Human Umbilical Cord-Mesenchymal Stem Cells for Hepatic Cirrhosis

May 20, 2016 updated by: Shenzhen Hornetcorn Bio-technology Company, LTD

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Hengyang, Hunan, China, 431224
        • Recruiting
        • The second Affiliated Hospital of University of Soth China
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hUC-MSC treatment
Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up.
Biological: Human umbilical cord mesenchymal stem cells
A single dose of 2×107 hUC-MSC will be implanted to patients by intravenous infusion or Hepatic artery intervention, and repeated every week for four times.
Other Names:
  • hUC-MSC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of adverse events
Time Frame: 12 months
According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hepatic function
Time Frame: 1, 3 ,6 and 12 months
Include AST, ALT, T-Bil and A/G.
1, 3 ,6 and 12 months
Liver fibrosis index
Time Frame: 1, 3 ,6 and 12 months
The level of Hyaluronidase,Laminin,Procollagen Ⅲ and Collagen Type IV in serum.
1, 3 ,6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen Hornetcorn Bio-technology Company, LTD

Collaborators

The Second Affiliated Hospital of University of South China

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

October 1, 2016

Study Registration Dates

First Submitted

January 7, 2016

First Submitted That Met QC Criteria

January 7, 2016

First Posted (Estimate)

January 11, 2016

Study Record Updates

Last Update Posted (Estimate)

May 23, 2016

Last Update Submitted That Met QC Criteria

May 20, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYK-hepatic cirrhosis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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