Trial Outcomes & Findings for A Phase 2 Study to Evaluate the Efficacy and Safety of JointStem in Treatment of Osteoarthritis (NCT NCT02674399)
NCT ID: NCT02674399
Last Updated: 2021-08-10
Results Overview
Comparing the baseline and 6-month WOMAC scores in JointStem group Score range: 0-2,400 A score of 2,400 represents the most severe impairment and 0 represents the least impairment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
Baseline and 6 months
Results posted on
2021-08-10
Participant Flow
Participant milestones
| Measure |
JointStem
JointStem : autologous adipose tissue derived mesenchymal stem cells (AdMSC) 1x10e8 cells At Visit 3 (Week 0, baseline), the randomized subject received a single intra-articular injection.
|
Synvisc-One
hyaluronic acid At Visit 3 (Week 0, baseline), the randomized subject received a single intra-articular injection.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
9
|
|
Overall Study
COMPLETED
|
17
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
JointStem
JointStem : autologous adipose tissue derived mesenchymal stem cells (AdMSC) 1x10e8 cells At Visit 3 (Week 0, baseline), the randomized subject received a single intra-articular injection.
|
Synvisc-One
hyaluronic acid At Visit 3 (Week 0, baseline), the randomized subject received a single intra-articular injection.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
A Phase 2 Study to Evaluate the Efficacy and Safety of JointStem in Treatment of Osteoarthritis
Baseline characteristics by cohort
| Measure |
JointStem
n=19 Participants
autologous adipose tissue derived mesenchymal stem cells (AdMSC)
JointStem
|
Synvisc-One
n=9 Participants
hyaluronic acid
Synvisc-One
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
BMI
|
26.903 kg/m^2
STANDARD_DEVIATION 4.1938 • n=5 Participants
|
24.572 kg/m^2
STANDARD_DEVIATION 4.6408 • n=7 Participants
|
26.154 kg/m^2
STANDARD_DEVIATION 4.3971 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Height
|
173.66 cm
STANDARD_DEVIATION 9.222 • n=5 Participants
|
169.46 cm
STANDARD_DEVIATION 10.073 • n=7 Participants
|
172.31 cm
STANDARD_DEVIATION 9.527 • n=5 Participants
|
|
Weight
|
81.31 kg
STANDARD_DEVIATION 14.642 • n=5 Participants
|
71.66 kg
STANDARD_DEVIATION 20.569 • n=7 Participants
|
78.2 kg
STANDARD_DEVIATION 17.01 • n=5 Participants
|
|
Age, Continuous
|
52.3 years
STANDARD_DEVIATION 6.98 • n=5 Participants
|
52.1 years
STANDARD_DEVIATION 9.56 • n=7 Participants
|
52.3 years
STANDARD_DEVIATION 7.72 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: The primary endpoints were evaluated only in the JointsStem group.
Comparing the baseline and 6-month WOMAC scores in JointStem group Score range: 0-2,400 A score of 2,400 represents the most severe impairment and 0 represents the least impairment
Outcome measures
| Measure |
JointStem
n=19 Participants
autologous adipose tissue derived mesenchymal stem cells (AdMSC)
JointStem
|
Synvisc-One
hyaluronic acid
Synvisc-One
|
|---|---|---|
|
Change From Baseline on Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score in JointStem Group
|
-20.121 score on a scale
Standard Deviation 21.0415
|
—
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: The primary endpoints were evaluated only in the JointsStem group.
Comparing the baseline and 6-month VAS scores in JointStem group Score range: 0-100 A score of 100 represents the most severe pain and 0 represents the least pain.
Outcome measures
| Measure |
JointStem
n=19 Participants
autologous adipose tissue derived mesenchymal stem cells (AdMSC)
JointStem
|
Synvisc-One
hyaluronic acid
Synvisc-One
|
|---|---|---|
|
Change From Baseline on Visual Analog Scale (VAS) in JointStem Group
|
-32.5 score on a scale
Standard Deviation 23.93
|
—
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The primary endpoints were evaluated only in the JointsStem group. And one patient was excluded from the table due to absence of MRI values.
