Bone Marrow Derived Adult Liver Stem Cell Recruitment After Major Liver Resections: Correlation With Liver Regeneration and Hepatic Function
The results of this study may or may not establish useful baseline data, which will help us understand how bone marrow derived adult liver stem cells behave in normal healthy adults/volunteers (the control group), and in patients undergoing liver surgery. The bone marrow is located within your bones and is the organ which is responsible to produce blood cells and stem cells. Bone marrow derived adult liver stem cells are normal cells in your bone marrow. These liver stem cells have the capacity to regenerate or in other words to rebuild the liver after liver surgery, a process called liver regeneration. These cells are very important for the liver to regrow its tissue after liver surgery. These cells are thought to be activated in times of need by the liver.
Situations like liver surgery are one of these occasions when the liver will need the "extra help" from these stem cells.
The results of this study will establish the baseline data necessary for the understanding of how to harness the ability of these stem cells in times of liver surgery. Improvements in the ability of the liver to regrow after surgery is thought to decrease complications related to liver surgery. Harnessing this unique ability of stem cells may be utilized in the future to enhance the regrowing process of liver tissue after liver surgery, called liver regeneration.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults (≥ or equal to 18 years old).
- Patients scheduled for resection of 3 or more liver segments for any indication, with or without other planned procedures.
Or
- Normal healthy volunteers (control).
Exclusion Criteria:
- Chemotherapy or GCSF treatment in the preceding 4 weeks.
- CHILD'S classification B or above.
- Presence of active infection.
- History of lymphoma or leukemia.
- Normal healthy volunteers who underwent chemotherapy treatment at any stage of their life will be excluded.
- Normal healthy volunteers who are under any active treatment for any active illness will be excluded.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1
normal healthy volunteers
|
Baseline levels of bone marrow derived liver stem cells from normal healthy volunteers, which will be drawn once Two 5ml blue tubes).
At the time of preoperative testing, patients will have two extra test tubes (5cc blue top) of blood drawn for determination of pre-operative base line levels of bone marrow derived liver stem cells in peripheral blood.
Intraoperatively, blood will be drawn after liver resection (two tubes of 5cc blue top).
Two extra tube of blood will be drawn at the same time of routine postoperative blood drawing to determine levels of bone marrow derived liver stem cells in peripheral blood on post-operative days #1, and #3.
|
|
2
Patients undergoing major liver resections
|
Baseline levels of bone marrow derived liver stem cells from normal healthy volunteers, which will be drawn once Two 5ml blue tubes).
At the time of preoperative testing, patients will have two extra test tubes (5cc blue top) of blood drawn for determination of pre-operative base line levels of bone marrow derived liver stem cells in peripheral blood.
Intraoperatively, blood will be drawn after liver resection (two tubes of 5cc blue top).
Two extra tube of blood will be drawn at the same time of routine postoperative blood drawing to determine levels of bone marrow derived liver stem cells in peripheral blood on post-operative days #1, and #3.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To determine qualitatively and quantitatively whether bone marrow derived liver associated stem cells are mobilized from the bone marrow in patients undergoing major liver resections (3 or more liver segments).
Time Frame: conclusion of study
|
conclusion of study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To determine whether a difference exist in the baseline levels of bone marrow derived liver associated stem cells between normal healthy subjects/ volunteers and cancer patients prior to liver surgery.
Time Frame: conclusion of study
|
conclusion of study
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Ronald DeMatteo, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-017
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.