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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01771913
Recruitment Status : Completed
First Posted : January 18, 2013
Results First Posted : August 24, 2015
Last Update Posted : August 24, 2015
Sponsor:
Information provided by (Responsible Party):
Luiz Alexandre Lorico Tissiani, University of Sao Paulo

Study Description
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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.

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

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : March 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : May 2015
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01771913


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

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Responsible Party: Luiz Alexandre Lorico Tissiani, MD, Chief of Breast Reconstructive Unit at Hospital Municipal Carmino Caricchio, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01771913    
Other Study ID Numbers: boosteredADSCs
First Posted: January 18, 2013    Key Record Dates
Results First Posted: August 24, 2015
Last Update Posted: August 24, 2015
Last Verified: July 2015
Keywords provided by Luiz Alexandre Lorico Tissiani, University of Sao Paulo:
adipocytes
cell transplantations
mesenchymal stem cell
immunophenotyping
adipose tissue
 breast reconstruction
mammaplasty
magnetic resonance imaging
fat necrosis