Investigation of Stem Cells in Human Lipoaspirate
This study is currently recruiting participants.
Verified December 2012 by University of Nevada, Las Vegas
Sponsor:
University of Nevada, Las Vegas
Information provided by (Responsible Party):
William A. Zamboni, M.D., University of Nevada
ClinicalTrials.gov Identifier:
NCT01677520
First received: August 28, 2012
Last updated: December 13, 2012
Last verified: December 2012
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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 2015 |
| Estimated Primary Completion Date: | August 2015 (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
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 |
| ClinicalTrials.gov Identifier: | NCT01677520 History of Changes |
| Other Study ID Numbers: | 12.08.004 |
| Study First Received: | August 28, 2012 |
| Last Updated: | December 13, 2012 |
| 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 May 19, 2013