Trial Outcomes & Findings for Investigation of Mesenchymal Stem Cell Therapy for the Treatment of Osteoarthritis of the Knee (NCT NCT02958267)
NCT ID: NCT02958267
Last Updated: 2019-09-24
Results Overview
Subscales include pain, symptoms, function in activities of daily living, function in sport and recreation, and knee-related quality of life. Each subscale is 0-100 with 100 indicating the best possible score.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
Change from baseline to 3, 6, and 12 months post-treatment
Results posted on
2019-09-24
Participant Flow
Number of participants to be treated was capped at 30 participants. However, the approved protocol allowed enrollment of up to 45 participants to achieve a treatment group of 30 participants.
Based on the recruitment details stated, if a participant enrolled but subsequently withdrew or was withdrawn prior to treatment, another participant was enrolled in order to achieve a number of 30 participants who were treated within the study. Per protocol, consented patients could include up to 45 if needed to achieve 30 treated participants.
Participant milestones
| Measure |
BMAC Injection and PRP Injection
Injection of bone marrow aspirate concentrate (BMAC) withdrawn from a bone near the hip into the knee joint (intra-articular) immediately followed by an injection of platelet-rich plasma (PRP) into the knee joint.
BMAC injection: 60mL of bone marrow will be collected from a bone near the hip. Approximately 5-6mL of the bone marrow aspirate concentrate is then used for injection, under ultrasound guidance, into the target knee by the study physician.
PRP injection: 60mL of venous blood will be withdrawn from either arm. Approximately 4-5 ml of platelet-rich plasma will be introduced under ultrasound guidance to the subject's target knee by the study physician.
|
Gel-One® Hyaluronate Injection
Gel-One® is an hyaluronate gel used in the treatment of knee osteoarthritis by injection into the knee joint (intra-articular).
Gel-One® hyaluronate injection: Patients will receive a single injection of Gel-One® (3 ml syringe of Gel-One® - 1% solution \[10 mg/mL\], 30mg total hyaluronan) into the target knee. Injections will be performed by the study physician under real-time dynamic ultrasound guidance.
|
|---|---|---|
|
Enrollment
STARTED
|
17
|
15
|
|
Enrollment
COMPLETED
|
17
|
15
|
|
Enrollment
NOT COMPLETED
|
0
|
0
|
|
Enrollment to Actual Treatment Complete
STARTED
|
17
|
15
|
|
Enrollment to Actual Treatment Complete
COMPLETED
|
15
|
15
|
|
Enrollment to Actual Treatment Complete
NOT COMPLETED
|
2
|
0
|
|
Follow-up Visits
STARTED
|
15
|
15
|
|
Follow-up Visits
3 Month Follow-up
|
15
|
15
|
|
Follow-up Visits
6 Month Follow-up
|
14
|
14
|
|
Follow-up Visits
12 Month Follow-up
|
13
|
14
|
|
Follow-up Visits
COMPLETED
|
13
|
14
|
|
Follow-up Visits
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
BMAC Injection and PRP Injection
Injection of bone marrow aspirate concentrate (BMAC) withdrawn from a bone near the hip into the knee joint (intra-articular) immediately followed by an injection of platelet-rich plasma (PRP) into the knee joint.
BMAC injection: 60mL of bone marrow will be collected from a bone near the hip. Approximately 5-6mL of the bone marrow aspirate concentrate is then used for injection, under ultrasound guidance, into the target knee by the study physician.
PRP injection: 60mL of venous blood will be withdrawn from either arm. Approximately 4-5 ml of platelet-rich plasma will be introduced under ultrasound guidance to the subject's target knee by the study physician.
|
Gel-One® Hyaluronate Injection
Gel-One® is an hyaluronate gel used in the treatment of knee osteoarthritis by injection into the knee joint (intra-articular).
