Trial Outcomes & Findings for Effect of Concentrating Endogenous Stromal Cells in the Fat Graft Using TGI Device (NCT NCT01924364)
NCT ID: NCT01924364
Last Updated: 2018-05-11
Results Overview
Facial appearance and persistence of treatment effect will be assessed using high resolution CT scanning with 3D reconstruction. Patients will be followed for 24 months after treatment to define long term outcomes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
Surgical visit, PO Study visits month 3, month 9, month 12, and month 24
Results posted on
2018-05-11
Participant Flow
Participant milestones
| Measure |
Fat Grafting
Same patient received either fat graft treatment supplemented with TGI or no TGI, randomized per site.
|
|---|---|
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Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Fat Grafting
Same patient received either fat graft treatment supplemented with TGI or no TGI, randomized per site.
|
|---|---|
|
Overall Study
Physician Decision
|
3
|
Baseline Characteristics
Effect of Concentrating Endogenous Stromal Cells in the Fat Graft Using TGI Device
Baseline characteristics by cohort
| Measure |
Fat Grafting
n=7 Participants
Tissue Genesis Cell Isolation System™ (CIS): In this study, we will concentrate the adipose stromal cells (ASCs) in the fat graft material to assess whether this modification will increase fat graft retention over time. The concentrated fat to be injected into the subject from the fat grafting procedure will be processed by the Tissue Genesis Cell Isolation System™ (CIS) device. The volume retention in areas treated with ASC concentrated fat grafts will be compared with regions treated with standard fat grafts in the same patient. Additionally, data from our current study assessing volume retention after fat grafting for facial deformities (IRB # PRO09060101) will be used for comparison.
|
|---|---|
|
Age, Continuous
|
53.3 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
|
Employment
Full time
|
1 Participants
n=5 Participants
|
|
Employment
Part time
|
1 Participants
n=5 Participants
|
|
Employment
Unemployed
|
4 Participants
n=5 Participants
|
|
Employment
Retired
|
1 Participants
n=5 Participants
|
|
Smoker
Smoker, current
|
2 Participants
n=5 Participants
|
|
Smoker
Smoker, former
|
0 Participants
n=5 Participants
|
|
Smoker
Never smoker
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Surgical visit, PO Study visits month 3, month 9, month 12, and month 24Facial appearance and persistence of treatment effect will be assessed using high resolution CT scanning with 3D reconstruction. Patients will be followed for 24 months after treatment to define long term outcomes.
Outcome measures
| Measure |
TGI_Fat Volume Injected
n=4 Participants
|
TGI_Facial Volume at 3 Month PO
n=4 Participants
Facial volume at 3 month post-operative
|
TGI_Facial Volume at 9 Month PO
n=4 Participants
Facial volume at 9 month PO
|
TGI_Facial Volume at 12 Month PO
n=4 Participants
Facial volume at 12 month post-operative
|
TGI_Facial Volume at 24 Month PO
n=4 Participants
Facial volume at 24 month PO
|
Standard_Fat Volume Injected
n=4 Participants
|
Standard_Facial Volume at 3 Month PO
n=4 Participants
Standard\_Facial volume at 3 month PO
|
Standard_Facial Volume at 9 Month PO
n=4 Participants
Facial volume at 9 month PO
|
Standard_Facial Volume at 12 Month PO
n=4 Participants
Standard\_Facial volume at 12 month PO
|
Standard_Facial Volume at 24 Month PO
n=4 Participants
Standard\_Facial volume at 24 month PO
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Total Fat Volume Injected and Facial Volume Postop
|
11.4 mL
Standard Deviation 1.4
|
79.8 mL
Standard Deviation 14.9
|
49.6 mL
Standard Deviation 20.0
|
52.8 mL
Standard Deviation 15.5
|
42.4 mL
Standard Deviation 28.4
|
10.1 mL
Standard Deviation 8.6
|
86.9 mL
Standard Deviation 19.5
|
73.0 mL
Standard Deviation 25.5
|
71.9 mL
Standard Deviation 26.6
|
62.5 mL
Standard Deviation 32.4
|
SECONDARY outcome
Timeframe: Surgical visitthis describes the biologic properties of the cells within the fat graft
Outcome measures
| Measure |
TGI_Fat Volume Injected
n=4 Participants
|
TGI_Facial Volume at 3 Month PO
n=4 Participants
Facial volume at 3 month post-operative
|
TGI_Facial Volume at 9 Month PO
Facial volume at 9 month PO
|
TGI_Facial Volume at 12 Month PO
Facial volume at 12 month post-operative
|
TGI_Facial Volume at 24 Month PO
Facial volume at 24 month PO
|
Standard_Fat Volume Injected
|
Standard_Facial Volume at 3 Month PO
Standard\_Facial volume at 3 month PO
|
Standard_Facial Volume at 9 Month PO
Facial volume at 9 month PO
|
Standard_Facial Volume at 12 Month PO
Standard\_Facial volume at 12 month PO
|
Standard_Facial Volume at 24 Month PO
Standard\_Facial volume at 24 month PO
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Adipose Stem Cell Yield Per Volume of Fat Tissue
|
73.54 %age of cells yield/volume of fat tissue
Standard Deviation 8.85
|
70.48 %age of cells yield/volume of fat tissue
Standard Deviation 5.60
|
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Adverse Events
Fat Grafting
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fat Grafting
n=7 participants at risk
Tissue Genesis Cell Isolation System™ (TGI CIS): In this study, we will concentrate the adipose stromal cells (ASCs) in the fat graft material to assess whether this modification will increase fat graft retention over time. The concentrated fat to be injected into the subject from the fat grafting procedure will be processed by the Tissue Genesis Cell Isolation System™ (TGI CIS) device. The volume retention in areas treated with ASC concentrated fat grafts will be compared with regions treated with standard fat grafts in the same patient.
|
|---|---|
|
General disorders
Bruising
|
57.1%
4/7 • Number of events 4
|
Additional Information
Danielle Minteer
University of Pittsburgh Plastic Surgery
Phone: 412-383-4804
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place