- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01771913
Immunophenotyping of Fresh Stromal Vascular Fraction From Adipose Derived Stem Cells (ADSC) Enriched Fat Grafts
July 30, 2015 updated by: Luiz Alexandre Lorico Tissiani, University of Sao Paulo
Immunophenotyping of Fresh Stromal Vascular Fraction From Adipose Derived Stem Cells (ADSC) Enriched Fat Grafts for Refinements of Reconstructed Breasts
The purpose of this study is to investigate if there is a relationship between the take of fat grafts with and without ADSCs and the presence of specific surface markers on the cells of the stromal vascular fraction.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Two groups of patients will be studied.
The control will receive centrifuged fat grafts while the other group will receive centrifuged enriched fat grafts with ADSCs.
The performance of both grafts will be assessed through volume measurement employing MRI before and after 6 months post-op.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
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
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Sao Paulo, Brazil, 03063-000
- Hospital Municipal Carmino Caricchio
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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
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- contour irregularities and volume insufficiency in reconstructed breasts no matter the method of reconstruction employed
- local flaps with conditions to receive fat grafts
- good health condition
Exclusion Criteria:
- breast cancer patients under chemotherapy
- smokers
- bad health condition
- patients too thin
- patients that require a new reconstructive surgery (secondary reconstruction)
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
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: centrifuged fat graft
female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.
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fat from the abdominal subcutaneous tissue will be taken by vacuum assisted lipectomy and immediately prepared to be grafted in the reconstructed breast that presents contour irregularities and/or volume insufficiency.
No adipose derived stem cells will enrich the fat grafts in this group.
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Active Comparator: ADSCs enriched centrifuged fat graft
female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement
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fat from the abdominal subcutaneous tissue will be taken by suction assisted lipectomy and stromal vascular fraction will be isolated and immediately added to the fat graft that will be employed to improve contour irregularities and volume insufficiency of reconstructed breasts.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Volume Maintenance
Time Frame: up to 1 year
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Volumetry of the reconstructed breasts will be accomplished through MRI and OsiriX software.
Osirix software allows breast volume calculation through the determination of regions of interest (ROIs) on an MRI sequence.
Once the pre (V1) and postoperative (V2) volumes were determined the following formula was applied: (V2 - V1) X 100/graft volume.
The result, expressed in percentage, expresses graft volume persistence.
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up to 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunophenotyping
Time Frame: baseline
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Immunophenotyping of the fresh stromal vascular fraction of both groups.
Immunophenotyping or flow cytometry measures how many cells, in a sample, express a specific surface marker.
A surface marker or a group of markers may characterize a specific cell type.
The software that accompanies the flow cytometer determines the number of cells (in percentage) that express the tested surface marker.
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baseline
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Experiencing Fat Necrosis in the Postoperative Period
Time Frame: up to 3 years
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Fat necrosis may occur whenever a fat graft is performed and it has clinical relevance.
It can emerge as oil cysts or small nodules a little bit painful.
In mammograms of normal breasts, fat necrosis present as cysts or micro calcifications that present a benign appearance.
In breast reconstruction patients, fat necrosis, despite its benign characteristics, can suggest cancer recurrence.
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up to 3 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Nivaldo Alonso, PhD, University of Sao Paulo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Yoshimura K, Sato K, Aoi N, Kurita M, Hirohi T, Harii K. Cell-assisted lipotransfer for cosmetic breast augmentation: supportive use of adipose-derived stem/stromal cells. Aesthetic Plast Surg. 2008 Jan;32(1):48-55; discussion 56-7. doi: 10.1007/s00266-007-9019-4. Epub 2007 Sep 1.
- Spear SL, Wilson HB, Lockwood MD. Fat injection to correct contour deformities in the reconstructed breast. Plast Reconstr Surg. 2005 Oct;116(5):1300-5. doi: 10.1097/01.prs.0000181509.67319.cf.
- Zuk PA, Zhu M, Mizuno H, Huang J, Futrell JW, Katz AJ, Benhaim P, Lorenz HP, Hedrick MH. Multilineage cells from human adipose tissue: implications for cell-based therapies. Tissue Eng. 2001 Apr;7(2):211-28. doi: 10.1089/107632701300062859.
- Gimble JM, Bunnell BA, Casteilla L, Jung JS, Yoshimura K. Phases I-III Clinical Trials Using Adult Stem Cells. Stem Cells Int. 2011 Feb 23;2010:604713. doi: 10.4061/2010/604713. No abstract available.
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, 2012
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
January 14, 2013
First Submitted That Met QC Criteria
January 16, 2013
First Posted (Estimate)
January 18, 2013
Study Record Updates
Last Update Posted (Estimate)
August 24, 2015
Last Update Submitted That Met QC Criteria
July 30, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- boosteredADSCs
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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