Investigation of Stem Cells in Human Lipoaspirate

January 8, 2015 updated by: William A. Zamboni, M.D., University of Nevada, Las Vegas

Investigation of Adipose-Derived Stem Cells in Human Lipoaspirate

The overall purpose of this study is to enhance identification and isolation of ADSCs and adipocytes, to find the optimum culturing conditions to increase growth and volume of grafts, and to study the effects of cryopreservation on ADSCs and adipocytes. Fat injections are used in aesthetic surgery but tend to disassemble over time. If the investigators can enhance growth and volume of fat in culture, the investigators could use fat grafts in reconstruction of cancer and traumatic injury defects with the patients own cultured fat cells and grafts.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary Care Clinic

Description

Inclusion Criteria:

  • All adults (18-70 yrs) who have scheduled surgical lipectomy of the hips, abdomen, or thighs are prospective subjects for this study.

Exclusion Criteria:

  • Pregnant women will be excluded to protect the unborn child.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
18-30 yrs, 31-50 yrs, 51-70 yrs
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Viable ADSCs
Time Frame: Day of Surgery
Percent of viable ADSCs will be measured on fresh samples and samples refrigerated for different times.
Day of Surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Apoptotic ADSCs
Time Frame: Day of Surgery
Percent of apoptotic ADSCs will be measured on fresh samples and on refrigerated samples at 1, 2, 3, and 4 days refrigerated storage.
Day of Surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Necrotic ADSCs
Time Frame: Day of Surgery
Percent of necrotic ADSCs will be measured on fresh samples and on refrigerated samples at 1, 2, 3, and 4 days of refrigerated storage.
Day of Surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nevada, Las Vegas

Investigators

  • Principal Investigator: William A Zamboni, M.D., UNSOM
  • Study Director: Wei Z Wang, M.D., wwang@medicine.nevada.edu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

August 28, 2012

First Submitted That Met QC Criteria

August 31, 2012

First Posted (Estimate)

September 3, 2012

Study Record Updates

Last Update Posted (Estimate)

January 9, 2015

Last Update Submitted That Met QC Criteria

January 8, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 12.08.004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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