Immunophenotyping of Fresh Stromal Vascular Fraction From Adipose Derived Stem Cells (ADSC) Enriched Fat Grafts
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2012
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 14, 2013
CompletedFirst Posted
Study publicly available on registry
January 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedResults Posted
Study results publicly available
August 24, 2015
CompletedAugust 24, 2015
July 1, 2015
2.5 years
January 14, 2013
June 25, 2015
July 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Immunophenotyping
baseline
Other Outcomes (1)
Number of Participants Experiencing Fat Necrosis in the Postoperative Period
up to 3 years
Study Arms (2)
centrifuged fat graft
SHAM COMPARATORfemale patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.
ADSCs enriched centrifuged fat graft
ACTIVE COMPARATORfemale patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- breast cancer patients under chemotherapy
- smokers
- bad health condition
- patients too thin
- patients that require a new reconstructive surgery (secondary reconstruction)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Municipal Carmino Caricchio
São Paulo, São Paulo, 03063-000, Brazil
Related Publications (4)
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.
PMID: 16217471RESULTZuk 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.
PMID: 11304456RESULTGimble 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.
PMID: 21461337RESULTYoshimura 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.
PMID: 17763894RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Luiz Alexandre Lorico Tissiani
- Organization
- Faculdade de Medicina - Universidade de Sao Paulo
Study Officials
- STUDY CHAIR
Nivaldo Alonso, PhD
University of Sao Paulo
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Chief of Breast Reconstructive Unit at Hospital Municipal Carmino Caricchio
Study Record Dates
First Submitted
January 14, 2013
First Posted
January 18, 2013
Study Start
March 1, 2012
Primary Completion
September 1, 2014
Study Completion
May 1, 2015
Last Updated
August 24, 2015
Results First Posted
August 24, 2015
Record last verified: 2015-07