Human Umbilical Cord-Mesenchymal Stem Cells for Hepatic Cirrhosis

Hepatic Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02652351
• Other study ID #: HYK-hepatic cirrhosis
• 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

• Hepatic Cirrhosis
• Liver Cirrhosis

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