Clinical trial NCT00576264: Stem Cells Found in the Abdominal Cavity in Humans
Official title: Peritoneal Cavity Derived Stem Cells: A Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intra-abdominal Surgery
Keywords: 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
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2007-12-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: subjects undergoing scheduled elective intra-abdominal surgery

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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Prediman K Shah, MD
role: PRINCIPAL_INVESTIGATOR
References: