Trial Outcomes & Findings for Adipose-derived SVF for the Treatment of Knee OA (NCT NCT02726945)
NCT ID: NCT02726945
Last Updated: 2025-04-25
Results Overview
Subjects will be monitored for serious and device related adverse events. Baseline MRIs will be compared to 1 year for any abnormal findings.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
up to 1 year
Results posted on
2025-04-25
Participant Flow
Recruitment opened April 2015 and the first subject was enrolled in the study in July 2016. Recruitment was completed in September 2017.
Participant milestones
| Measure |
Low Dose SVF
This group of subjects will receive a low dose of SVF (15 ± 2.5 x 10e6 SVF cells) for treatment of knee OA.
|
High Dose SVF
This group of subjects will receive a high dose of SVF (30 ± 2.5 x 10e6) SVF cells for treatment of knee OA.
|
Placebo
This group of subjects will receive a placebo with no SVF (0 SVF cells) for treatment of knee OA.
|
|---|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
13
|
|
Overall Study
COMPLETED
|
13
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Low Dose SVF
This group of subjects will receive a low dose of SVF (15 ± 2.5 x 10e6 SVF cells) for treatment of knee OA.
|
High Dose SVF
This group of subjects will receive a high dose of SVF (30 ± 2.5 x 10e6) SVF cells for treatment of knee OA.
|
Placebo
This group of subjects will receive a placebo with no SVF (0 SVF cells) for treatment of knee OA.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Overall Study
Elected to have total knee replacement
|
0
|
1
|
0
|
Baseline Characteristics
Adipose-derived SVF for the Treatment of Knee OA
Baseline characteristics by cohort
| Measure |
Low Dose SVF
n=13 Participants
This group of subjects will receive a low dose of SVF (15 ± 2.5 x 10e6 SVF cells) for treatment of knee OA.
|
High Dose SVF
n=13 Participants
This group of subjects will receive a high dose of SVF (30 ± 2.5 x 10e6) SVF cells for treatment of knee OA.
|
Placebo
n=13 Participants
This group of subjects will receive a placebo with no SVF (0 SVF cells) for treatment of knee OA.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.5 years
STANDARD_DEVIATION 7.9 • n=99 Participants
|
59.5 years
STANDARD_DEVIATION 11.7 • n=107 Participants
|
57.1 years
STANDARD_DEVIATION 9.1 • n=206 Participants
|
59.0 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
22 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
33 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
38 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=99 Participants
|
13 participants
n=107 Participants
|
13 participants
n=206 Participants
|
39 participants
n=7 Participants
|
|
Kellgren Lawrence Osteoarthritis Grade
KL Grade II
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Kellgren Lawrence Osteoarthritis Grade
KL Grade III
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
27 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: up to 1 yearPopulation: Thirty-eight subjects were monitored to 1 year. One subject was monitored for 6 weeks, when the subject withdrew from the study to receive a total knee replacement.
Subjects will be monitored for serious and device related adverse events. Baseline MRIs will be compared to 1 year for any abnormal findings.
Outcome measures
| Measure |
Low Dose SVF
n=13 Participants
This group of subjects will receive a low dose of SVF (15 ± 2.5 x 10e6 SVF cells) for treatment of knee OA.
|
High Dose SVF
n=13 Participants
This group of subjects will receive a high dose of SVF (30 ± 2.5 x 10e6) SVF cells for treatment of knee OA.
|
Placebo
n=13 Participants
This group of subjects will receive a placebo with no SVF (0 SVF cells) for treatment of knee OA.
|
|---|---|---|---|
|
Safety - Number of Participants With Treatment-Emergent Serious Adverse Events
Serious Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety - Number of Participants With Treatment-Emergent Serious Adverse Events
Device Related Serious Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety - Number of Participants With Treatment-Emergent Serious Adverse Events
MRI abnormalities
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: The data set was analyzed with an Intent-to-treat principle and used the last observation carried forward (LOCF) method for missing data.
The primary efficacy will be achieved if either dose group is shown to be superior to the placebo group at 6 months post-treatment, using the percent change in WOMAC score from baseline as the primary variable. The WOMAC score consists of 3 subscales, pain, stiffness and function. The overall score is normalized to a range of 0 to 100 points with a lower score indicating less symptoms of osteoarthritis.
Outcome measures
| Measure |
Low Dose SVF
n=13 Participants
This group of subjects will receive a low dose of SVF (15 ± 2.5 x 10e6 SVF cells) for treatment of knee OA.
|
High Dose SVF
n=13 Participants
This group of subjects will receive a high dose of SVF (30 ± 2.5 x 10e6) SVF cells for treatment of knee OA.
|
Placebo
n=13 Participants
This group of subjects will receive a placebo with no SVF (0 SVF cells) for treatment of knee OA.
|
|---|---|---|---|
|
Efficacy - Percent Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score From Baseline to 6 Months
|
52 percentage of change in WOMAC score
Interval 29.0 to 88.0
|
84 percentage of change in WOMAC score
Interval 19.0 to 91.0
|
25 percentage of change in WOMAC score
Interval -25.0 to 58.0
|
Adverse Events
Low Dose SVF
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
High Dose SVF
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Dose SVF
n=13 participants at risk
This group of subjects will receive a low dose of SVF (15 ± 2.5 x 10e6 SVF cells) for treatment of knee OA.
|
High Dose SVF
n=13 participants at risk
This group of subjects will receive a high dose of SVF (30 ± 2.5 x 10e6) SVF cells for treatment of knee OA.
|
Placebo
n=13 participants at risk
This group of subjects will receive a placebo with no SVF (0 SVF cells) for treatment of knee OA.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Swelling
|
0.00%
0/13 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/13 • 1 year
|
|
Infections and infestations
Possible Infection
|
7.7%
1/13 • Number of events 1 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/13 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place