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Trial record 15 of 109 for:    stromal vascular fraction

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
Sponsor:
Information provided by (Responsible Party):
Luiz Alexandre Lorico Tissiani, University of Sao Paulo

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Breast Reconstruction
Contour Irregularities
Volume Insufficiency
Interventions Genetic: centrifuged fat graft
Genetic: ADSCs enriched fat graft
Enrollment 20
Recruitment Details patients who have contour irregularities after any method of breast reconstruction. recruited from jan/2012 to august/2014.
Pre-assignment Details  
Arm/Group Title Centrifuged Fat Graft ADSCs Enriched Centrifuged Fat Graft
Hide Arm/Group Description

female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.

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.

female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement

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.

Period Title: Overall Study
Started 9 11
Completed 8 11
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title Centrifuged Fat Graft ADSCs Enriched Centrifuged Fat Graft Total
Hide Arm/Group Description

female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.

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.

female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement

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.

Total of all reporting groups
Overall Number of Baseline Participants 8 11 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 11 participants 19 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
  87.5%
11
 100.0%
18
  94.7%
>=65 years
1
  12.5%
0
   0.0%
1
   5.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 11 participants 19 participants
49.8  (11.5) 49.6  (5.7) 49.7  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 11 participants 19 participants
Female
8
 100.0%
11
 100.0%
19
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 8 participants 11 participants 19 participants
8 11 19
breast volume  
Mean (Standard Deviation)
Unit of measure:  mL
Number Analyzed 8 participants 11 participants 19 participants
562.8  (187.7) 650.1  (206.8) 613.3  (198.5)
1.Primary Outcome
Title Volume Maintenance
Hide Description 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.
Time Frame up to 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Centrifuged Fat Graft ADSCs Enriched Centrifuged Fat Graft
Hide Arm/Group Description:

female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.

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.

female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement

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.

Overall Number of Participants Analyzed 8 11
Mean (Standard Deviation)
Unit of Measure: percentage of graft volume persistency
51.6  (18.4) 78.9  (74.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Centrifuged Fat Graft, ADSCs Enriched Centrifuged Fat Graft
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.310
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Immunophenotyping
Hide Description 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.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
we had technical problems in processing 4 tissue samples in each arm.
Arm/Group Title Centrifuged Fat Graft ADSCs Enriched Centrifuged Fat Graft
Hide Arm/Group Description:

female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.

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.

female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement

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.

Overall Number of Participants Analyzed 4 7
Mean (Standard Deviation)
Unit of Measure: percentage of expression for CD90
27  (27.9) 79  (15.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Centrifuged Fat Graft, ADSCs Enriched Centrifuged Fat Graft
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Other Pre-specified Outcome
Title Number of Participants Experiencing Fat Necrosis in the Postoperative Period
Hide Description 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.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Centrifuged Fat Graft ADSCs Enriched Centrifuged Fat Graft
Hide Arm/Group Description:

female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.

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.

female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement

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.

Overall Number of Participants Analyzed 8 11
Measure Type: Number
Unit of Measure: participants
0 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Centrifuged Fat Graft, ADSCs Enriched Centrifuged Fat Graft
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.103
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame from fat grafting to 3 years (average) for ADSC arm and 16 months for the centrifuged arm.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Centrifuged Fat Graft ADSCs Enriched Centrifuged Fat Graft
Hide Arm/Group Description

female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.

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.

female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement

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.

All-Cause Mortality
Centrifuged Fat Graft ADSCs Enriched Centrifuged Fat Graft
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Centrifuged Fat Graft ADSCs Enriched Centrifuged Fat Graft
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Centrifuged Fat Graft ADSCs Enriched Centrifuged Fat Graft
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/11 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Luiz Alexandre Lorico Tissiani
Organization: Faculdade de Medicina - Universidade de Sao Paulo
Phone: 55-11-981798707
Responsible Party: Luiz Alexandre Lorico Tissiani, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01771913     History of Changes
Other Study ID Numbers: boosteredADSCs
First Submitted: January 14, 2013
First Posted: January 18, 2013
Results First Submitted: June 25, 2015
Results First Posted: August 24, 2015
Last Update Posted: August 24, 2015