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Mesenchymal Stem Cells Transplantation for Ischemic-type Biliary Lesions

NCT02223897 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2014-08-22

No results posted yet for this study

Summary

Ischemic-type biliary lesions (ITBLs) are a major cause of graft loss and mortality after orthotopic liver transplantation (OLT). For now, there are still lacking effective treatment for ITBLs. The purpose of this study is to confirm whether human umbilical cord mesenchymal stem cells are effective in the treatment,or prevention of Ischemic-type Biliary Lesions after liver transplantation.

Conditions

  • Ischemic-type Biliary Lesions

Interventions

DRUG

huc-MSCs

Received conventional treatment and huc-MSCs once per week for the first month and once per month for 6 months(9 times in total), at a dose of 1×106 huc-MSCs/kg body weight.

DRUG

Placebo

Received conventional treatment and 50 ml saline solution once per week for the first month and once per month for 6 months(9 times in total).

Sponsors & Collaborators

  • Yang Yang

    lead OTHER

Principal Investigators

  • Yang Yang, MD · Third Affiliated Hospital, Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2017-06-30
Completion
2018-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02223897 on ClinicalTrials.gov