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

NCT00605800 | Withdrawn

• 1 other identifier: 06-017
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

Liver resection

Outcome Measures

Primary Outcomes (1)

• 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).

  conclusion of study

Secondary Outcomes (1)

• 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.

  conclusion of study

Study Arms (2)

1

normal healthy volunteers

Other: blood drawn

2

Patients undergoing major liver resections

Other: blood drawn

Interventions

blood drawn OTHER

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MSKCC clinics Normal healthy volunteers

You may qualify if:

• 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.
• Normal healthy volunteers (control).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Related Links

• Memorial Sloan-Kettering Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Ronald DeMatteo, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 17, 2008
• First Posted: January 31, 2008
• Study Start: March 1, 2006
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: March 19, 2009

Record last verified: 2009-03