Stem Cells Found in the Abdominal Cavity in Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00576264
Recruitment Status : Unknown
Verified December 2007 by Cedars-Sinai Medical Center.
Recruitment status was:  Recruiting
First Posted : December 19, 2007
Last Update Posted : June 27, 2011
Information provided by:
Cedars-Sinai Medical Center

Brief Summary:
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 or disease
Intra-abdominal Surgery

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.

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Peritoneal Cavity Derived Stem Cells: A Pilot Study
Study Start Date : April 2007
Estimated Study Completion Date : February 2012

Biospecimen Retention:   Samples With DNA
peritoneal fluid

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
subjects undergoing scheduled elective intra-abdominal surgery

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00576264

United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Colleen Sam, DO   
Principal Investigator: Prediman K Shah, MD         
Sponsors and Collaborators
Cedars-Sinai Medical Center
Principal Investigator: Prediman K Shah, MD Cedars-Sinai Medical Center

Responsible Party: Prediman Krishnan Shah, MD, Cedars-Sinai Medical Center Identifier: NCT00576264     History of Changes
Other Study ID Numbers: 11388
First Posted: December 19, 2007    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: December 2007

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