Trial Outcomes & Findings for Immunophenotyping of Fresh Stromal Vascular Fraction From Adipose Derived Stem Cells (ADSC) Enriched Fat Grafts (NCT NCT01771913)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

up to 1 year

Results posted on

2015-08-24

Participant Flow

patients who have contour irregularities after any method of breast reconstruction. recruited from jan/2012 to august/2014.

Participant milestones

Participant milestones
Measure	Centrifuged Fat Graft 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.	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 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 Study STARTED	9	11
Overall Study COMPLETED	8	11
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Centrifuged Fat Graft 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.	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 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 Study Withdrawal by Subject	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Centrifuged Fat Graft n=8 Participants 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.	ADSCs Enriched Centrifuged Fat Graft n=11 Participants 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 n=19 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	49.8 years STANDARD_DEVIATION 11.5 • n=5 Participants	49.6 years STANDARD_DEVIATION 5.7 • n=7 Participants	49.7 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	11 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Brazil	8 participants n=5 Participants	11 participants n=7 Participants	19 participants n=5 Participants
breast volume	562.8 mL STANDARD_DEVIATION 187.7 • n=5 Participants	650.1 mL STANDARD_DEVIATION 206.8 • n=7 Participants	613.3 mL STANDARD_DEVIATION 198.5 • n=5 Participants

PRIMARY outcome

Timeframe: up to 1 year

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.

Outcome measures

Outcome measures
Measure	Centrifuged Fat Graft n=8 Participants 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.	ADSCs Enriched Centrifuged Fat Graft n=11 Participants 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.
Volume Maintenance	51.6 percentage of graft volume persistency Standard Deviation 18.4	78.9 percentage of graft volume persistency Standard Deviation 74.9

SECONDARY outcome

Timeframe: baseline

Population: we had technical problems in processing 4 tissue samples in each arm.

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.

Outcome measures

Outcome measures
Measure	Centrifuged Fat Graft n=4 Participants 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.	ADSCs Enriched Centrifuged Fat Graft n=7 Participants 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.
Immunophenotyping	27 percentage of expression for CD90 Standard Deviation 27.9	79 percentage of expression for CD90 Standard Deviation 15.4

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 3 years

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.

Outcome measures

Outcome measures
Measure	Centrifuged Fat Graft n=8 Participants 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.	ADSCs Enriched Centrifuged Fat Graft n=11 Participants 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.
Number of Participants Experiencing Fat Necrosis in the Postoperative Period	0 participants	4 participants

Adverse Events

Centrifuged Fat Graft

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ADSCs Enriched Centrifuged Fat Graft

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Luiz Alexandre Lorico Tissiani

Faculdade de Medicina - Universidade de Sao Paulo

Phone: 55-11-981798707

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place