Gel-One® hyaluronate injection: Patients will receive a single injection of Gel-One® (3 ml syringe of Gel-One® - 1% solution \[10 mg/mL\], 30mg total hyaluronan) into the target knee. Injections will be performed by the study physician under real-time dynamic ultrasound guidance.
|
|---|---|---|
|
Enrollment to Actual Treatment Complete
Withdrawal by Subject
|
1
|
0
|
|
Enrollment to Actual Treatment Complete
Physician Decision
|
1
|
0
|
|
Follow-up Visits
Additional treatment pursued
|
2
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
BMAC Injection and PRP Injection
n=17 Participants
Injection of bone marrow aspirate concentrate (BMAC) withdrawn from a bone near the hip into the knee joint (intra-articular) immediately followed by an injection of platelet-rich plasma (PRP) into the knee joint.
BMAC injection: 60mL of bone marrow will be collected from a bone near the hip. Approximately 5-6mL of the bone marrow aspirate concentrate is then used for injection, under ultrasound guidance, into the target knee by the study physician.
PRP injection: 60mL of venous blood will be withdrawn from either arm. Approximately 4-5 ml of platelet-rich plasma will be introduced under ultrasound guidance to the subject's target knee by the study physician.
|
Gel-One® Hyaluronate Injection
n=15 Participants
Gel-One® is an hyaluronate gel used in the treatment of knee osteoarthritis by injection into the knee joint (intra-articular).
Gel-One® hyaluronate injection: Patients will receive a single injection of Gel-One® (3 ml syringe of Gel-One® - 1% solution \[10 mg/mL\], 30mg total hyaluronan) into the target knee. Injections will be performed by the study physician under real-time dynamic ultrasound guidance.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.06 years
STANDARD_DEVIATION 9.14 • n=17 Participants
|
58.60 years
STANDARD_DEVIATION 8.05 • n=15 Participants
|
58.31 years
STANDARD_DEVIATION 8.51 • n=32 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=17 Participants
|
5 Participants
n=15 Participants
|
13 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=17 Participants
|
10 Participants
n=15 Participants
|
19 Participants
n=32 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
BMI
|
29.19 kg/m^2
STANDARD_DEVIATION 5.19 • n=17 Participants
|
29.21 kg/m^2
STANDARD_DEVIATION 7.05 • n=15 Participants
|
29.20 kg/m^2
STANDARD_DEVIATION 6.03 • n=32 Participants
|
|
Previous surgery on target knee knee
No
|
7 Participants
n=17 Participants
|
6 Participants
n=15 Participants
|
13 Participants
n=32 Participants
|
|
Previous surgery on target knee knee
Yes
|
10 Participants
n=17 Participants
|
9 Participants
n=15 Participants
|
19 Participants
n=32 Participants
|
|
Previous injection on target knee
No
|
6 Participants
n=17 Participants
|
8 Participants
n=15 Participants
|
14 Participants
n=32 Participants
|
|
Previous injection on target knee
Yes
|
11 Participants
n=17 Participants
|
7 Participants
n=15 Participants
|
18 Participants
n=32 Participants
|
|
Previous physical therapy on target knee
No
|
4 Participants
n=17 Participants
|
9 Participants
n=15 Participants
|
13 Participants
n=32 Participants
|
|
Previous physical therapy on target knee
Yes
|
13 Participants
n=17 Participants
|
6 Participants
n=15 Participants
|
19 Participants
n=32 Participants
|
|
Onset/course of target knee
Traumatic
|
5 Participants
n=17 Participants
|
6 Participants
n=15 Participants
|
11 Participants
n=32 Participants
|
|
Onset/course of target knee
Insidious
|
12 Participants
n=17 Participants
|
