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

• liver function

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

• vital signs

  1, 2 and 3 days after transplantation

• incidence of hepatocellular carcinoma

  1, 3 and 6 months after transplantation

• mortality

  1, 3 and 6 months after transplantation

Study Arms (1)

umbilical cord blood mononuclear cells

EXPERIMENTAL

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.

Biological: Umbilical Cord Blood Mononuclear Cells

Interventions

Umbilical Cord Blood Mononuclear Cells BIOLOGICAL

Participants will be transplanted with umbilical cord blood mononuclear cells.

umbilical cord blood mononuclear cells

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with C class by child-pugh score
• Patients in the acute phase of severe hepatitis
• Patients have been diagnosed with cancer of the liver
• Patients with severe cardiopulmonary cerebral disease, and in the failure state
• Patients in Highly allergic constitution
• Patients with moderately severe mental disease

Sponsors & Collaborators

• Hebei Medical University: lead

Study Sites (1)

the First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Baoyong Yan, doctor

  The First Hospital of Hebei Medical University

  STUDY CHAIR

• Lixin Tong, master

  The First Hospital of Hebei Medical University

  STUDY DIRECTOR

• Sui Zhang, master

  The First Hospital of Hebei Medical University

  PRINCIPAL INVESTIGATOR

• Quanhai Li, doctor

  The First Hospital of Hebei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cell Thearpy Center, the First Hospital of HeibeiMU

Study Record Dates

• First Submitted: September 6, 2013
• First Posted: September 16, 2013
• Study Start: January 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: November 15, 2013

Record last verified: 2013-11

Locations

CN (1)