NCT01677520

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 3, 2012

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

January 9, 2015

Status Verified

January 1, 2015

Enrollment Period

7.4 years

First QC Date

August 28, 2012

Last Update Submit

January 8, 2015

Conditions

Keywords

adipose-derived stem cellsviable ADSCsapoptosisnecrosiscryopreservation

Outcome Measures

Primary Outcomes (1)

  • Percent of Viable ADSCs

    Percent of viable ADSCs will be measured on fresh samples and samples refrigerated for different times.

    Day of Surgery

Secondary Outcomes (1)

  • Percent of Apoptotic ADSCs

    Day of Surgery

Other Outcomes (1)

  • Percent of Necrotic ADSCs

    Day of Surgery

Study Arms (1)

18-30 yrs, 31-50 yrs, 51-70 yrs

No intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary Care Clinic

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nevada School of Medicine Patient Care Center

Las Vegas, Nevada, 89102, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cells from lipoaspirate maximum of 20 days

MeSH Terms

Conditions

Breast NeoplasmsNecrosis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • William A Zamboni, M.D.

    UNSOM

    PRINCIPAL INVESTIGATOR
  • Wei Z Wang, M.D.

    wwang@medicine.nevada.edu

    STUDY DIRECTOR

Central Study Contacts

William A Zamboni, M.D.

CONTACT

Shelley J Williams, M.S.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chair Department of Surgery UNSOM

Study Record Dates

First Submitted

August 28, 2012

First Posted

September 3, 2012

Study Start

March 1, 2011

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

January 9, 2015

Record last verified: 2015-01

Locations