Comparing the baseline and 6-month MRI improvement values in JointStem group MRI Improvement Evaluation was conducted by an MRI analysis company called 'Qmetrics'. The main radiological features evaluated were bone marrow edema, osteophytes, and cartilage. Certain features, such as the appearance of a new cartilage defect or increase in the size of existing cartilage defects or osteophytes, is generally considered an indication of osteoarthritic progression. Similarly, the diminishing in severity or size of existing abnormalities would generally be considered to be a healing(improving) response.
Outcome measures
| Measure |
JointStem
n=18 Participants
autologous adipose tissue derived mesenchymal stem cells (AdMSC)
JointStem
|
Synvisc-One
hyaluronic acid
Synvisc-One
|
|---|---|---|
|
MRI Improvement Evaluation in JointStem Group
Improvement
|
5 Participants
|
0 Participants
|
|
MRI Improvement Evaluation in JointStem Group
No Change
|
5 Participants
|
0 Participants
|
|
MRI Improvement Evaluation in JointStem Group
Progress
|
8 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsComparing the changes of WOMAC scores between JointStem and positive control groups at 6 months Score range: 0-2,400 A score of 2,400 represents the most severe impairment and 0 represents the least impairment
Outcome measures
| Measure |
JointStem
n=19 Participants
autologous adipose tissue derived mesenchymal stem cells (AdMSC)
JointStem
|
Synvisc-One
n=9 Participants
hyaluronic acid
Synvisc-One
|
|---|---|---|
|
Change From Baseline on WOMAC Between JointStem and Positive Control Groups
|
-20.505 score on a scale
Standard Error 3.665
|
-17.129 score on a scale
Standard Error 5.3281
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsComparing the changes of VAS scores between JointStem and positive control groups at 6 months Score range: 0-100 A score of 100 represents the most severe pain and 0 represents the least pain.
Outcome measures
| Measure |
JointStem
n=19 Participants
autologous adipose tissue derived mesenchymal stem cells (AdMSC)
JointStem
|
Synvisc-One
n=9 Participants
hyaluronic acid
Synvisc-One
|
|---|---|---|
|
Change From Baseline on VAS Between JointStem and Positive Control Groups
|
-31.9 score on a scale
Standard Error 4.90
|
-30.6 score on a scale
Standard Error 7.13
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsComparing the changes of KOOS values between JointStem and positive control groups at 6 months KOOS score = 100 - \[{(average score of each item) \* 100} / 4 \] Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment
Outcome measures
| Measure |
JointStem
n=19 Participants
autologous adipose tissue derived mesenchymal stem cells (AdMSC)
JointStem
|
Synvisc-One
n=9 Participants
hyaluronic acid
Synvisc-One
|
|---|---|---|
|
Change From Baseline on Knee Injury & Osteoarthritis Outcome Score (KOOS) Between JointStem and Positive Control Groups
Symptoms
|
9.70 score on a scale
Standard Error 2.888
|
14.83 score on a scale
Standard Error 4.22
|
|
Change From Baseline on Knee Injury & Osteoarthritis Outcome Score (KOOS) Between JointStem and Positive Control Groups
Pain
|
21.40 score on a scale
Standard Error 3.975
|
19.04 score on a scale
Standard Error 5.78
|
|
Change From Baseline on Knee Injury & Osteoarthritis Outcome Score (KOOS) Between JointStem and Positive Control Groups
ADL
|
18.53 score on a scale
Standard Error 3.937
|
15.94 score on a scale
Standard Error 5.72
|
|
Change From Baseline on Knee Injury & Osteoarthritis Outcome Score (KOOS) Between JointStem and Positive Control Groups
Sport/Rec
|
25.00 score on a scale
Standard Error 5.123
|
26.68 score on a scale
Standard Error 7.482
|
|
Change From Baseline on Knee Injury & Osteoarthritis Outcome Score (KOOS) Between JointStem and Positive Control Groups
QOL
|
22.68 score on a scale
Standard Error 5.383
|
11.15 score on a scale
Standard Error 7.884
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsComparing the changes of Lysholm Knee Scoring Scales between JointStem and positive control groups at 6 months Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment
Outcome measures
