Breast CancerNCT01677520
Investigation of Stem Cells in Human Lipoaspirate
An observational study of Breast Cancer, run by University of Nevada, Las Vegas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Breast Cancer
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary Care Clinic
Who may be able to join
- All adults (18-70 yrs) who have scheduled surgical lipectomy of the hips, abdomen, or thighs are prospective subjects for this study.
Who cannot join
- Pregnant women will be excluded to protect the unborn child.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Nevada School of Medicine Patient Care Center
Las Vegas, Nevada, 89102
William A Zamboni, M.D., wzamboni@medicine.nevada.edu
Karen Zamboni, BSRN, 702-671-5118, kzamboni@medicine.nevada.edu
About this study
Official title: 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.
- Conditions
- Breast Cancer
- Keywords
- adipose-derived stem cells, viable ADSCs, apoptosis, necrosis, cryopreservation
- Medical subject headings
- Breast Neoplasms, Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 18-30 yrs, 31-50 yrs, 51-70 yrs | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Viable ADSCs
Percent of viable ADSCs will be measured on fresh samples and samples refrigerated for different times.
Measured: Day of Surgery
Secondary outcomes (1)
Percent of Apoptotic ADSCs
Percent of apoptotic ADSCs will be measured on fresh samples and on refrigerated samples at 1, 2, 3, and 4 days refrigerated storage.
Measured: Day of Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study startMar 2011
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Las Vegas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William A. Zamboni, M.D., University of Nevada, Las Vegas
- Investigators
- William A Zamboni, M.D., Principal investigator, UNSOMWei Z Wang, M.D., Study director, wwang@medicine.nevada.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677520
- Sponsor's protocol ID
- 12.08.004
- Status last verified
- Jan 2015
- First submitted
- 28 Aug 2012
- Last updated
- 9 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Adipose-Derived Stem Cells in Human Lipoaspirate
- ClinicalTrials.gov ID
- NCT01677520
- Acronym / sponsor ID
- 12.08.004
- Conditions
- Breast Cancer
- Keywords
- adipose-derived stem cells, viable ADSCs, apoptosis, necrosis, cryopreservation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of Nevada, Las VegasUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 3 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18-30 yrs, 31-50 yrs, 51-70 yrs | – | –No intervention |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Clinic
Key inclusion criteria (1 listed)
- All adults (18-70 yrs) who have scheduled surgical lipectomy of the hips, abdomen, or thighs are prospective subjects for this study.
Key exclusion criteria (1 listed)
- Pregnant women will be excluded to protect the unborn child.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Percent of Apoptotic ADSCs
Time frame: Day of Surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William A Zamboni, M.D. principal investigator
UNSOM
Wei Z Wang, M.D. study director
wwang@medicine.nevada.edu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University of Nevada, Las Vegas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact William A Zamboni, M.D. (702-671-2278, wzamboni@medicine.nevada.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Viable ADSCs (time frame: Day of Surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2015.