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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: University of Sao Paulo

Current Primary Outcome: Volume Maintenance [ Time Frame: up to 1 year ]

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.


Original Primary Outcome: Volume Maintenance [ Time Frame: up to 1 year ]

Current Secondary Outcome: Immunophenotyping [ Time Frame: baseline ]

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.


Original Secondary Outcome: Immunophenotyping [ Time Frame: at the day of intervention ]

immunophenotyping of the fresh stromal vascular fraction of both groups


Information By: University of Sao Paulo

Dates:
Date Received: January 14, 2013
Date Started: March 2012
Date Completion:
Last Updated: July 30, 2015
Last Verified: July 2015