| Measure |
JointStem
n=19 Participants
autologous adipose tissue derived mesenchymal stem cells (AdMSC)
JointStem
|
Synvisc-One
n=9 Participants
hyaluronic acid
Synvisc-One
|
|---|---|---|
|
Change From Baseline on Lysholm Knee Scoring Scale Between JointStem and Positive Control Groups
|
18.9 score on a scale
Standard Error 3.97
|
19.9 score on a scale
Standard Error 5.78
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsComparing the changes of IKDC scores between JointStem and positive control groups at 6 months IKDC score = {(sum of each item score) / 87} \* 100 Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment
Outcome measures
| Measure |
JointStem
n=19 Participants
autologous adipose tissue derived mesenchymal stem cells (AdMSC)
JointStem
|
Synvisc-One
n=9 Participants
hyaluronic acid
Synvisc-One
|
|---|---|---|
|
Change From Baseline on International Knee Documentation Committee (IKDC) Between JointStem and Positive Control Groups
|
55.74 score on a scale
Standard Error 2.223
|
54.24 score on a scale
Standard Error 3.238
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsComparing the changes of RAND-36 scores between JointStem and positive control groups at 6 months Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment
Outcome measures
| Measure |
JointStem
n=19 Participants
autologous adipose tissue derived mesenchymal stem cells (AdMSC)
JointStem
|
Synvisc-One
n=9 Participants
hyaluronic acid
Synvisc-One
|
|---|---|---|
|
Change From Baseline on RAND-36 Score Between JointStem and Positive Control Groups
Physical Functioning
|
17.2 score on a scale
Standard Error 3.80
|
14.9 score on a scale
Standard Error 5.52
|
|
Change From Baseline on RAND-36 Score Between JointStem and Positive Control Groups
Role Limitation (Physical)
|
20.7 score on a scale
Standard Error 8.04
|
17.4 score on a scale
Standard Error 11.73
|
|
Change From Baseline on RAND-36 Score Between JointStem and Positive Control Groups
Role Limitation (Emotional)
|
6.7 score on a scale
Standard Error 6.615
|
-6.74 score on a scale
Standard Error 9.654
|
|
Change From Baseline on RAND-36 Score Between JointStem and Positive Control Groups
Energy/Fatigue
|
5.2 score on a scale
Standard Error 3.91
|
4.5 score on a scale
Standard Error 5.76
|
|
Change From Baseline on RAND-36 Score Between JointStem and Positive Control Groups
Emotional well-being
|
-3.4 score on a scale
Standard Error 2.31
|
0.5 score on a scale
Standard Error 3.45
|
|
Change From Baseline on RAND-36 Score Between JointStem and Positive Control Groups
Social Functioning
|
14.71 score on a scale
Standard Error 2.964
|
16.16 score on a scale
Standard Error 4.312
|
|
Change From Baseline on RAND-36 Score Between JointStem and Positive Control Groups
Pain
|
21.59 score on a scale
Standard Error 4.211
|
14.7 score on a scale
Standard Error 6.18
|
|
Change From Baseline on RAND-36 Score Between JointStem and Positive Control Groups
General Health
|
2.91 score on a scale
Standard Error 2.516
|
3.13 score on a scale
Standard Error 3.668
|
SECONDARY outcome
Timeframe: Baseline, 9 months and 12 monthsPopulation: This measure was evaluated only in the JointsStem group.
Comparing the baseline and 9-month/12-month WOMAC scores in JointStem group Score range: 0-2,400 A score of 2,400 represents the most severe impairment and 0 represents the least impairment
Outcome measures
| Measure |
JointStem
n=19 Participants
autologous adipose tissue derived mesenchymal stem cells (AdMSC)
JointStem
|
Synvisc-One
hyaluronic acid
Synvisc-One
|
|---|---|---|
|
Change From Baseline on WOMAC in JointStem Group
Change from baseline at Month 9
|
-21.216 score on a scale
Standard Deviation 20.9653
|
—
|
|
Change From Baseline on WOMAC in JointStem Group
Change from baseline at Month 12
|
-21.711 score on a scale
Standard Deviation 19.7521
|
—
|
SECONDARY outcome
Timeframe: Baseline, 9 months and 12 monthsPopulation: This measure was evaluated only in the JointsStem group.
Comparing the baseline and 9-month/12-month VAS scores in JointStem group Score range: 0-100 A score of 100 represents the most severe pain and 0 represents the least pain.
