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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Luiz Alexandre Lorico Tissiani, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01771913
First received: January 14, 2013
Last updated: January 20, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Breast Reconstruction
Contour Irregularities
Volume Insufficiency
Genetic: centrifuged fat graft
Genetic: ADSCs enriched fat graft
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Volume maintenance [ Time Frame: up to 1 year ] [ Designated as safety issue: Yes ]
    volumetry of the reconstructed breasts will be accomplished through MRI and appropriate software (MRI before and after the interventions)


Secondary Outcome Measures:
  • immunophenotyping [ Time Frame: at the day of intervention ] [ Designated as safety issue: Yes ]
    immunophenotyping of the fresh stromal vascular fraction of both groups


Other Outcome Measures:
  • fat necrosis [ Time Frame: up to 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: March 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   20 Years to 70 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01771913

Contacts
Contact: Luiz Alexandre L Tissiani, MD 55-11-981798707 latissiani@gmail.com
Contact: Nivaldo Alonso, PhD 55-11-981494320 nivalonso@gmail.com

Locations
Brazil
Hospital Municipal Carmino Caricchio Recruiting
Sao Paulo, Brazil, 03063-000
Contact: Magali Cortezan, Agendamento    55-11-33946980      
Principal Investigator: Luiz Alexandre L Tissiani, MD         
Sponsors and Collaborators
University of Sao Paulo
Investigators
Study Chair: Nivaldo Alonso, PhD University of Sao Paulo
  More Information

Publications:
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     History of Changes
Other Study ID Numbers: boosteredADSCs
Study First Received: January 14, 2013
Last Updated: January 20, 2013
Health Authority: Brazil: National Comittee of Ethics in Research

Keywords provided by University of Sao Paulo:
adipocytes
cell transplantations
mesenchymal stem cell
immunophenotyping
adipose tissue
breast reconstruction
mammaplasty
magnetic resonance imaging
fat necrosis

ClinicalTrials.gov processed this record on August 21, 2014