Stem Cells Found in the Abdominal Cavity in Humans

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Cedars-Sinai Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT00576264
First received: December 18, 2007
Last updated: June 24, 2011
Last verified: December 2007
  Purpose

The purpose of this research study is to determine the genotype (genetic composition) and phenotype (physical appearance) of cells derived from the abdominal cavity to determine whether stem cells are present.


Condition
Intra-abdominal Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Peritoneal Cavity Derived Stem Cells: A Pilot Study

Further study details as provided by Cedars-Sinai Medical Center:

Biospecimen Retention:   Samples With DNA

peritoneal fluid


Estimated Enrollment: 50
Study Start Date: April 2007
Estimated Study Completion Date: February 2012
Detailed Description:

The purpose of this study is to determine the presence and characterization of stem cells in human peritoneal cavity. Peritoneal lavage fluid from patients who undergo elective open abdomen will be collected for this purpose. Peritoneal lavage is normally a routine part of abdominal surgical procedure and usually is discarded after surgery. The patient will undergo surgical procedure as usual and there will be no added procedures during surgery.

This study will collect and analyze peritoneal fluid for the existence and characteristics of stem cells from 15 patients undergoing scheduled elective intra-abdominal surgery by designated surgeons at Cedars-Sinai Medical Center. The types of abdominal surgery could be open abdominal surgery or laparoscopic surgery. Peritoneal washing is routinely done in abdominal surgeries. We will collect these fluids to analyze whether stem cells exist in human peritoneal cavity. The fluids will be collected in a sterile fashion. The collected fluid will be further processed in the laboratory for the purpose of the study.

Medical record review will be conducted. Information collected will include age, gender, past and current medical history, current indication for intra-abdominal surgery, substance exposure history, medication history which will be obtained from review of patients' medical records. The information will be maintained using coded entry and there will be no link between patient identifiers to the study codes.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

subjects undergoing scheduled elective intra-abdominal surgery

Criteria

Inclusion Criteria:

  1. 20-60 years old
  2. Male or females who are scheduled to undergo elective abdomen surgery

Exclusion Criteria:

  1. Minors
  2. Pregnant women
  3. Known personal or family history of genetic disorders
  4. Known history of malignancy
  5. Known history of advanced liver or renal disease
  6. HIV Positive: only patients who have tested negative during routine testing of their donated blood prior to surgery will be included in the study.
  7. Hepatitis B and C positive
  8. Scheduled to undergo lap banding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00576264

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Colleen Sam, DO       samc@cshs.org   
Principal Investigator: Prediman K Shah, MD         
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Prediman K Shah, MD Cedars-Sinai Medical Center
  More Information

No publications provided

Responsible Party: Prediman Krishnan Shah, MD, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT00576264     History of Changes
Other Study ID Numbers: 11388
Study First Received: December 18, 2007
Last Updated: June 24, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
open abdominal surgery
abdominal laparoscopic surgery
peritoneal stem cells
patients scheduled for any type of elective intra-abdominal surgery at Cedars-Sinai Medical Center with designated surgeons

ClinicalTrials.gov processed this record on April 17, 2014