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

This study has been withdrawn prior to enrollment.
(Study was closed due to logistical issues.)
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00605800
First received: January 17, 2008
Last updated: March 18, 2009
Last verified: March 2009
  Purpose

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.


Condition Intervention
Liver Cancer
Other: blood drawn

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Bone Marrow Derived Adult Liver Stem Cell Recruitment After Major Liver Resections: Correlation With Liver Regeneration and Hepatic Function

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood


Enrollment: 0
Study Start Date: March 2006
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
normal healthy volunteers
Other: blood drawn
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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

MSKCC clinics Normal healthy volunteers

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605800

Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Ronald DeMatteo, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Ronald DeMatteo, M.D, Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00605800     History of Changes
Other Study ID Numbers: 06-017
Study First Received: January 17, 2008
Last Updated: March 18, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Liver resection

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on November 25, 2014