9 Participants
n=15 Participants
|
21 Participants
n=32 Participants
|
|
Kellgren-Lawrence grade (n, %)
Grade 1
|
5 Participants
n=17 Participants
|
2 Participants
n=15 Participants
|
7 Participants
n=32 Participants
|
|
Kellgren-Lawrence grade (n, %)
Grade 2
|
6 Participants
n=17 Participants
|
8 Participants
n=15 Participants
|
14 Participants
n=32 Participants
|
|
Kellgren-Lawrence grade (n, %)
Grade 3
|
6 Participants
n=17 Participants
|
5 Participants
n=15 Participants
|
11 Participants
n=32 Participants
|
|
KOOS Pain
|
60.82 units on a scale
STANDARD_DEVIATION 15.05 • n=17 Participants
|
63.33 units on a scale
STANDARD_DEVIATION 17.72 • n=15 Participants
|
62.00 units on a scale
STANDARD_DEVIATION 16.13 • n=32 Participants
|
|
KOOS Symptoms
|
66.54 units on a scale
STANDARD_DEVIATION 16.01 • n=17 Participants
|
68.80 units on a scale
STANDARD_DEVIATION 15.69 • n=15 Participants
|
67.59 units on a scale
STANDARD_DEVIATION 15.65 • n=32 Participants
|
|
KOOS ADLs
|
68.59 units on a scale
STANDARD_DEVIATION 17.98 • n=17 Participants
|
70.13 units on a scale
STANDARD_DEVIATION 18.34 • n=15 Participants
|
69.31 units on a scale
STANDARD_DEVIATION 17.87 • n=32 Participants
|
|
KOOS Sport & Recreation
|
31.47 units on a scale
STANDARD_DEVIATION 23.57 • n=17 Participants
|
39.67 units on a scale
STANDARD_DEVIATION 21.59 • n=15 Participants
|
35.31 units on a scale
STANDARD_DEVIATION 22.68 • n=32 Participants
|
|
KOOS Quality of Life
|
36.18 units on a scale
STANDARD_DEVIATION 18.50 • n=17 Participants
|
38.47 units on a scale
STANDARD_DEVIATION 15.94 • n=15 Participants
|
37.25 units on a scale
STANDARD_DEVIATION 17.11 • n=32 Participants
|
|
NPRS
|
4.59 units on a scale
STANDARD_DEVIATION 1.84 • n=17 Participants
|
4.20 units on a scale
STANDARD_DEVIATION 1.70 • n=15 Participants
|
4.41 units on a scale
STANDARD_DEVIATION 1.76 • n=32 Participants
|
|
PROMIS Global Health Physical Score
|
44.62 units on a scale
STANDARD_DEVIATION 7.61 • n=17 Participants
|
48.23 units on a scale
STANDARD_DEVIATION 7.99 • n=15 Participants
|
46.31 units on a scale
STANDARD_DEVIATION 7.88 • n=32 Participants
|
|
PROMIS Global Health Mental Score
|
51.88 units on a scale
STANDARD_DEVIATION 5.02 • n=17 Participants
|
51.90 units on a scale
STANDARD_DEVIATION 9.36 • n=15 Participants
|
51.89 units on a scale
STANDARD_DEVIATION 7.25 • n=32 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to 3, 6, and 12 months post-treatmentPopulation: One participant in the BMAC injection and PRP injection group withdrew prior to the 6 month follow-up and another prior to the 12 month follow-up both due to the pursuit of an additional treatment option. One participant in the hyaluronate injection group withdrew prior to the 6 month follow-up due to pursuit of an additional treatment option.
Subscales include pain, symptoms, function in activities of daily living, function in sport and recreation, and knee-related quality of life. Each subscale is 0-100 with 100 indicating the best possible score.
Outcome measures
| Measure |
BMAC Injection and PRP Injection
n=15 Participants
Injection of bone marrow aspirate concentrate (BMAC) withdrawn from a bone near the hip into the knee joint (intra-articular) immediately followed by an injection of platelet-rich plasma (PRP) into the knee joint.
BMAC injection: 60mL of bone marrow will be collected from a bone near the hip. Approximately 5-6mL of the bone marrow aspirate concentrate is then used for injection, under ultrasound guidance, into the target knee by the study physician.
