Investigation of Stem Cells in Human Lipoaspirate

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Nevada, Las Vegas
Sponsor:
Information provided by (Responsible Party):
William A. Zamboni, M.D., University of Nevada, Las Vegas
ClinicalTrials.gov Identifier:
NCT01677520
First received: August 28, 2012
Last updated: May 1, 2014
Last verified: May 2014
  Purpose

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.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Investigation of Adipose-Derived Stem Cells in Human Lipoaspirate

Resource links provided by NLM:


Further study details as provided by University of Nevada, Las Vegas:

Primary Outcome Measures:
  • Percent of Viable ADSCs [ Time Frame: Day of Surgery ] [ Designated as safety issue: No ]
    Percent of viable ADSCs will be measured on fresh samples and samples refrigerated for different times.


Secondary Outcome Measures:
  • Percent of Apoptotic ADSCs [ Time Frame: Day of Surgery ] [ Designated as safety issue: No ]
    Percent of apoptotic ADSCs will be measured on fresh samples and on refrigerated samples at 1, 2, 3, and 4 days refrigerated storage.


Other Outcome Measures:
  • Percent of Necrotic ADSCs [ Time Frame: Day of Surgery ] [ Designated as safety issue: No ]
    Percent of necrotic ADSCs will be measured on fresh samples and on refrigerated samples at 1, 2, 3, and 4 days of refrigerated storage.


Biospecimen Retention:   Samples Without DNA

Cells from lipoaspirate maximum of 20 days


Estimated Enrollment: 240
Study Start Date: March 2011
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
18-30 yrs, 31-50 yrs, 51-70 yrs
No intervention

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary Care Clinic

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01677520

Contacts
Contact: William A Zamboni, M.D. 702-671-2278 wzamboni@medicine.nevada.edu
Contact: Linda L Stephenson, BS,MT(ASCP) 702-895-3315 lstephenson@medicine.nevada.edu

Locations
United States, Nevada
University of Nevada School of Medicine Patient Care Center Recruiting
Las Vegas, Nevada, United States, 89102
Contact: William A Zamboni, M.D.       wzamboni@medicine.nevada.edu   
Contact: Karen Zamboni, BSRN    702-671-5118    kzamboni@medicine.nevada.edu   
Principal Investigator: William A Zamboni, M.D.         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: William A. Zamboni, M.D., Professor and Chair Department of Surgery UNSOM, University of Nevada, Las Vegas
ClinicalTrials.gov Identifier: NCT01677520     History of Changes
Other Study ID Numbers: 12.08.004
Study First Received: August 28, 2012
Last Updated: May 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nevada, Las Vegas:
adipose-derived stem cells
viable ADSCs
apoptosis
necrosis
cryopreservation

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 20, 2014