Immunophenotyping of Fresh Stromal Vascular Fraction From Adipose Derived Stem Cells (ADSC) Enriched Fat Grafts
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|ClinicalTrials.gov Identifier: NCT01771913|
Recruitment Status : Completed
First Posted : January 18, 2013
Results First Posted : August 24, 2015
Last Update Posted : August 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Breast Reconstruction Contour Irregularities Volume Insufficiency||Genetic: centrifuged fat graft Genetic: ADSCs enriched fat graft||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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.
- 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.
- 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.
- 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.
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
|Hospital Municipal Carmino Caricchio|
|Sao Paulo, Brazil, 03063-000|
|Study Chair:||Nivaldo Alonso, PhD||University of Sao Paulo|