PRP injection: 60mL of venous blood will be withdrawn from either arm. Approximately 4-5 ml of platelet-rich plasma will be introduced under ultrasound guidance to the subject's target knee by the study physician.
|
Gel-One® Hyaluronate Injection
n=15 Participants
Gel-One® is an hyaluronate gel used in the treatment of knee osteoarthritis by injection into the knee joint (intra-articular).
Gel-One® hyaluronate injection: Patients will receive a single injection of Gel-One® (3 ml syringe of Gel-One® - 1% solution \[10 mg/mL\], 30mg total hyaluronan) into the target knee. Injections will be performed by the study physician under real-time dynamic ultrasound guidance.
|
|---|---|---|
|
Knee Injury and Osteoarthritis Outcome Score
KOOS Pain (3 months)
|
16.71 score on a scale
Interval 6.71 to 26.71
|
10.93 score on a scale
Interval 5.15 to 16.71
|
|
Knee Injury and Osteoarthritis Outcome Score
KOOS Symptoms (3 months)
|
14.00 score on a scale
Interval 4.38 to 23.63
|
10.47 score on a scale
Interval 3.48 to 17.45
|
|
Knee Injury and Osteoarthritis Outcome Score
KOOS ADL (3 months)
|
15.35 score on a scale
Interval 5.1 to 25.59
|
12.47 score on a scale
Interval 5.97 to 18.96
|
|
Knee Injury and Osteoarthritis Outcome Score
KOOS Sport (3 months)
|
29.46 score on a scale
Interval 13.02 to 45.91
|
30.07 score on a scale
Interval 18.71 to 41.43
|
|
Knee Injury and Osteoarthritis Outcome Score
KOOS QOL (3 months)
|
21.02 score on a scale
Interval 9.03 to 33.01
|
21.27 score on a scale
Interval 11.1 to 31.43
|
|
Knee Injury and Osteoarthritis Outcome Score
KOOS Pain (6 months)
|
20.03 score on a scale
Interval 10.71 to 29.36
|
12.52 score on a scale
Interval 3.16 to 21.89
|
|
Knee Injury and Osteoarthritis Outcome Score
KOOS Symptoms (6 months)
|
14.26 score on a scale
Interval 4.7 to 23.81
|
12.41 score on a scale
Interval 5.45 to 19.37
|
|
Knee Injury and Osteoarthritis Outcome Score
KOOS ADLs (6 months)
|
18.13 score on a scale
Interval 9.0 to 27.25
|
14.94 score on a scale
Interval 5.98 to 23.9
|
|
Knee Injury and Osteoarthritis Outcome Score
KOOS Sport (6 months)
|
34.89 score on a scale
Interval 19.9 to 49.88
|
31.62 score on a scale
Interval 16.41 to 46.82
|
|
Knee Injury and Osteoarthritis Outcome Score
KOOS QOL (6 months)
|
24.97 score on a scale
Interval 14.51 to 35.42
|
24.18 score on a scale
Interval 10.99 to 37.36
|
|
Knee Injury and Osteoarthritis Outcome Score
KOOS Pain (12 months)
|
23.48 score on a scale
Interval 14.85 to 32.12
|
12.67 score on a scale
Interval 2.62 to 22.71
|
|
Knee Injury and Osteoarthritis Outcome Score
KOOS Symptoms (12 months)
|
18.01 score on a scale
Interval 10.29 to 25.72
|
8.20 score on a scale
Interval 0.33 to 16.73
|
|
Knee Injury and Osteoarthritis Outcome Score
KOOS ADLs (12 months)
|
19.10 score on a scale
Interval 9.52 to 28.68
|
11.87 score on a scale
Interval 2.05 to 21.68
|
|
Knee Injury and Osteoarthritis Outcome Score
KOOS Sport (12 months)
|
39.07 score on a scale
Interval 22.0 to 56.13
|
26.05 score on a scale
Interval 13.16 to 38.93
|
|
Knee Injury and Osteoarthritis Outcome Score
KOOS QOL (12 months)
|
27.44 score on a scale
Interval 17.61 to 37.27
|
21.46 score on a scale
Interval 8.33 to 34.6
|
SECONDARY outcome
Timeframe: Change from baseline to 3, 6, and 12 months post-treatmentPopulation: One participant in the BMAC injection and PRP injection group withdrew prior to the 6 month follow-up and another prior to the 12 month follow-up both due to the pursuit of an additional treatment option. One participant in the hyaluronate injection group withdrew prior to the 6 month follow-up due to pursuit of an additional treatment option.
