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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-05-31

Brief Summary

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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.

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Detailed Description

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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

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Breast Reconstruction Contour Irregularities Volume Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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centrifuged fat graft

female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.

Group Type SHAM_COMPARATOR

centrifuged fat graft

Intervention Type GENETIC

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.

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

Group Type ACTIVE_COMPARATOR

ADSCs enriched fat graft

Intervention Type GENETIC

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.

Interventions

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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.

Intervention Type 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.

Intervention Type GENETIC

Eligibility Criteria

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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)

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes