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Mobilization of Mesenchymal Stem Cells During Liver Transplantation

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ClinicalTrials.gov Identifier: NCT02557724
Recruitment Status : Completed
First Posted : September 23, 2015
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Yuriy Gubenko, MD, Rutgers, The State University of New Jersey

Brief Summary:
To study if the administration of corticoid hinder or enhance the mobilization of Mesenchymal Stem Cells (MSCs) in the peripheral blood during liver transplantation and whether this affects the outcome with respect to graft versus host response.

Condition or disease Intervention/treatment
Liver Failure Liver Neoplasm Procedure: blood samples

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Mobilization of Mesenchymal Stem Cells During Liver Transplantation
Study Start Date : September 2015
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
liver transplant patients
5 blood samples at time points as described in protocol
Procedure: blood samples
liver transplant patients will have (5) 3cc blood samples drawn at specific time points.

Liver resection patients
3 blood samples at time points described in protocol
Procedure: blood samples
liver resection patients will have (3) 3cc. blood samples drawn at specific time points




Primary Outcome Measures :
  1. post operative liver injury [ Time Frame: 0-7 post operative days ]
    . Primary endpoint is defined by postoperative liver injury assessed by peak serum value of aspartate aminotransferase (AST) or alanine aminotransferase (ALT).


Secondary Outcome Measures :
  1. Total Bilirubin level [ Time Frame: post operative day 7 ]
    bilirubin greater than or equal to 10mg/dl on day 7

  2. (INR) International Normalized Ratio [ Time Frame: post operative day 7 ]
    INR> or = to 1.6

  3. (ALT) Alanine Aminotransferase [ Time Frame: post operative day 7 ]
    ALT> 2000 IU/L

  4. (AST) Aspartate Aminotransferase [ Time Frame: post operative day 7 ]
    AST> 2000 IU/L



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing liver transplant or liver resection
Criteria

Inclusion Criteria:

  • • Patients 21-80 capable of providing informed consent

    • ASA rating between 1-4
    • Patients undergoing liver transplant or liver surgery for the first time.

Exclusion Criteria:

  • • Patient less than 21 years of age

    • Patients unwilling to consent
    • If donor liver was obtained after cardiac death

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557724


Locations
United States, New Jersey
University Hospital
Newark, New Jersey, United States, 07103
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
Principal Investigator: Yuriy Gubenko, MD Rutrgers/SUNJ

Responsible Party: Yuriy Gubenko, MD, Associate Professor, Department of Anesthesiology, Rutgers - NJMS, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT02557724     History of Changes
Other Study ID Numbers: 20140000266
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Liver Failure
Hepatic Insufficiency
Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Liver Extracts
Hematinics