NCT02652351

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 11, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

May 23, 2016

Status Verified

January 1, 2016

Enrollment Period

2 months

First QC Date

January 7, 2016

Last Update Submit

May 20, 2016

Conditions

Hepatic Cirrhosis

Keywords

Stem cellHuman Umbilical Cord Mesenchymal Stem CellMesenchymal Stem CellHepatic Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Severity of adverse events

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

    12 months

Secondary Outcomes (2)

  • Hepatic function

    1, 3 ,6 and 12 months

  • Liver fibrosis index

    1, 3 ,6 and 12 months

Study Arms (1)

hUC-MSC treatment

EXPERIMENTAL

Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up.

Biological: Human umbilical cord mesenchymal stem cells

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.

Also known as: hUC-MSC
hUC-MSC treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient who have signed the informed consent document;
  • Clinical, radiological, or biochemical evidence of liver cirrhosis.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The second Affiliated Hospital of University of Soth China

Hengyang, Hunan, 431224, China

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gang Chen, Professor

    The second Affiliated Hospital of University of Soth China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin S Cao, lab master

CONTACT

+86 0734-53137955CaoJS@hornetcon.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2016

First Posted

January 11, 2016

Study Start

March 1, 2016

Primary Completion

May 1, 2016

Study Completion

October 1, 2016

Last Updated

May 23, 2016

Record last verified: 2016-01

Locations

CN(1)