Human Umbilical Cord-Mesenchymal Stem Cells for Hepatic Cirrhosis

Brief Title

Human Umbilical Cord-Mesenchymal Stem Cells for Hepatic Cirrhosis

Official Title

Safety and Efficacy Study of Human Umbilical Cord-Mesenchymal Stem Cells for Hepatic Cirrhosis

Brief Summary

      The purpose of this study is to evaluate the safety and efficacy of human umbilical cord
      mesenchymal stem cell(hUC-MSC) for Hepatic Cirrhosis.
    

Detailed Description

      Human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into
      mature cells typical of several tissues, which have been confirmed in in vivo and in vitro
      experiments. There have been few clinical reports describing umbilical cord mesenchymal stem
      cells for treatment of Hepatic Cirrhosis.

      To investigate the effects of hUC-MSC treatment for Hepatic Cirrhosis, 20 patients with
      Hepatic Cirrhosis will be enrolled and receive 4 times of hUC-MSC transplantation.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Severity of adverse events

Secondary Outcome

 Hepatic function

Condition

Hepatic Cirrhosis

Intervention

Human umbilical cord mesenchymal stem cells

Study Arms / Comparison Groups

 hUC-MSC treatment
Description:  Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

20

Start Date

March 2016

Completion Date

October 2016

Primary Completion Date

May 2016

Eligibility Criteria

        Inclusion Criteria:

          -  The patient who have signed the informed consent document;

          -  Clinical, radiological, or biochemical evidence of liver cirrhosis.

        Exclusion Criteria:

          -  Pregnant women or lactating mothers;

          -  Patients who have received any anti-inflammatory drugs including herb-drug within 14
             days;

          -  Patients who received any drug by intra-articular injection for treatment within 2
             months prior to this enrollment;

          -  Patients with positive human immunodeficiency (HIV) at screening indicative of current
             of pass infection;

          -  Abnormal blood coagulation, combine other tumor or special condition;

          -  Patients who had participated in other clinical trials within three months prior to
             this study.
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Gang Chen, Professor, +86 0734-53137955, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT02652351

Organization ID

HYK-hepatic cirrhosis


Responsible Party

Sponsor

Study Sponsor

Shenzhen Hornetcorn Bio-technology Company, LTD

Collaborators

 The Second Affiliated Hospital of University of South China

Study Sponsor

Gang Chen, Professor, Principal Investigator, The second Affiliated Hospital of University of Soth China


Verification Date

January 2016