Mesenchymal Stem Cells Transplantation for Ischemic-type Biliary Lesions

NCT02223897 | Unknown Phase 2 DMC

• 1 other identifier: 2014006
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Liver transplantation; Biliary complication; mesenchymal stem cells

Outcome Measures

Primary Outcomes (1)

• The incidence of ITBLs

  18 months

Secondary Outcomes (2)

• Changes in biliary enzymology

  18 months

• Biliary blood supply

  18 months

Other Outcomes (1)

• life quality

  18 months

Study Arms (2)

Conventional treatment, huc-MSCs

EXPERIMENTAL

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: huc-MSCs

Conventional plus placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

huc-MSCs DRUG

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.

Also known as: Umbilical Cord-Derived Mesenchymal Stem Cells

Conventional treatment, huc-MSCs

Placebo DRUG

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).

Also known as: saline solution

Conventional plus placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• benign end-stage liver disease patients with liver transplantation.
• ages of 18 and 60 years.
• first liver transplant.
• gamma-glutamyltransferase \> 300 U/L for 2 weeks, and there was no or low enhancement of the wall of the hilar bile duct in arterial phase via contrast-enhanced ultrasonography.
• Written informed consent.

You may not qualify if:

• second or combined organ transplant recipient.
• vital organs failure (Cardiac, Renal or Respiratory, et al).
• clinically active bacterial, fungal, viral or parasitic infection.
• other candidates who are judged to be not applicable to this study by investigators.

Sponsors & Collaborators

• Yang Yang: lead

Study Sites (1)

Third Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510630, China

RECRUITING

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Yang Yang, MD

  Third Affiliated Hospital, Sun Yat-Sen University

  STUDY CHAIR

Central Study Contacts

Yang yang, MD

CONTACT

yysysu@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department of Transplantation

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: August 22, 2014
• Study Start: July 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2018
• Last Updated: August 22, 2014

Record last verified: 2014-08

Locations

CN (1)