Phase 2
N=20
Immunophenotyping of Fresh Stromal Vascular Fraction From Adipose Derived Stem Cells (ADSC) Enriched Fat Grafts
Breast Reconstruction · Contour Irregularities · Volume Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT01771913 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcome: Primary: Volume Maintenance — 51.6; 78.9 percentage of graft volume persistency — p=0.310
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- centrifuged fat graft (Genetic); ADSCs enriched fat graft (Genetic)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- Female
- Sponsor
- University of Sao Paulo
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Volume Maintenance |
51.6; 78.9 | 0.310 |
| SECONDARY Immunophenotyping |
27; 79 | 0.026 sig |
Summary
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01771913). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.