Bone Marrow Derived Adult Liver Stem Cell Recruitment After Major Liver Resections: Correlation With Liver Regeneration and Hepatic Function

NCT ID: NCT00605800

Last Updated: 2009-03-19

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2009-03-31

Brief Summary

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.

Conditions

Liver Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

1

normal healthy volunteers

blood drawn

Intervention Type: OTHER

Baseline levels of bone marrow derived liver stem cells from normal healthy volunteers, which will be drawn once Two 5ml blue tubes).

2

Patients undergoing major liver resections

blood drawn

Intervention Type: OTHER

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.

Interventions

blood drawn

Baseline levels of bone marrow derived liver stem cells from normal healthy volunteers, which will be drawn once Two 5ml blue tubes).

Intervention Type: OTHER

blood drawn

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Memorial Sloan-Kettering Cancer Center

Principal Investigators

Ronald DeMatteo, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Related Links

http://www.mskcc.org

Memorial Sloan-Kettering Cancer Center

Other Identifiers

06-017

Identifier Type: -

Identifier Source: org_study_id