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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02652351
Other study ID # HYK-hepatic cirrhosis
Secondary ID
Status Recruiting
Phase Phase 1
First received January 7, 2016
Last updated May 20, 2016
Start date March 2016
Est. completion date October 2016

Study information

Verified date January 2016
Source Shenzhen Hornetcorn Bio-technology Company, LTD
Contact Jin S Cao, lab master
Phone +86 0734-53137955
Email CaoJS@hornetcon.com
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date October 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
China The second Affiliated Hospital of University of Soth China Hengyang Hunan

Sponsors (2)

Lead Sponsor Collaborator
Shenzhen Hornetcorn Bio-technology Company, LTD The Second Affiliated Hospital of University of South China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Severity of adverse events According to National Cancer Institute Common Terminology Criteria for Adverse Events(NCI-CTCAE) 12 months Yes
Secondary Hepatic function Include AST, ALT, T-Bil and A/G. 1, 3 ,6 and 12 months No
Secondary Liver fibrosis index The level of Hyaluronidase,Laminin,Procollagen ? and Collagen Type IV in serum. 1, 3 ,6 and 12 months No
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