Scale from 0-10 with 0 representing "no pain" and 10 representing "worst imaginable pain"
Outcome measures
| Measure |
BMAC Injection and PRP Injection
n=15 Participants
Injection of bone marrow aspirate concentrate (BMAC) withdrawn from a bone near the hip into the knee joint (intra-articular) immediately followed by an injection of platelet-rich plasma (PRP) into the knee joint.
BMAC injection: 60mL of bone marrow will be collected from a bone near the hip. Approximately 5-6mL of the bone marrow aspirate concentrate is then used for injection, under ultrasound guidance, into the target knee by the study physician.
PRP injection: 60mL of venous blood will be withdrawn from either arm. Approximately 4-5 ml of platelet-rich plasma will be introduced under ultrasound guidance to the subject's target knee by the study physician.
|
Gel-One® Hyaluronate Injection
n=15 Participants
Gel-One® is an hyaluronate gel used in the treatment of knee osteoarthritis by injection into the knee joint (intra-articular).
Gel-One® hyaluronate injection: Patients will receive a single injection of Gel-One® (3 ml syringe of Gel-One® - 1% solution \[10 mg/mL\], 30mg total hyaluronan) into the target knee. Injections will be performed by the study physician under real-time dynamic ultrasound guidance.
|
|---|---|---|
|
Numeric Pain Rating Scale
NPRS (3 months)
|
-1.92 score on a scale
Interval -3.27 to -0.57
|
-1.87 score on a scale
Interval -2.76 to -0.97
|
|
Numeric Pain Rating Scale
NPRS (6 months)
|
-2.45 score on a scale
Interval -3.6 to -1.28
|
-1.77 score on a scale
Interval -2.55 to -0.99
|
|
Numeric Pain Rating Scale
NPRS (12 months)
|
-3.13 score on a scale
Interval -3.96 to -2.29
|
-1.56 score on a scale
Interval -2.59 to -0.53
|
SECONDARY outcome
Timeframe: Change from baseline to 3, 6, and 12 months post-treatmentPopulation: One participant in the BMAC injection and PRP injection group withdrew prior to the 6 month follow-up and another prior to the 12 month follow-up both due to the pursuit of an additional treatment option. One participant in the hyaluronate injection group withdrew prior to the 6 month follow-up due to pursuit of an additional treatment option.
The Patient Reported Outcomes Measurement Information System (PROMIS®) Global Health scale v1.1 contains 10 questions and produces two subscale scores: Global Physical Health (GPH) and Global Mental Health (GMH) (Hays, Bjorner, Revicki, Spritzer, \& Cella, 2009). Each subscale produces a raw score that is converted to a T score such that an average patient in the United States would have a subscale T score of 50 with a standard deviation of 10 points ("Global Health: A Brief Guide to the PROMIS® Global Health Instruments", 2017). A score higher than the mean indicates a more desirable score, and vice versa. A positive change score indicates an improvement, while a negative change score indicates a decline in score value.
Outcome measures
| Measure |
BMAC Injection and PRP Injection
n=15 Participants
Injection of bone marrow aspirate concentrate (BMAC) withdrawn from a bone near the hip into the knee joint (intra-articular) immediately followed by an injection of platelet-rich plasma (PRP) into the knee joint.
BMAC injection: 60mL of bone marrow will be collected from a bone near the hip. Approximately 5-6mL of the bone marrow aspirate concentrate is then used for injection, under ultrasound guidance, into the target knee by the study physician.
