Trial Outcomes & Findings for Use of Concentrated Endogenous Autologous Adipose Stromal Cells in Fat Grafts for Craniofacial Trauma (NCT NCT01633892)
NCT ID: NCT01633892
Last Updated: 2017-08-03
Results Overview
High resolution CT scanning with 3D reconstruction at 0, 1, 3, and 9 months
TERMINATED
NA
5 participants
0, 1, 3, and 9 months
2017-08-03
Participant Flow
Participant milestones
| Measure |
Fat Grafting
Fat Grafting procedure designed to deliver an autologous fat graft admixed with autologous stromal vascular fraction (SVF) at a high cell dose.
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Concentrated Endogenous Autologous Adipose Stromal Cells in Fat Grafts for Craniofacial Trauma
Baseline characteristics by cohort
| Measure |
Fat Grafting
n=5 Participants
Fat Grafting procedure designed to deliver an autologous fat graft admixed with autologous stromal vascular fraction (SVF) at a high cell dose.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
|
Skin Volume (cc)
|
5 cc
STANDARD_DEVIATION 0 • n=99 Participants
|
|
Skin Thickness (mm)
|
5 mm
STANDARD_DEVIATION 0 • n=99 Participants
|
PRIMARY outcome
Timeframe: 0, 1, 3, and 9 monthsHigh resolution CT scanning with 3D reconstruction at 0, 1, 3, and 9 months
Outcome measures
| Measure |
Fat Grafting
n=5 Participants
Fat Grafting procedure designed to deliver an autologous fat graft admixed with autologous stromal vascular fraction (SVF) at a high cell dose.
|
|---|---|
|
Average Fat Graft Volume Facial Form From Baseline up to 9 Months
9 month
|
3.46 cc
Standard Deviation 3.42
|
|
Average Fat Graft Volume Facial Form From Baseline up to 9 Months
3 months
|
3.95 cc
Standard Deviation 3.77
|
|
Average Fat Graft Volume Facial Form From Baseline up to 9 Months
1 months
|
5.98 cc
Standard Deviation 5.80
|
|
Average Fat Graft Volume Facial Form From Baseline up to 9 Months
0 months
|
0 cc
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 0, 1, 3, and 9 monthsHigh resolution CT scanning with 3D reconstruction at 0, 1, 3, and 9 months
Outcome measures
| Measure |
Fat Grafting
n=5 Participants
Fat Grafting procedure designed to deliver an autologous fat graft admixed with autologous stromal vascular fraction (SVF) at a high cell dose.
|
|---|---|
|
Average Tissue Thickness From Baseline up to 9 Months
9 month
|
13.62 mm
Standard Deviation 5.96
|
|
Average Tissue Thickness From Baseline up to 9 Months
3 months
|
14.1 mm
Standard Deviation 5.76
|
|
Average Tissue Thickness From Baseline up to 9 Months
1 months
|
15.62 mm
Standard Deviation 5.89
|
|
Average Tissue Thickness From Baseline up to 9 Months
0 months
|
11.00 mm
Standard Deviation 5.78
|
SECONDARY outcome
Timeframe: 9 months1\) Social Avoidance and Distress Scale (SADS) uses a questionnaire including 28 true/false items, with scores ranging from 0-10. A "low" score is below 4, "high" is above 7; intermediate is between 4-7. 2) COPE scale asks the subject to indicate what he/she generally does and feels, when he/she experience stressful events. On a scale of 60-240 where the higher ends indicates the subject does this activity most frequently during stressful events; 3) The Satisfaction With Appearance Scale (SWAP) is a 14-item questionnaire, assessing both the subjective appraisal and social-behavioral components of body image, where the higher the score, the more satisfied subject is with procedure, ranging from 0-7 for a total possible score range between 0-98 .
Outcome measures
| Measure |
Fat Grafting
n=5 Participants
Fat Grafting procedure designed to deliver an autologous fat graft admixed with autologous stromal vascular fraction (SVF) at a high cell dose.
|
|---|---|
|
Measure Quality of Life in Subjects After Grafting Using Validated Psychosocial Measures.
SADS Scale
|
9.3 units on a scale, see outcome measure de
Standard Deviation 8.1
|
|
Measure Quality of Life in Subjects After Grafting Using Validated Psychosocial Measures.
COPE
|
67.2 units on a scale, see outcome measure de
Standard Deviation 14.5
|
|
Measure Quality of Life in Subjects After Grafting Using Validated Psychosocial Measures.
SWAP
|
18.8 units on a scale, see outcome measure de
Standard Deviation 22.1
|
SECONDARY outcome
Timeframe: time of fat grafting, up to 12 hours post-baselineCell assessment included stromal vascular fraction composition evaluated by flow cytometry.
Outcome measures
| Measure |
Fat Grafting
n=5 Participants
Fat Grafting procedure designed to deliver an autologous fat graft admixed with autologous stromal vascular fraction (SVF) at a high cell dose.
|
|---|---|
|
Composition of SVF
% Endothelial Cells
|
9.76 percentage of cells
Standard Deviation 6.24
|
|
Composition of SVF
% Pericytes
|
9.91 percentage of cells
Standard Deviation 5.22
|
|
Composition of SVF
% Supradventitial Stromal Cells
|
65.5 percentage of cells
Standard Deviation 12.5
|
SECONDARY outcome
Timeframe: time of surgery, up to 12 hours post-baselineCell assessment will include viable stromal vascular fraction per gram of lipoaspirate.
Outcome measures
| Measure |
Fat Grafting
n=5 Participants
Fat Grafting procedure designed to deliver an autologous fat graft admixed with autologous stromal vascular fraction (SVF) at a high cell dose.
|
|---|---|
|
Characterization of Adipose Stromal Cell (ASC) Function
|
23.444 mL of viable SVF per g of lipoaspirate
Standard Deviation 1.924
|
Adverse Events
Fat Grafting
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place