Trial Outcomes & Findings for pAF for the Treatment of Osteoarthritis (NCT NCT04886960)
NCT ID: NCT04886960
Last Updated: 2026-03-27
Results Overview
Participants in both the SOC and pAF treatment arms may require and/or request rescue medication (i.e. SOC injection) at any time and will be given per PI discretion as part of standard of care. The clinicians will not know which study arm the study participant is in but will treat the participant with the SOC injection. This information will be documented and collected in the Electronic Medical Record (EMR), as well as the study's electronic data capture system. Participants will not be given any additional pAF injections throughout the study period. The participant will continue to be treated with SOC injections as needed. The outcome will be an indicator of whether or not a subject received a rescue medication within 6 months.
COMPLETED
PHASE1/PHASE2
60 participants
6 months
2026-03-27
Participant Flow
Patients will be screened and consented at the University of Utah Orthopedic Center and all participating sub-investigator's clinics when they come for a standard of care physical exam. During this exam, the patient will be asked about their health and lifestyle, medical history, and current medications. As part of the SOC physical exam, the patient will also have standard of care pre-treatment x-rays, neurological assessment, and a diagnosis of mild to severe OA in the knee joint assessment.
If the patient is found to be eligible for the study, research staff will approach the patient for informed consent. Patients with bi-lateral knee OA can participate but only one knee will receive the study treatment. The treating physician/principal investigator and the patient will discuss which knee should be treated with a study injection.
Participant milestones
| Measure |
pAF Injection
For the processed Amniotic Fluid (pAF) injection, the pAF injectate is prepared. The skin is prepped with Chloraprep. The skin is anesthetized using a freezing spray. 3 mLs of the pAF injectable solution is injected into the intra articular space of the knee. Ultrasound guidance will be used for all study injections.
|
Corticosteroid Injection
For the Corticosteroid injection, the skin is prepped with Chloraprep. The skin is anesthetized using a freezing spray. Then a mixture of 1 mL of Kenalog (corticosteroid) and 2 mL of ropivacaine is injected into intra-articular space of the knee. Ultrasound guidance will be used for all study injections.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
pAF for the Treatment of Osteoarthritis
Baseline characteristics by cohort
| Measure |
Corticosteroid Injection
n=30 Participants
For the Corticosteroid injection, the skin is prepped with Chloraprep. The skin is anesthetized using a freezing spray. Then a mixture of 1 mL of Kenalog (corticosteroid) and 2 mL of ropivacaine is injected into intra-articular space of the knee. Ultrasound guidance will be used for all study injections.
|
pAF Injection
n=30 Participants
For the processed Amniotic Fluid (pAF) injection, the pAF injectate is prepared. The skin is prepped with Chloraprep. The skin is anesthetized using a freezing spray. 3 mLs of the pAF injectable solution is injected into the intra articular space of the knee. Ultrasound guidance will be used for all study injections.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.9 years
STANDARD_DEVIATION 11.32 • n=56 Participants
|
62.3 years
STANDARD_DEVIATION 9.79 • n=62 Participants
|
60.1 years
STANDARD_DEVIATION 10.72 • n=123 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=56 Participants
|
14 Participants
n=62 Participants
|
29 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=56 Participants
|
16 Participants
n=62 Participants
|
31 Participants
n=123 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic or Latino
|
3 Participants
n=56 Participants
|
4 Participants
n=62 Participants
|
7 Participants
n=123 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Not Hispanic or Latino - Asian
|
1 Participants
n=56 Participants
|
1 Participants
n=62 Participants
|
2 Participants
n=123 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Not Hispanic or Latino - White
|
26 Participants
n=56 Participants
|
25 Participants
n=62 Participants
|
51 Participants
n=123 Participants
|
|
Body Mass Index
|
29 kg/m²
n=56 Participants
|
27 kg/m²
n=62 Participants
|
28 kg/m²
n=123 Participants
|
|
Kellgren-Lawrence Score
Grade 2
|
15 Participants
n=56 Participants
|
11 Participants
n=62 Participants
|
26 Participants
n=123 Participants
|
|
Kellgren-Lawrence Score
Grade 3
|
15 Participants
n=56 Participants
|
19 Participants
n=62 Participants
|
34 Participants
n=123 Participants
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Sport and Recreation Function subscale
|
50 Score on a scale
n=56 Participants
|
50 Score on a scale
n=62 Participants
|
50 Score on a scale
n=123 Participants
|
|
Visual Analog Scale (VAS) for pain
|
6 Score on a scale
n=56 Participants
|
6 Score on a scale
n=62 Participants
|
6 Score on a scale
n=123 Participants
|
|
Single Assessment Numerical Evaluation (SANE)
|
50 Percentage score
n=56 Participants
|
50 Percentage score
n=62 Participants
|
50 Percentage score
n=123 Participants
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function CAT
|
44 Scores on a scale
n=56 Participants
|
44 Scores on a scale
n=62 Participants
|
44 Scores on a scale
n=123 Participants
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Symptoms subscale
|
50 Score on a scale
n=56 Participants
|
50 Score on a scale
n=62 Participants
|
50 Score on a scale
n=123 Participants
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Pain subscale
|
56 Score on a scale
n=56 Participants
|
56 Score on a scale
n=62 Participants
|
56 Score on a scale
n=123 Participants
|
PRIMARY outcome
Timeframe: 6 monthsParticipants in both the SOC and pAF treatment arms may require and/or request rescue medication (i.e. SOC injection) at any time and will be given per PI discretion as part of standard of care. The clinicians will not know which study arm the study participant is in but will treat the participant with the SOC injection. This information will be documented and collected in the Electronic Medical Record (EMR), as well as the study's electronic data capture system. Participants will not be given any additional pAF injections throughout the study period. The participant will continue to be treated with SOC injections as needed. The outcome will be an indicator of whether or not a subject received a rescue medication within 6 months.
