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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02223897 |
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Date of registration:
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21/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Mesenchymal Stem Cells Transplantation for Ischemic-type Biliary Lesions
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Scientific title:
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Umbilical Cord Mesenchymal Stem Cells Transplantation for Treatment of Patients With Ischemic-type Biliary Lesions After Liver Transplantation |
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Date of first enrolment:
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July 2014 |
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Target sample size:
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66 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02223897 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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China
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Contacts
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Name:
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Yang Yang, PHD |
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Address:
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Telephone:
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Email:
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yysysu@163.com |
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Affiliation:
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Name:
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Yang Yang, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Third Affiliated Hospital, Sun Yat-Sen University |
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Name:
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Yang yang, MD |
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Address:
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Telephone:
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Email:
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yysysu@163.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ischemic-type Biliary Lesions
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Intervention(s)
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Drug: Placebo
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Drug: huc-MSCs
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Primary Outcome(s)
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The incidence of ITBLs
[Time Frame: 18 months]
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Secondary Outcome(s)
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Changes in biliary enzymology
[Time Frame: 18 months]
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Biliary blood supply
[Time Frame: 18 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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