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Human Umbilical Cord-Mesenchymal Stem Cells for Hepatic Cirrhosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 7, 2016
First Posted Date  ICMJE January 11, 2016
Last Update Posted Date May 23, 2016
Study Start Date  ICMJE March 2016
Estimated Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2016)
Severity of adverse events [ Time Frame: 12 months ]
According to National Cancer Institute Common Terminology Criteria for Adverse Events(NCI-CTCAE)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2016)
  • Hepatic function [ Time Frame: 1, 3 ,6 and 12 months ]
    Include AST, ALT, T-Bil and A/G.
  • Liver fibrosis index [ Time Frame: 1, 3 ,6 and 12 months ]
    The level of Hyaluronidase,Laminin,Procollagen Ⅲ and Collagen Type IV in serum.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Human Umbilical Cord-Mesenchymal Stem Cells for Hepatic Cirrhosis
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatic Cirrhosis
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: hUC-MSC treatment
Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up.
Intervention: Biological: Human umbilical cord mesenchymal stem cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 7, 2016)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2016
Estimated Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02652351
Other Study ID Numbers  ICMJE HYK-hepatic cirrhosis
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Shenzhen Hornetcorn Bio-technology Company, LTD
Study Sponsor  ICMJE Shenzhen Hornetcorn Bio-technology Company, LTD
Collaborators  ICMJE The Second Affiliated Hospital of University of South China
Investigators  ICMJE
Principal Investigator: Gang Chen, Professor The second Affiliated Hospital of University of Soth China
PRS Account Shenzhen Hornetcorn Bio-technology Company, LTD
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP