Trial Outcomes & Findings for The Effect of Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis (NCT NCT03467919)
NCT ID: NCT03467919
Last Updated: 2026-01-26
Results Overview
Patient reported outcome measure that reports a normalized score (100 indicating no symptoms and 0 indicating extreme symptoms).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
40 participants
Primary outcome timeframe
Baseline, 3, 6, 12, and 24 months
Results posted on
2026-01-26
Participant Flow
40 participants signed informed consent, 39 received randomized study injection and provided baseline information
Participant milestones
| Measure |
MFAT(Micro Fragmented Adipose Tissue)
Intra-articular knee injection of autologous Micro Fragmented Adipose Tissue harvested from the thigh using tumescent lipoaspiration and processing with minimal manipulation.
|
Conventional Therapy
Intra-articular injection of corticosteroid (Triamcinolone 40mg).
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
10
|
|
Overall Study
Received injection
|
30
|
10
|
|
Overall Study
Started study procedures
|
29
|
10
|
|
Overall Study
COMPLETED
|
27
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
MFAT(Micro Fragmented Adipose Tissue)
Intra-articular knee injection of autologous Micro Fragmented Adipose Tissue harvested from the thigh using tumescent lipoaspiration and processing with minimal manipulation.
|
Conventional Therapy
Intra-articular injection of corticosteroid (Triamcinolone 40mg).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
Baseline Characteristics
The Effect of Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
MFAT(Micro Fragmented Adipose Tissue)
n=29 Participants
Intra-articular knee injection of autologous Micro Fragmented Adipose Tissue harvested from the thigh using tumescent lipoaspiration and processing with minimal manipulation.
|
Conventional Therapy
n=10 Participants
Intra-articular injection of corticosteroid (Triamcinolone 40mg).
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.1 years
STANDARD_DEVIATION 11.0 • n=41 Participants
|
57.9 years
STANDARD_DEVIATION 11 • n=1581 Participants
|
57.3 years
STANDARD_DEVIATION 10.8 • n=4626 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=41 Participants
|
3 Participants
n=1581 Participants
|
19 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=41 Participants
|
7 Participants
n=1581 Participants
|
20 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=41 Participants
|
2 Participants
n=1581 Participants
|
8 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=41 Participants
|
7 Participants
n=1581 Participants
|
27 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=41 Participants
|
10 Participants
n=1581 Participants
|
39 Participants
n=4626 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3, 6, 12, and 24 monthsPopulation: Participants with data at the respective time point.
Patient reported outcome measure that reports a normalized score (100 indicating no symptoms and 0 indicating extreme symptoms).
Outcome measures
| Measure |
Conventional Therapy
n=10 Participants
Intra-articular injection of corticosteroid (Triamcinolone 40mg).
|
All Participants
n=39 Participants
Combined analysis of all participants.
|
MFAT(Micro Fragmented Adipose Tissue)
n=29 Participants
Intra-articular knee injection of autologous Micro Fragmented Adipose Tissue harvested from the thigh using tumescent lipoaspiration and processing with minimal manipulation.
|
|---|---|---|---|
|
Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Pain
Baseline
|
62.5 score on a scale
Standard Deviation 21.3
|
63.9 score on a scale
Standard Deviation 17.9
|
64.4 score on a scale
Standard Deviation 17.0
|
|
Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Pain
Change at 3 Months
|
8.6 score on a scale
Standard Deviation 22.8
|
12.0 score on a scale
Standard Deviation 18.0
|
13.2 score on a scale
Standard Deviation 16.4
|
|
Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Pain
Change at 6 Months
|
6.1 score on a scale
Standard Deviation 21.2
|
9.8 score on a scale
Standard Deviation 15.9
|
11.1 score on a scale
Standard Deviation 13.8
|
|
Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Pain
Change at 12 Months
|
14.2 score on a scale
Standard Deviation 21.6
|
11.6 score on a scale
Standard Deviation 22.4
|
10.8 score on a scale
Standard Deviation 23.0
|
|
Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Pain
Change at 24 Months
|
14.9 score on a scale
Standard Deviation 26.8
|
10.9 score on a scale
Standard Deviation 20.6
|
9.6 score on a scale
Standard Deviation 18.7
|
PRIMARY outcome
Timeframe: Baseline, 3, 6, 12, and 24 monthsPopulation: Participants with data at the respective time point.
Patient reported outcome measure that reports a normalized score (100 indicating no symptoms and 0 indicating extreme symptoms).
Outcome measures
| Measure |
Conventional Therapy
n=10 Participants
Intra-articular injection of corticosteroid (Triamcinolone 40mg).
|
All Participants
n=39 Participants
Combined analysis of all participants.
|
MFAT(Micro Fragmented Adipose Tissue)
n=29 Participants
Intra-articular knee injection of autologous Micro Fragmented Adipose Tissue harvested from the thigh using tumescent lipoaspiration and processing with minimal manipulation.
|
|---|---|---|---|
|
Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Symptoms
Baseline
|
47.5 score on a scale
Standard Deviation 19.3
|
48.6 score on a scale
Standard Deviation 15.5
|
49.0 score on a scale
Standard Deviation 14.3
|
|
Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Symptoms
Change at 3 Months
|
2.8 score on a scale
Standard Deviation 24.9
|
4.1 score on a scale
Standard Deviation 16.6
|
4.5 score on a scale
Standard Deviation 13.3
|
|
Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Symptoms
Change at 6 Months
|
6.1 score on a scale
Standard Deviation 16.1
|
7.0 score on a scale
Standard Deviation 14.9
|
7.2 score on a scale
Standard Deviation 14.7
|
|
Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Symptoms
Change at 12 Months
|
6.7 score on a scale
Standard Deviation 17.2
|
8.1 score on a scale
Standard Deviation 17.6
|
8.5 score on a scale
Standard Deviation 18.1
|
|
Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Symptoms
Change at 24 Months
|
13.8 score on a scale
Standard Deviation 16.7
|
7.8 score on a scale
Standard Deviation 13.6
|
5.9 score on a scale
Standard Deviation 12.2
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, 12, and 24 monthsPopulation: Participants with data at the respective time point.
Patient reported activity outcome measure on a scale of 0-100 (100 is best activity score)
Outcome measures
| Measure |
Conventional Therapy
n=10 Participants
Intra-articular injection of corticosteroid (Triamcinolone 40mg).
|
All Participants
n=39 Participants
Combined analysis of all participants.
|
MFAT(Micro Fragmented Adipose Tissue)
n=29 Participants
Intra-articular knee injection of autologous Micro Fragmented Adipose Tissue harvested from the thigh using tumescent lipoaspiration and processing with minimal manipulation.
|
|---|---|---|---|
|
Lysholm Score
Baseline
|
63.3 score on a scale
Standard Deviation 22.2
|
60.9 score on a scale
Standard Deviation 20.5
|
60.1 score on a scale
Standard Deviation 20.3
|
|
Lysholm Score
Change at 3 Months
|
6.3 score on a scale
Standard Deviation 20.6
|
9.1 score on a scale
Standard Deviation 18.1
|
10.1 score on a scale
Standard Deviation 17.5
|
|
Lysholm Score
Change at 6 Months
|
3.1 score on a scale
Standard Deviation 16.2
|
9.7 score on a scale
Standard Deviation 17
|
12 score on a scale
Standard Deviation 16.9
|
|
Lysholm Score
Change at 12 Months
|
5.4 score on a scale
Standard Deviation 24.2
|
11.9 score on a scale
Standard Deviation 21.4
|
14 score on a scale
Standard Deviation 20.4
|
|
Lysholm Score
Change at 24 Months
|
10.1 score on a scale
Standard Deviation 35.4
|
10.2 score on a scale
Standard Deviation 23.6
|
10.2 score on a scale
Standard Deviation 19.4
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, 12, and 24 monthsPopulation: Participants with data at the respective time point.
Patient reported quality of life outcome measure. VR-12 scores are reported as T-scores, which are standardized to have a mean of 50 and a standard deviation of 10 in the US population. Higher scores indicate better physical outcomes. Because this is a normalized range, there is theoretically no strict upper or lower bound. Most people will fall somewhere between 20-70 (+/- 3 SD).
Outcome measures
| Measure |
Conventional Therapy
n=10 Participants
Intra-articular injection of corticosteroid (Triamcinolone 40mg).
|
All Participants
n=39 Participants
Combined analysis of all participants.
|
MFAT(Micro Fragmented Adipose Tissue)
n=29 Participants
Intra-articular knee injection of autologous Micro Fragmented Adipose Tissue harvested from the thigh using tumescent lipoaspiration and processing with minimal manipulation.
|
|---|---|---|---|
|
Veterans RAND 12 (VR-12) Score - Physical
Baseline
|
42.5 T-score
Standard Deviation 7.0
|
42.8 T-score
Standard Deviation 7.2
|
42.9 T-score
Standard Deviation 7.4
|
|
Veterans RAND 12 (VR-12) Score - Physical
Change at 3 Months
|
4.6 T-score
Standard Deviation 5.0
|
3.7 T-score
Standard Deviation 7.1
|
3.4 T-score
Standard Deviation 7.7
|
|
Veterans RAND 12 (VR-12) Score - Physical
Change at 6 Months
|
3.4 T-score
Standard Deviation 6.2
|
3.8 T-score
Standard Deviation 7.4
|
4.0 T-score
Standard Deviation 7.9
|
|
Veterans RAND 12 (VR-12) Score - Physical
Change at 12 Months
|
5 T-score
Standard Deviation 6.6
|
5.3 T-score
Standard Deviation 8
|
5.4 T-score
Standard Deviation 8.5
|
|
Veterans RAND 12 (VR-12) Score - Physical
Change at 24 Months
|
1.8 T-score
Standard Deviation 9.9
|
4.1 T-score
Standard Deviation 8.3
|
4.9 T-score
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: Baseline, 3, 6, 12, and 24 monthsPopulation: Participants with data at the respective time point.
Patient reported quality of life outcome measure. VR-12 scores are reported as T-scores, which are standardized to have a mean of 50 and a standard deviation of 10 in the US population. Higher scores indicate better mental outcomes. Because this is a normalized range, there is theoretically no strict upper or lower bound. Most people will fall somewhere between 20-70 (+/- 3 SD).
Outcome measures
| Measure |
Conventional Therapy
n=10 Participants
Intra-articular injection of corticosteroid (Triamcinolone 40mg).
|
All Participants
n=39 Participants
Combined analysis of all participants.
|
MFAT(Micro Fragmented Adipose Tissue)
n=29 Participants
Intra-articular knee injection of autologous Micro Fragmented Adipose Tissue harvested from the thigh using tumescent lipoaspiration and processing with minimal manipulation.
|
|---|---|---|---|
|
Veterans RAND 12 (VR-12) Score - Mental
Change at 3 Months
|
-4.3 T-score
Standard Deviation 10.2
|
-2.3 T-score
Standard Deviation 8.5
|
-1.6 T-score
Standard Deviation 8
|
|
Veterans RAND 12 (VR-12) Score - Mental
Change at 6 Months
|
-3.5 T-score
Standard Deviation 8.7
|
-2.6 T-score
Standard Deviation 7
|
-2.3 T-score
Standard Deviation 6.4
|
|
Veterans RAND 12 (VR-12) Score - Mental
Change at 12 Months
|
-5.7 T-score
Standard Deviation 7.5
|
-3.1 T-score
Standard Deviation 7.7
|
-2.2 T-score
Standard Deviation 7.7
|
|
Veterans RAND 12 (VR-12) Score - Mental
Change at 24 Months
|
-2.0 T-score
Standard Deviation 8.7
|
-1.4 T-score
Standard Deviation 6.6
|
-0.9 T-score
Standard Deviation 6
|
|
Veterans RAND 12 (VR-12) Score - Mental
Baseline
|
58.7 T-score
Standard Deviation 9.4
|
56.6 T-score
Standard Deviation 8.9
|
55.9 T-score
Standard Deviation 8.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsCartilage thickness on MRI using T2-weighted cartilage mapping
Outcome measures
Outcome data not reported
Adverse Events
MFAT(Micro Fragmented Adipose Tissue)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Conventional Therapy
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place