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

Breast Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01771913
• Other study ID #: boosteredADSCs
• Status: Completed
• Phase: Phase 2
• First received: January 14, 2013
• Last updated: July 30, 2015
• Start date: March 2012
• Est. completion date: May 2015

Study information

• Verified date: July 2015
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Comittee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Reconstruction
• Contour Irregularities
• Volume Insufficiency

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Hospital Municipal Carmino Caricchio	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

Gimble JM, Bunnell BA, Casteilla L, Jung JS, Yoshimura K. Phases I-III Clinical Trials Using Adult Stem Cells. Stem Cells Int. 2011 Feb 23;2010:604713. doi: 10.4061/2010/604713. — View Citation

Spear SL, Wilson HB, Lockwood MD. Fat injection to correct contour deformities in the reconstructed breast. Plast Reconstr Surg. 2005 Oct;116(5):1300-5. — View Citation

Yoshimura K, Sato K, Aoi N, Kurita M, Hirohi T, Harii K. Cell-assisted lipotransfer for cosmetic breast augmentation: supportive use of adipose-derived stem/stromal cells. Aesthetic Plast Surg. 2008 Jan;32(1):48-55; discussion 56-7. Epub 2007 Sep 1. — View Citation

Zuk PA, Zhu M, Mizuno H, Huang J, Futrell JW, Katz AJ, Benhaim P, Lorenz HP, Hedrick MH. Multilineage cells from human adipose tissue: implications for cell-based therapies. Tissue Eng. 2001 Apr;7(2):211-28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants Experiencing Fat Necrosis in the Postoperative Period	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.	up to 3 years	Yes
Primary	Volume Maintenance	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.	up to 1 year	Yes
Secondary	Immunophenotyping	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.	baseline	Yes