Outcome measures
| Measure |
JointStem
n=19 Participants
autologous adipose tissue derived mesenchymal stem cells (AdMSC)
JointStem
|
Synvisc-One
hyaluronic acid
Synvisc-One
|
|---|---|---|
|
Change From Baseline on VAS in JointStem Group
Change from baseline at Month 9
|
-31.5 score on a scale
Standard Deviation 25.52
|
—
|
|
Change From Baseline on VAS in JointStem Group
Change from baseline at Month 12
|
-35 score on a scale
Standard Deviation 24.56
|
—
|
SECONDARY outcome
Timeframe: Baseline, 6 months and 12 monthsPopulation: This measure was evaluated only in the JointsStem group. And one patient was excluded from the table due to absence of MRI values.
Comparing the baseline and 9-month/12-month MRI improvement values in JointStem group MRI Improvement Evaluation was conducted by an MRI analysis company called 'Qmetrics'. The main radiological features evaluated were bone marrow edema, osteophytes, and cartilage. Certain features, such as the appearance of a new cartilage defect or increase in the size of existing cartilage defects or osteophytes, is generally considered an indication of osteoarthritic progression. Similarly, the diminishing in severity or size of existing abnormalities would generally be considered to be a healing(improving) response.
Outcome measures
| Measure |
JointStem
n=18 Participants
autologous adipose tissue derived mesenchymal stem cells (AdMSC)
JointStem
|
Synvisc-One
hyaluronic acid
Synvisc-One
|
|---|---|---|
|
Comparison of MRI Improvement Evaluation in JointStem Group
Month 6 Improved -> Month 12 Improved
|
3 Participants
|
—
|
|
Comparison of MRI Improvement Evaluation in JointStem Group
Month 6 Improved -> Month 12 No Change
|
1 Participants
|
—
|
|
Comparison of MRI Improvement Evaluation in JointStem Group
Month 6 Improved -> Month 12 Progress
|
1 Participants
|
—
|
|
Comparison of MRI Improvement Evaluation in JointStem Group
Month 6 No Change -> Month 12 Improved
|
1 Participants
|
—
|
|
Comparison of MRI Improvement Evaluation in JointStem Group
Month 6 No Change -> Month 12 No Change
|
2 Participants
|
—
|
|
Comparison of MRI Improvement Evaluation in JointStem Group
Month 6 No Change -> Month 12 Progress
|
2 Participants
|
—
|
|
Comparison of MRI Improvement Evaluation in JointStem Group
Month 6 Progress -> Month 12 Improved
|
2 Participants
|
—
|
|
Comparison of MRI Improvement Evaluation in JointStem Group
Month 6 Progress -> Month 12 No Change
|
0 Participants
|
—
|
|
Comparison of MRI Improvement Evaluation in JointStem Group
Month 6 Progress -> Month 12 Progress
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 9 months and 12 monthsPopulation: This measure was evaluated only in the JointsStem group.
Comparing the baseline and 6-month/9-month/12-month Lysholm Knee Scoring Scale in JointStem group Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment
Outcome measures
| Measure |
JointStem
n=19 Participants
autologous adipose tissue derived mesenchymal stem cells (AdMSC)
JointStem
|
Synvisc-One
hyaluronic acid
Synvisc-One
|
|---|---|---|
|
Change of Lysholm Knee Scoring Scale From Baseline at Months 6, 9 and 12
Change from baseline at Month 6
|
18.3 score on a scale
Standard Deviation 22.29
|
—
|
|
Change of Lysholm Knee Scoring Scale From Baseline at Months 6, 9 and 12
Change from baseline at Month 9
|
16.1 score on a scale
Standard Deviation 25.34
|
—
|
|
Change of Lysholm Knee Scoring Scale From Baseline at Months 6, 9 and 12
Change from baseline at Month 12
|
17.1 score on a scale
Standard Deviation 23.78
|
—
|
SECONDARY outcome
Timeframe: baseline, 6 month, 9 month, 12 monthPopulation: This measure was evaluated only in the JointsStem group.
Comparing the baseline and 6-month/9-month/12-month KOOS scores in JointStem group KOOS score = 100 - \[{(average score of each item) \* 100} / 4 \] Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment
Outcome measures
| Measure |
JointStem
n=19 Participants
autologous adipose tissue derived mesenchymal stem cells (AdMSC)
JointStem
|
Synvisc-One
hyaluronic acid
Synvisc-One
|
|---|---|---|
|
Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 6 (ADL)
|
18.66 score on a scale
Standard Deviation 23.842
|
—
|
|
Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 6 (Symptoms)
|
9.02 score on a scale
Standard Deviation 15.381
|
—
|
|
Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 9 (Symptoms)
|
15.03 score on a scale
Standard Deviation 13.677
|
—
|
|
Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 12 (Symptoms)
|
15.41 score on a scale
Standard Deviation 18.229
|
—
|
|
Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 6 (Pain)
|
21.65 score on a scale
Standard Deviation 20.386
|
—
|
|
Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 9 (Pain)
|
23.98 score on a scale
Standard Deviation 23.200
|
—
|
|
Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 12 (Pain)
|
25.31 score on a scale
Standard Deviation 21.219
|
—
|
|
Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 9 (ADL)
|
18.42 score on a scale
Standard Deviation 25.017
|
—
|
|
Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 12 (ADL)
|
21.90 score on a scale
Standard Deviation 23.237
|
—
|
|
Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 6 (Sport/Rec)
|
25.53 score on a scale
Standard Deviation 23.915
|
—
|
|
Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 9 (Sport/Rec)
|
28.42 score on a scale
Standard Deviation 25.279
|
—
|
|
Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 12 (Sport/Rec)
|
33.68 score on a scale
Standard Deviation 24.486
|
—
|
|
Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 6 (QOL)
|
23.36 score on a scale
Standard Deviation 24.829
|
—
|
|
Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 9 (QOL)
|
29.95 score on a scale
Standard Deviation 27.228
|
—
|
|
Change of KOOS Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 12 (QOL)
|
28.96 score on a scale
Standard Deviation 29.121
|
—
|
SECONDARY outcome
Timeframe: baseline, 6 month, 9 month, 12 monthPopulation: This measure was evaluated only in the JointsStem group.
Comparing the baseline and 6-month/9-month/12-month IKDC scores in JointStem group IKDC score = {(sum of each item score) / 87} \* 100 Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment
Outcome measures
| Measure |
JointStem
n=19 Participants
autologous adipose tissue derived mesenchymal stem cells (AdMSC)
JointStem
|
Synvisc-One
hyaluronic acid
Synvisc-One
|
|---|---|---|
|
Change of IKDC Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 6
|
7.03 score on a scale
Standard Deviation 11.379
|
—
|
|
Change of IKDC Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 9
|
10.95 score on a scale
Standard Deviation 12.047
|
—
|
|
Change of IKDC Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 12
|
9.63 score on a scale
Standard Deviation 10.380
|
—
|
SECONDARY outcome
Timeframe: baseline, 6 month, 9 month, 12 monthPopulation: This measure was evaluated only in the JointsStem group
Comparing the baseline and 6-month/9-month/12-month RAND-36 scores in JointStem group Score range: 0-100 A score of 0 represents the most severe impairment and 100 represents the least impairment
Outcome measures
| Measure |
JointStem
n=19 Participants
autologous adipose tissue derived mesenchymal stem cells (AdMSC)
JointStem
|
Synvisc-One
hyaluronic acid
Synvisc-One
|
|---|---|---|
|
Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 6 (Physical Functioning)
|
17.4 score on a scale
Standard Deviation 22.13
|
—
|
|
Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 9 (Physical Functioning)
|
18.7 score on a scale
Standard Deviation 23.38
|
—
|
|
Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 12 (Physical Functioning)
|
17.1 score on a scale
Standard Deviation 28.69
|
—
|
|
Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 6 (Role Limitation_Physical)
|
22.4 score on a scale
Standard Deviation 36.22
|
—
|
|
Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 9 (Role Limitation_Physical)
|
30.3 score on a scale
Standard Deviation 38.71
|
—
|
|
Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 12 (Role Limitation_Physical)
|
31.6 score on a scale
Standard Deviation 40.69
|
—
|
|
Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 6 (Role Limitation_Emotional)
|
8.77 score on a scale
Standard Deviation 33.048
|
—
|
|
Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 9 (Role Limitation_Emotional)
|
7.02 score on a scale
