Human Umbilical Cord-Mesenchymal Stem Cells for Hepatic Cirrhosis

Phase 1

• Conditions: Hepatic Cirrhosis
• Interventions: Biological: Human umbilical cord mesenchymal stem cells

• Registration Number: NCT02652351
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2016-01
• Study First Submitted: 2016-01-07
• Study First Submitted QC: 2016-01-07
• Study First Posted: 2016-01-11
• Study Start: 2016-03
• Primary Completion: 2016-05
• Last Update Submitted: 2016-05-20
• Last Update Posted: 2016-05-23
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
hUC-MSC treatment	Human umbilical cord mesenchymal stem cells	Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up.

Primary Outcome Measures

Name	Time	Method
Severity of adverse events	12 months	According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE)

Secondary Outcome Measures

Name	Time	Method
Hepatic function	1, 3 ,6 and 12 months	Include AST, ALT, T-Bil and A/G.
Liver fibrosis index	1, 3 ,6 and 12 months	The level of Hyaluronidase,Laminin,Procollagen Ⅲ and Collagen Type IV in serum.

Trial Locations

Locations (1)

The second Affiliated Hospital of University of Soth China; 🇨🇳 Hengyang, Hunan, China