NCT02706132

Brief Summary

The purpose of this study is to determine whether MSCs are safe and effective in reducing the primary nonfunction (PNF), acute rejection and Ischemic-type Biliary Lesions (ITBLs) morbidity in ABO-incompatible Liver Transplantation.

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
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2014

Typical duration 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

Study Start

First participant enrolled

February 1, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 11, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 11, 2016

Status Verified

March 1, 2016

Enrollment Period

2.8 years

First QC Date

March 8, 2016

Last Update Submit

March 8, 2016

Conditions

Liver Transplantation

Keywords

Mesenchymal stromal cellsLiver TransplantationABO blood group

Outcome Measures

Primary Outcomes (1)

  • Efficacy: one year graft survival rate

    one year

Secondary Outcomes (3)

  • the rate of acute rejection

    one year

  • the rate of ischemic-type biliary lesions

    one year

  • safety: rate of (serious) adverse events in the study population

    one year

Study Arms (1)

The MSCs group

EXPERIMENTAL

The group of patients receive allogeneic MSCs therapies.

Biological: Mesenchymal Stem Cells(MSCs)

Interventions

Mesenchymal Stem Cells(MSCs)BIOLOGICAL

Six doses of 1\*10\^6/kg body weight MSCs are given, intravenously.

The MSCs group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • First liver transplantation with a ABO-incompatible graft(B→A，AB→A，A→B，AB→B，A→O，B→O，AB→O).
  • Ages of 18 or older.
  • Patients receive liver transplantation due to benign end stage liver disease.
  • Patients or legal agent must be able to give informed consent.

You may not qualify if:

  • Second or combined organ transplant recipient.
  • Combined transplantations such as simultaneous liver/kidney transplants
  • Malignant disease.
  • Uncontrol bacterial, fungal, viral or parasitic infection.
  • Withdraw or unable to finish the follow-up.
  • Unwilling to sign informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Third Affiliated Hospital,Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

RECRUITING

Study Officials

  • Yang Yang

    Third Affiliated Hospital, Sun Yat-Sen University

    STUDY CHAIR

Central Study Contacts

Yang Yang

CONTACT

862085252276yysysu@163.com

Zhang Yingcai

CONTACT

86208525217776207884@qq.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Liver Transplantation

Study Record Dates

First Submitted

March 8, 2016

First Posted

March 11, 2016

Study Start

February 1, 2014

Primary Completion

December 1, 2016

Study Completion

March 1, 2017

Last Updated

March 11, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)