NCT01771913

Immunophenotyping of Fresh Stromal Vascular Fraction From Adipose Derived Stem Cells (ADSC) Enriched Fat Grafts

Immunophenotyping of Fresh Stromal Vascular Fraction From Adipose Derived Stem Cells (ADSC) Enriched Fat Grafts for Refinements of Reconstructed Breasts

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: Female
• Age: 20 Years – 70 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Breast Reconstruction
• Contour Irregularities
• Volume Insufficiency

Interventions

Type	Name	Description
GENETIC	centrifuged fat graft	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.
GENETIC	ADSCs enriched fat graft	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.

Timeline

• Start date: 2012-03-01
• Primary completion: 2014-09-01
• Completion: 2015-05-01
• First posted: 2013-01-18
• Last updated: 2015-08-24
• Results posted: 2015-08-24

Locations

1 site across 1 country: Brazil