Human Umbilical Cord-Mesenchymal Stem Cells for Hepatic Cirrhosis

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02652351

Enrollment

Registered

2016-01-11

Start date

2016-03-31

Completion date

2016-10-31

Last updated

2016-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Cirrhosis

Keywords

Stem cell, Human Umbilical Cord Mesenchymal Stem Cell, Mesenchymal Stem Cell, Hepatic Cirrhosis

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.

Interventions

BIOLOGICALHuman 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary ContactJin S Cao, lab master

CaoJS@hornetcon.com+86 0734-53137955

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026