Clinical trial NCT00605800: Bone Marrow Derived Adult Liver Stem Cell Recruitment After Major Liver Resections: Correlation With Liver Regeneration and Hepatic Function
Official title: Bone Marrow Derived Adult Liver Stem Cell Recruitment After Major Liver Resections: Correlation With Liver Regeneration and Hepatic Function
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Liver Cancer
Keywords: Liver resection
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-01-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MSKCC clinics Normal healthy volunteers

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.


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.

Primary outcomes:
measure: 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).
timeFrame: conclusion of study
Secondary outcomes:
measure: 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.
timeFrame: conclusion of study
Other outcomes:
Locations:
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Ronald DeMatteo, MD
role: PRINCIPAL_INVESTIGATOR
References: