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

This study has been completed.
Information provided by (Responsible Party):
Luiz Alexandre Lorico Tissiani, University of Sao Paulo Identifier:
First received: January 14, 2013
Last updated: July 30, 2015
Last verified: July 2015
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.

Condition Intervention Phase
Breast Reconstruction
Contour Irregularities
Volume Insufficiency
Genetic: centrifuged fat graft
Genetic: ADSCs enriched fat graft
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Immunophenotyping of Fresh Stromal Vascular Fraction From Adipose Derived Stem Cells (ADSC) Enriched Fat Grafts for Refinements of Reconstructed Breasts

Resource links provided by NLM:

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Volume Maintenance [ Time Frame: up to 1 year ] [ Designated as safety issue: Yes ]
    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:
  • Immunophenotyping [ Time Frame: baseline ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Number of Participants Experiencing Fat Necrosis in the Postoperative Period [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
    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.

Enrollment: 20
Study Start Date: March 2012
Study Completion Date: May 2015
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: centrifuged fat graft
female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.
Genetic: 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.
Active Comparator: 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
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.

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.

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01771913

Hospital Municipal Carmino Caricchio
Sao Paulo, Brazil, 03063-000
Sponsors and Collaborators
University of Sao Paulo
Study Chair: Nivaldo Alonso, PhD University of Sao Paulo
  More Information

Responsible Party: Luiz Alexandre Lorico Tissiani, MD, Chief of Breast Reconstructive Unit at Hospital Municipal Carmino Caricchio, University of Sao Paulo Identifier: NCT01771913     History of Changes
Other Study ID Numbers: boosteredADSCs
Study First Received: January 14, 2013
Results First Received: June 25, 2015
Last Updated: July 30, 2015
Health Authority: Brazil: National Comittee of Ethics in Research

Keywords provided by University of Sao Paulo:
cell transplantations
mesenchymal stem cell
adipose tissue
breast reconstruction
magnetic resonance imaging
fat necrosis processed this record on November 25, 2015