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Completed

NCT Number: NCT01771913

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

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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Key information

Conditions

Breast Reconstruction Contour Irregularities Fat Necrosis Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Volume Insufficiency

Age range

20 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Municipal Carmino Caricchio

São Paulo, 03063-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

centrifuged fat graft

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 fat graft

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. Number of Participants Experiencing Fat Necrosis in the Postoperative Period

    Time frame: up to 3 years

    Fat necrosis may occur whenever a fat graft is performed and it has clinical relevance. It can emerge as oil cysts or small nodules a little bit painful. In mammograms of normal breasts, fat necrosis present as cysts or micro calcifications that present a benign appearance. In breast reconstruction patients, fat necrosis, despite its benign characteristics, can suggest cancer recurrence.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Jan 18, 2013
Registry last updated
Aug 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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