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

University of Sao Paulo

Status and phase: Completed; Phase 2

Conditions: Breast Reconstruction; Contour Irregularities; Volume Insufficiency

Treatments: Genetic: ADSCs enriched fat graft; Genetic: centrifuged fat graft

Study type: Interventional

Funder types: Other

Identifiers

NCT01771913

boosteredADSCs

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Female

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

centrifuged fat graft

Sham Comparator group

Description:

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

Treatment:

Genetic: centrifuged fat graft

ADSCs enriched centrifuged fat graft

Active Comparator group

Description:

female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement

Treatment:

Genetic: ADSCs enriched fat graft