Trial Outcomes & Findings for Autologous Conditioned Plasma (ACP) Intra-articular (IA) Injections for Knee Osteoarthritis (OA) (NCT NCT02713542)
NCT ID: NCT02713542
Last Updated: 2019-08-13
Results Overview
The WOMAC Pain score will be used to measure outcome, the score ranges from 0 to 20. The higher the score indicates greater pain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
6 month visit
Results posted on
2019-08-13
Participant Flow
A total of 126 patients were evaluated and 90 were treated at four sites
A total of 36 patients were excluded before randomization to groups due to not meeting Inclusion/Exclusion criteria.
Participant milestones
| Measure |
Autologous Conditioned Plasma (ACP)
3 Intra-articular (IA) injections at 1 week intervals
ACP: Autologous Conditioned Plasma
|
Normal Saline (NS)
3 NS Intra-articular (IA) injections at 1 week intervals
Placebo: Three Normal Saline IA injections of 3-8 mL at 1-week intervals.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
30
|
|
Overall Study
COMPLETED
|
42
|
24
|
|
Overall Study
NOT COMPLETED
|
18
|
6
|
Reasons for withdrawal
| Measure |
Autologous Conditioned Plasma (ACP)
3 Intra-articular (IA) injections at 1 week intervals
ACP: Autologous Conditioned Plasma
|
Normal Saline (NS)
3 NS Intra-articular (IA) injections at 1 week intervals
Placebo: Three Normal Saline IA injections of 3-8 mL at 1-week intervals.
|
|---|---|---|
|
Overall Study
Use of prohibited medication
|
14
|
5
|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
Baseline Characteristics
Autologous Conditioned Plasma (ACP) Intra-articular (IA) Injections for Knee Osteoarthritis (OA)
Baseline characteristics by cohort
| Measure |
Experimental: Autologous Conditioned Plasma (ACP)
n=60 Participants
Three Intra-articular injections of ACP in knee at 1 week intervals
|
Control: Normal Saline (NS)
n=30 Participants
Three Intra-articular injections of NS in knee knee at 1 week intervals
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 10.3 • n=93 Participants
|
50.6 years
STANDARD_DEVIATION 10.9 • n=4 Participants
|
51.3 years
STANDARD_DEVIATION 10.6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
49 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
46 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
23 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=93 Participants
|
30 participants
n=4 Participants
|
90 participants
n=27 Participants
|
|
WOMAC pain score of at least 8
|
60 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
90 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 month visitThe WOMAC Pain score will be used to measure outcome, the score ranges from 0 to 20. The higher the score indicates greater pain.
Outcome measures
| Measure |
Autologous Conditioned Plasma
n=42 Participants
3 Intra-articular injections of ACP in knee at 1 week intervals
|
Normal Saline
n=24 Participants
3 Intra-articular injections of NS in knee at 1 week intervals
|
|---|---|---|
|
Pain Scores Measured by Western Ontario and McMaster Universities Index (WOMAC) Survey
|
3.98 units on a scale
Interval 0.0 to 17.0
|
5.54 units on a scale
Interval 0.0 to 18.0
|
Adverse Events
Autologous Conditioned Plasma (ACP)
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Normal Saline (NS)
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Autologous Conditioned Plasma (ACP)
n=60 participants at risk
3 Intra-articular (IA) injections at 1 week intervals
ACP: Autologous Conditioned Plasma
|
Normal Saline (NS)
n=30 participants at risk
3 NS Intra-articular (IA) injections at 1 week intervals
Placebo: Three Normal Saline IA injections of 3-8 mL at 1-week intervals.
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
1.7%
1/60 • Number of events 2 • 1 year
|
0.00%
0/30 • 1 year
|
|
Ear and labyrinth disorders
Ear Pain
|
1.7%
1/60 • Number of events 1 • 1 year
|
0.00%
0/30 • 1 year
|
|
Eye disorders
eye disorder
|
1.7%
1/60 • Number of events 1 • 1 year
|
0.00%
0/30 • 1 year
|
|
Gastrointestinal disorders
Diverticulitis
|
1.7%
1/60 • Number of events 1 • 1 year
|
0.00%
0/30 • 1 year
|
|
Gastrointestinal disorders
Virus
|
1.7%
1/60 • Number of events 1 • 1 year
|
0.00%
0/30 • 1 year
|
|
General disorders
Flu
|
3.3%
2/60 • Number of events 2 • 1 year
|
0.00%
0/30 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in Target knee
|
18.3%
11/60 • Number of events 17 • 1 year
|
26.7%
8/30 • Number of events 8 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain (not in target knee)
|
21.7%
13/60 • Number of events 16 • 1 year
|
33.3%
10/30 • Number of events 10 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
11.7%
7/60 • Number of events 9 • 1 year
|
3.3%
1/30 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Stiffness in target knee
|
5.0%
3/60 • Number of events 3 • 1 year
|
3.3%
1/30 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Tendinitis
|
1.7%
1/60 • Number of events 1 • 1 year
|
3.3%
1/30 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Atrophy
|
1.7%
1/60 • Number of events 1 • 1 year
|
0.00%
0/30 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Joint noises in target knee
|
5.0%
3/60 • Number of events 3 • 1 year
|
0.00%
0/30 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Decreased range of motion in target knee
|
1.7%
1/60 • Number of events 1 • 1 year
|
3.3%
1/30 • Number of events 1 • 1 year
|
|
Nervous system disorders
Headache
|
1.7%
1/60 • Number of events 1 • 1 year
|
3.3%
1/30 • Number of events 1 • 1 year
|
|
Nervous system disorders
Parasthesia
|
1.7%
1/60 • Number of events 1 • 1 year
|
0.00%
0/30 • 1 year
|
|
Nervous system disorders
Paralysis
|
1.7%
1/60 • Number of events 1 • 1 year
|
0.00%
0/30 • 1 year
|
|
Renal and urinary disorders
Renal calculi
|
0.00%
0/60 • 1 year
|
3.3%
1/30 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Urinary frequency
|
1.7%
1/60 • Number of events 1 • 1 year
|
0.00%
0/30 • 1 year
|
|
Renal and urinary disorders
Urinary pain
|
1.7%
1/60 • Number of events 1 • 1 year
|
0.00%
0/30 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
cold
|
6.7%
4/60 • Number of events 4 • 1 year
|
6.7%
2/30 • Number of events 2 • 1 year
|
|
Skin and subcutaneous tissue disorders
Injection site pain
|
0.00%
0/60 • 1 year
|
3.3%
1/30 • Number of events 2 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.3%
2/60 • Number of events 2 • 1 year
|
3.3%
1/30 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin CA
|
1.7%
1/60 • Number of events 1 • 1 year
|
0.00%
0/30 • 1 year
|
|
Skin and subcutaneous tissue disorders
Hematoma in target knee
|
3.3%
2/60 • Number of events 3 • 1 year
|
10.0%
3/30 • Number of events 5 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In the Clinical Trial Agreement between sponsor and PI it states, "Institution and clinical Investigator may not publish or publicly present the results of the study without the prior written approval of sponsor."
- Publication restrictions are in place
Restriction type: OTHER