Clinical trial NCT01771913: Immunophenotyping of Fresh Stromal Vascular Fraction From Adipose Derived Stem Cells (ADSC) Enriched Fat Grafts
Official title: Immunophenotyping of Fresh Stromal Vascular Fraction From Adipose Derived Stem Cells (ADSC) Enriched Fat Grafts for Refinements of Reconstructed Breasts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Reconstruction
Contour Irregularities
Volume Insufficiency
Keywords: adipocytes
cell transplantations
mesenchymal stem cell
immunophenotyping
adipose tissue
breast reconstruction
mammaplasty
magnetic resonance imaging
fat necrosis
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2013-01-18
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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)

Primary outcomes:
measure: Volume Maintenance
timeFrame: up to 1 year
Secondary outcomes:
measure: Immunophenotyping
timeFrame: baseline
Other outcomes:
measure: Number of Participants Experiencing Fat Necrosis in the Postoperative Period
timeFrame: up to 3 years
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital Municipal Carmino Caricchio
Study officials:
affiliation: University of Sao Paulo
name: Nivaldo Alonso, PhD
role: STUDY_CHAIR
References:
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. doi: 10.1097/01.prs.0000181509.67319.cf.
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. doi: 10.1089/107632701300062859.
citation: 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. No abstract available.
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. doi: 10.1007/s00266-007-9019-4. Epub 2007 Sep 1.