Mobilization of Mesenchymal Stem Cells During Liver Transplantation
1 other identifier
observational
35
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 18, 2015
CompletedFirst Posted
Study publicly available on registry
September 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedOctober 16, 2018
October 1, 2018
1.8 years
September 18, 2015
October 15, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
post operative liver injury
. Primary endpoint is defined by postoperative liver injury assessed by peak serum value of aspartate aminotransferase (AST) or alanine aminotransferase (ALT).
0-7 post operative days
Secondary Outcomes (4)
Total Bilirubin level
post operative day 7
(INR) International Normalized Ratio
post operative day 7
(ALT) Alanine Aminotransferase
post operative day 7
(AST) Aspartate Aminotransferase
post operative day 7
Study Arms (2)
liver transplant patients
5 blood samples at time points as described in protocol
Liver resection patients
3 blood samples at time points described in protocol
Interventions
liver transplant patients will have (5) 3cc blood samples drawn at specific time points.
Eligibility Criteria
Patients undergoing liver transplant or liver resection
You may qualify if:
- Patients 21-80 capable of providing informed consent
- ASA rating between 1-4
- Patients undergoing liver transplant or liver surgery for the first time.
You may not qualify if:
- Patient less than 21 years of age
- Patients unwilling to consent
- If donor liver was obtained after cardiac death
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital
Newark, New Jersey, 07103, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yuriy Gubenko, MD
Rutrgers/SUNJ
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Department of Anesthesiology, Rutgers - NJMS
Study Record Dates
First Submitted
September 18, 2015
First Posted
September 23, 2015
Study Start
September 1, 2015
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
October 16, 2018
Record last verified: 2018-10