Stem Cells Found in the Abdominal Cavity in Humans

Intra-abdominal Surgery Clinical Trial

Official title:

Peritoneal Cavity Derived Stem Cells: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00576264
• Other study ID #: 11388
• Status: Recruiting
• Phase: N/A
• First received: December 18, 2007
• Last updated: June 24, 2011
• Start date: April 2007
• Est. completion date: February 2012

Study information

• Verified date: December 2007
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Intra-abdominal Surgery

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States,