Human Umbilical Cord-Mesenchymal Stem Cells for Hepatic Cirrhosis

Shenzhen Hornetcorn Bio-technology Company, LTD20 enrolled

Overview

The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for Hepatic Cirrhosis.

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

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatic Cirrhosis

Interventions

Human umbilical cord mesenchymal stem cellsBIOLOGICAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

The second Affiliated Hospital of University of Soth China

Hengyang, Hunan, China

RECRUITING

Outcomes

Primary Outcomes

Severity of adverse events

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

Time frame: 12 months

Secondary Outcomes

Hepatic function

Include AST, ALT, T-Bil and A/G.

Time frame: 1, 3 ,6 and 12 months

Liver fibrosis index

The level of Hyaluronidase,Laminin,Procollagen Ⅲ and Collagen Type IV in serum.

Time frame: 1, 3 ,6 and 12 months

Central Contacts

Jin S Cao, lab master

CONTACT

+86 0734-53137955 CaoJS@hornetcon.com

Data from ClinicalTrials.gov

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