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Trial record 12 of 182 for:    uMBILICAL CORD MESENCHYMAL STEM CELLS

Human Umbilical Cord-Mesenchymal Stem Cells for Hepatic Cirrhosis

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ClinicalTrials.gov Identifier: NCT02652351
Recruitment Status : Unknown
Verified January 2016 by Shenzhen Hornetcorn Bio-technology Company, LTD.
Recruitment status was:  Recruiting
First Posted : January 11, 2016
Last Update Posted : May 23, 2016
Sponsor:
Collaborator:
The Second Affiliated Hospital of University of South China
Information provided by (Responsible Party):
Shenzhen Hornetcorn Bio-technology Company, LTD

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.

Condition or disease Intervention/treatment Phase
Hepatic Cirrhosis Biological: Human umbilical cord mesenchymal stem cells Phase 1

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  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy Study of Human Umbilical Cord-Mesenchymal Stem Cells for Hepatic Cirrhosis
Study Start Date : March 2016
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

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 Name: hUC-MSC




Primary Outcome Measures :
  1. Severity of adverse events [ Time Frame: 12 months ]
    According to National Cancer Institute Common Terminology Criteria for Adverse Events(NCI-CTCAE)


Secondary Outcome Measures :
  1. Hepatic function [ Time Frame: 1, 3 ,6 and 12 months ]
    Include AST, ALT, T-Bil and A/G.

  2. Liver fibrosis index [ Time Frame: 1, 3 ,6 and 12 months ]
    The level of Hyaluronidase,Laminin,Procollagen Ⅲ and Collagen Type IV in serum.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02652351


Contacts
Contact: Jin S Cao, lab master +86 0734-53137955 CaoJS@hornetcon.com

Locations
China, Hunan
The second Affiliated Hospital of University of Soth China Recruiting
Hengyang, Hunan, China, 431224
Contact: Gang Chen, Professor    0734-8899939 ext 621    Chengang@126.com   
Sponsors and Collaborators
Shenzhen Hornetcorn Bio-technology Company, LTD
The Second Affiliated Hospital of University of South China
Investigators
Principal Investigator: Gang Chen, Professor The second Affiliated Hospital of University of Soth China

Responsible Party: Shenzhen Hornetcorn Bio-technology Company, LTD
ClinicalTrials.gov Identifier: NCT02652351     History of Changes
Other Study ID Numbers: HYK-hepatic cirrhosis
First Posted: January 11, 2016    Key Record Dates
Last Update Posted: May 23, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Shenzhen Hornetcorn Bio-technology Company, LTD:
Stem cell
Human Umbilical Cord Mesenchymal Stem Cell
Mesenchymal Stem Cell
Hepatic Cirrhosis

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases