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

Phase 2

Completed

• Conditions: Contour Irregularities; Breast Reconstruction; Volume Insufficiency
• Interventions: Genetic: centrifuged fat graft; Genetic: ADSCs enriched fat graft

• Registration Number: NCT01771913
• Lead Sponsor: University of Sao Paulo

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 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2013-01-14
• Study First Submitted QC: 2013-01-16
• Study First Posted: 2013-01-18
• Primary Completion: 2014-09
• Study Completion: 2015-05
• Results First Submitted: 2015-06-25
• Status Verified: 2015-07
• Results First Submitted QC: 2015-07-30
• Last Update Submitted: 2015-07-30
• Results First Posted: 2015-08-24
• Last Update Posted: 2015-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

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Exclusion Criteria

• breast cancer patients under chemotherapy
• smokers
• bad health condition
• patients too thin
• patients that require a new reconstructive surgery (secondary reconstruction)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
centrifuged fat graft	centrifuged fat graft	female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.
ADSCs enriched centrifuged fat graft	ADSCs enriched fat graft	female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement

Primary Outcome Measures

Name	Time	Method
Volume Maintenance	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.

Secondary Outcome Measures

Name	Time	Method
Immunophenotyping	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.

Trial Locations

Locations (1)

Hospital Municipal Carmino Caricchio; 🇧🇷 Sao Paulo, Brazil