PRP injection: 60mL of venous blood will be withdrawn from either arm. Approximately 4-5 ml of platelet-rich plasma will be introduced under ultrasound guidance to the subject's target knee by the study physician.
|
Gel-One® Hyaluronate Injection
n=15 Participants
Gel-One® is an hyaluronate gel used in the treatment of knee osteoarthritis by injection into the knee joint (intra-articular).
Gel-One® hyaluronate injection: Patients will receive a single injection of Gel-One® (3 ml syringe of Gel-One® - 1% solution \[10 mg/mL\], 30mg total hyaluronan) into the target knee. Injections will be performed by the study physician under real-time dynamic ultrasound guidance.
|
|---|---|---|
|
Patient Reported Outcome Measurement Information System Global Health Scores
PROMIS Physical Health (3 months)
|
4.62 score on a scale
Interval 0.84 to 8.41
|
0.59 score on a scale
Interval -3.76 to 4.94
|
|
Patient Reported Outcome Measurement Information System Global Health Scores
PROMIS Mental Health (3 months)
|
-2.18 score on a scale
Interval -3.87 to -0.48
|
-0.65 score on a scale
Interval -5.13 to 5.83
|
|
Patient Reported Outcome Measurement Information System Global Health Scores
PROMIS Physical Health (6 months)
|
6.76 score on a scale
Interval 3.63 to 9.89
|
3.50 score on a scale
Interval 0.16 to 6.83
|
|
Patient Reported Outcome Measurement Information System Global Health Scores
PROMIS Mental Health (6 months)
|
-0.01 score on a scale
Interval -3.25 to 3.23
|
2.24 score on a scale
Interval -0.54 to 5.03
|
|
Patient Reported Outcome Measurement Information System Global Health Scores
PROMIS Physical Health (12 months)
|
4.77 score on a scale
Interval 1.99 to 7.54
|
3.26 score on a scale
Interval -0.36 to 6.88
|
|
Patient Reported Outcome Measurement Information System Global Health Scores
PROMIS Mental Health (12 months)
|
0.07 score on a scale
Interval -2.64 to 2.77
|
3.01 score on a scale
Interval -0.4 to 6.42
|
Adverse Events
BMAC Injection and PRP Injection
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Gel-One® Hyaluronate Injection
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 |
BMAC Injection and PRP Injection
n=17 participants at risk
Injection of bone marrow aspirate concentrate (BMAC) withdrawn from a bone near the hip into the knee joint (intra-articular) immediately followed by an injection of platelet-rich plasma (PRP) into the knee joint.
BMAC injection: 60mL of bone marrow will be collected from a bone near the hip. Approximately 5-6mL of the bone marrow aspirate concentrate is then used for injection, under ultrasound guidance, into the target knee by the study physician.
PRP injection: 60mL of venous blood will be withdrawn from either arm. Approximately 4-5 ml of platelet-rich plasma will be introduced under ultrasound guidance to the subject's target knee by the study physician.
|
Gel-One® Hyaluronate Injection
n=15 participants at risk
Gel-One® is an hyaluronate gel used in the treatment of knee osteoarthritis by injection into the knee joint (intra-articular).
Gel-One® hyaluronate injection: Patients will receive a single injection of Gel-One® (3 ml syringe of Gel-One® - 1% solution \[10 mg/mL\], 30mg total hyaluronan) into the target knee. Injections will be performed by the study physician under real-time dynamic ultrasound guidance.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea and vomiting
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from the time of informed consent/enrollment through approximately 12 months following each participant's treatment date or until participant withdrawal, whichever occurred first.
Included in this report are any adverse events considered unexpected and therefore not listed on the research protocol and informed consent documents as common or likely, less common, or rare risks.
|
0.00%
0/15 • Adverse events were collected from the time of informed consent/enrollment through approximately 12 months following each participant's treatment date or until participant withdrawal, whichever occurred first.
Included in this report are any adverse events considered unexpected and therefore not listed on the research protocol and informed consent documents as common or likely, less common, or rare risks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place