Stem Cells Found in the Abdominal Cavity in Humans | NCT00576264

Studies
Stem Cells Found in the Abdominal Cavity in Humans

NCT00576264

Sponsor

Cedars-Sinai Medical Center

Status

Unknown status

Last Update Posted

Jun 27, 2011Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Intra-abdominal Surgery

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Not provided

Completion Date

Feb 2012Estimated

First Submitted Date

Dec 18, 2007

First Submission Date that Met QC Criteria

Dec 18, 2007

First Posted Date

Dec 19, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 24, 2011

Last Update Posted Date

Jun 27, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Minors
Pregnant women
Known personal or family history of genetic disorders
Known history of malignancy
Known history of advanced liver or renal disease
HIV Positive: only patients who have tested negative during routine testing of their donated blood prior to surgery will be included in the study.
Hepatitis B and C positive
Scheduled to undergo lap banding

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

subjects undergoing scheduled elective intra-abdominal surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Prediman K Shah, MD	Cedars-Sinai Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cedars-Sinai Medical Center	Recruiting	Los Angeles	California	90048	United States