Standard Deviation 30.604
|
—
|
|
Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 12 (Role Limitation_Emotional)
|
8.77 score on a scale
Standard Deviation 33.048
|
—
|
|
Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 6 (Energy/Fatigue)
|
2.9 score on a scale
Standard Deviation 20.70
|
—
|
|
Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 9 (Energy/Fatigue)
|
5.3 score on a scale
Standard Deviation 16.45
|
—
|
|
Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 12 (Energy/Fatigue)
|
7.6 score on a scale
Standard Deviation 18.81
|
—
|
|
Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 6 (Emotional well-being)
|
-3.4 score on a scale
Standard Deviation 10.61
|
—
|
|
Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 9 (Emotional well-being)
|
-3.6 score on a scale
Standard Deviation 11.31
|
—
|
|
Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 12 (Emotional well-being)
|
-4.0 score on a scale
Standard Deviation 14.79
|
—
|
|
Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 6 (Social Functioning)
|
13.82 score on a scale
Standard Deviation 23.531
|
—
|
|
Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 9 (Social Functioning)
|
14.47 score on a scale
Standard Deviation 20.943
|
—
|
|
Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 12 (Social Functioning)
|
7.24 score on a scale
Standard Deviation 25.109
|
—
|
|
Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 6 (Pain)
|
23.16 score on a scale
Standard Deviation 21.982
|
—
|
|
Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 9 (Pain)
|
23.95 score on a scale
Standard Deviation 22.100
|
—
|
|
Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 12 (Pain)
|
24.34 score on a scale
Standard Deviation 21.967
|
—
|
|
Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 6 (General Health)
|
3.51 score on a scale
Standard Deviation 13.566
|
—
|
|
Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 9 (General Health)
|
5.71 score on a scale
Standard Deviation 10.502
|
—
|
|
Change of RAND-36 Score From Baseline at Month 6, 9 and 12 for JointStem Group
Change from baseline at Month 12 (General Health)
|
2.85 score on a scale
Standard Deviation 18.636
|
—
|
Adverse Events
JointStem
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Synvisc-One
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 |
JointStem
n=19 participants at risk
autologous adipose tissue derived mesenchymal stem cells (AdMSC)
|
Synvisc-One
n=9 participants at risk
hyaluronic acid
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
36.8%
7/19 • 1 year
|
22.2%
2/9 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
26.3%
5/19 • 1 year
|
0.00%
0/9 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Stiff knees
|
21.1%
4/19 • 1 year
|
11.1%
1/9 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
1/19 • 1 year
|
0.00%
0/9 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.3%
1/19 • 1 year
|
0.00%
0/9 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/19 • 1 year
|
11.1%
1/9 • 1 year
|
|
General disorders
Injection site pain
|
47.4%
9/19 • 1 year
|
11.1%
1/9 • 1 year
|
|
General disorders
Injection site swelling
|
5.3%
1/19 • 1 year
|
0.00%
0/9 • 1 year
|
|
General disorders
Pain
|
5.3%
1/19 • 1 year
|
0.00%
0/9 • 1 year
|
|
Infections and infestations
Bronchitis
|
10.5%
2/19 • 1 year
|
11.1%
1/9 • 1 year
|
|
Infections and infestations
Nasopharyngitis
|
10.5%
2/19 • 1 year
|
0.00%
0/9 • 1 year
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
5.3%
1/19 • 1 year
|
0.00%
0/9 • 1 year
|
|
Infections and infestations
Herpes simplex
|
5.3%
1/19 • 1 year
|
0.00%
0/9 • 1 year
|
|
Infections and infestations
Influenza
|
5.3%
1/19 • 1 year
|
0.00%
0/9 • 1 year
|
|
Infections and infestations
Lower respiratory tract infection
|
5.3%
1/19 • 1 year
|
0.00%
0/9 • 1 year
|
|
Infections and infestations
Pneumonia
|
0.00%
0/19 • 1 year
|
11.1%
1/9 • 1 year
|
|
Infections and infestations
Sinusitis
|
5.3%
1/19 • 1 year
|
0.00%
0/9 • 1 year
|
|
Infections and infestations
Upper respiratory tract infection
|
5.3%
1/19 • 1 year
|
0.00%
0/9 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
5.3%
1/19 • 1 year
|
0.00%
0/9 • 1 year
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
10.5%
2/19 • 1 year
|
11.1%
1/9 • 1 year
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/19 • 1 year
|
11.1%
1/9 • 1 year
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
5.3%
1/19 • 1 year
|
0.00%
0/9 • 1 year
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
1/19 • 1 year
|
0.00%
0/9 • 1 year
|
|
Nervous system disorders
Headache
|
5.3%
1/19 • 1 year
|
0.00%
0/9 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
1/19 • 1 year
|
0.00%
0/9 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place