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Clinical Trial of Umbilical Cord Mesenchymal Stem Cell Transfusion in Decompensated Liver Cirrhosis

NCT03529136 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2018-05-18

No results posted yet for this study

Summary

Decompensated liver cirrhosis is one of the life-threatening complication of chronic liver disease. Liver transplantation currently is the only effective method that can improve the survival of these patients. However, the severe shortage of donor livers, high cost, and potential serious complications have restricted the availability of liver transplantation.Umbilical cord mesenchymal stem cells (UC-MSC) has been generally shown to be safe and effective for liver diseases in some pre-clinical and clinical studies. This study aim to evaluate the safety and efficiency of human umbilical cord mesenchymal stem cell transfusion in patients with decompensated liver cirrhosis, and explore the best protocol of MSC transfusion.

Conditions

  • Decompensated Liver Cirrhosis

Interventions

BIOLOGICAL

UC-MSC

Human umbilical cord mesenchymal stem cells have driven from Wharton's jelly and cultured with serum-free medium in Shandong Cell and tissue bank. All of the cells in this study within three passages. Before transfusion, the mesenchymal stem cells were subjected to quality control. The UC-MSC were stained with anti-CD90-FITC, Anti-CD44-FITC, Anti-CD34-FITC and anti-45-FITC.

Sponsors & Collaborators

  • Shanghai Public Health Clinical Center

    collaborator OTHER_GOV

  • First Affiliated Hospital of Fujian Medical University

    collaborator OTHER

  • Yantai Hospital for Infectious Diseases

    collaborator UNKNOWN

  • The Second Affiliated Hospital of Chongqing Medical University

    collaborator OTHER

  • Jinan Hospital for Infectious Diseases

    collaborator UNKNOWN

  • Shandong Qilu Stem Cells Engineering Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jingbo Wang · Jinan Hospital for Infectious Diseases

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2019-12-31
Completion
2020-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03529136 on ClinicalTrials.gov