search
Back to results

Human Umbilical Cord-Mesenchymal Stem Cells for Hepatic Cirrhosis

Primary Purpose

Hepatic Cirrhosis

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Human umbilical cord mesenchymal stem cells
Sponsored by
Shenzhen Hornetcorn Bio-technology Company, LTD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Cirrhosis focused on measuring Stem cell, Human Umbilical Cord Mesenchymal Stem Cell, Mesenchymal Stem Cell, Hepatic Cirrhosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The second Affiliated Hospital of University of Soth ChinaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

hUC-MSC treatment

Arm Description

Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up.

Outcomes

Primary Outcome Measures

Severity of adverse events
According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE)

Secondary Outcome Measures

Hepatic function
Include AST, ALT, T-Bil and A/G.
Liver fibrosis index
The level of Hyaluronidase,Laminin,Procollagen Ⅲ and Collagen Type IV in serum.

Full Information

First Posted
January 7, 2016
Last Updated
May 20, 2016
Sponsor
Shenzhen Hornetcorn Bio-technology Company, LTD
Collaborators
The Second Hospital University of South China
search

1. Study Identification

Unique Protocol Identification Number
NCT02652351
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Hornetcorn Bio-technology Company, LTD
Collaborators
The Second Hospital University of South China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Cirrhosis
Keywords
Stem cell, Human Umbilical Cord Mesenchymal Stem Cell, Mesenchymal Stem Cell, Hepatic Cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
hUC-MSC treatment
Arm Type
Experimental
Arm Description
Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up.
Intervention Type
Biological
Intervention Name(s)
Human umbilical cord mesenchymal stem cells
Other Intervention Name(s)
hUC-MSC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Severity of adverse events
Description
According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Hepatic function
Description
Include AST, ALT, T-Bil and A/G.
Time Frame
1, 3 ,6 and 12 months
Title
Liver fibrosis index
Description
The level of Hyaluronidase,Laminin,Procollagen Ⅲ and Collagen Type IV in serum.
Time Frame
1, 3 ,6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin S Cao, lab master
Phone
+86 0734-53137955
Email
CaoJS@hornetcon.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gang Chen, Professor
Organizational Affiliation
The second Affiliated Hospital of University of Soth China
Official's Role
Principal Investigator
Facility Information:
Facility Name
The second Affiliated Hospital of University of Soth China
City
Hengyang
State/Province
Hunan
ZIP/Postal Code
431224
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gang Chen, Professor
Phone
0734-8899939
Ext
621
Email
Chengang@126.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Human Umbilical Cord-Mesenchymal Stem Cells for Hepatic Cirrhosis

We'll reach out to this number within 24 hrs