Outcome measures
| Measure |
Amniotic Fluid Injection
n=30 Participants
Amniotic Fluid Injection, 3ml, one time dose.
|
Standard of Care Steroid Injection
n=30 Participants
Corticosteroids, 3ml, one time dose.
|
|---|---|---|
|
Repeat Allogeneic Intra-articular Injection Within 6 Months.
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Three participants did not respond to the 6-month follow-up email within the designated follow-up period and were therefore excluded from the 6-month analysis.
Knee Injury and Osteoarthritis Outcome Score (KOOS) \[assessment of joint symptoms, pain, and function on a scale from 0 to 100\]. With higher scores representing better symptoms, pain and function.
Outcome measures
| Measure |
Amniotic Fluid Injection
n=28 Participants
Amniotic Fluid Injection, 3ml, one time dose.
|
Standard of Care Steroid Injection
n=29 Participants
Corticosteroids, 3ml, one time dose.
|
|---|---|---|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Symptoms subscale
|
75 Scores on a scale
Interval 50.0 to 75.0
|
50 Scores on a scale
Interval 50.0 to 75.0
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Pain subscale
|
75 Scores on a scale
Interval 56.0 to 88.0
|
69 Scores on a scale
Interval 50.0 to 75.0
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Sport and Recreation Function subscale
|
75 Scores on a scale
Interval 62.0 to 83.0
|
58 Scores on a scale
Interval 50.0 to 67.0
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SECONDARY outcome
Timeframe: 6 monthsPopulation: Three participants did not respond to the 6-month follow-up email within the designated follow-up period and were therefore excluded from the 6-month analysis.
Pain was assessed using the Visual Analog Scale for pain (VAS), measured on a scale of 0 to 10. With 0 being no pain at all and 10 being the most pain possible.
Outcome measures
| Measure |
Amniotic Fluid Injection
n=28 Participants
Amniotic Fluid Injection, 3ml, one time dose.
|
Standard of Care Steroid Injection
n=29 Participants
Corticosteroids, 3ml, one time dose.
|
|---|---|---|
|
Visual Analog Scale for Pain (VAS Pain)
|
3 Scores on a scale
Interval 2.0 to 6.0
|
5 Scores on a scale
Interval 3.0 to 7.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Three participants did not respond to the 6-month follow-up email within the designated follow-up period and were therefore excluded from the 6-month analysis.
Self-reported functional outcomes were evaluated throughout the study period using the Single Assessment Numerical Evaluation (SANE) \[scored as a percentage of normal for the affected joint on a scale from 0-100%\]. With higher values representing higher levels of function.
Outcome measures
| Measure |
Amniotic Fluid Injection
n=28 Participants
Amniotic Fluid Injection, 3ml, one time dose.
|
Standard of Care Steroid Injection
n=29 Participants
Corticosteroids, 3ml, one time dose.
|
|---|---|---|
|
Single Assessment Numerical Evaluation (SANE)
|
61 Percentage score
Interval 37.0 to 78.0
|
65 Percentage score
Interval 33.0 to 80.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Three participants did not respond to the 6-month follow-up email within the designated follow-up period and were therefore excluded from the 6-month analysis.
Self-reported functional outcomes were evaluated using the PROMIS Physical Function Computer Adaptive Test \[self-report of capabilities related to activities of daily living scored from 0 to 100\]. With higher values representing higher levels of function.
Outcome measures
| Measure |
Amniotic Fluid Injection
n=28 Participants
Amniotic Fluid Injection, 3ml, one time dose.
|
Standard of Care Steroid Injection
n=29 Participants
Corticosteroids, 3ml, one time dose.
|
|---|---|---|
|
Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function Computer Adaptive Test (PF-CAT)
|
48 Scores on a scale
Interval 44.0 to 52.0
|
44 Scores on a scale
Interval 39.0 to 47.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 day, 2 days, 1 month, 3 months, 6 months, 12 monthsOne adverse event potentially related to the study injection (edema in lower extremity and foot, which resolved) was reported in the Amniotic Fluid treatment group, while no adverse events related to the injection were reported in the corticosteroid treatment group.
Outcome measures
| Measure |
Amniotic Fluid Injection
n=30 Participants
Amniotic Fluid Injection, 3ml, one time dose.
|
Standard of Care Steroid Injection
n=30 Participants
Corticosteroids, 3ml, one time dose.
|
|---|---|---|
|
Number of Treatment Emergent Adverse Events (AEs) Directly Related to the Injection.
|
1 events
|
0 events
|
Adverse Events
Amniotic Fluid Injection
Standard of Care Steroid Injection
Serious adverse events
| Measure |
Amniotic Fluid Injection
n=30 participants at risk
Amniotic Fluid Injection, 3ml, one time dose.
|
Standard of Care Steroid Injection
n=30 participants at risk
Corticosteroids, 3ml, one time dose.
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal bleed
|
0.00%
0/30 • From enrollment, to 12 months
Adverse events were monitored throughout the study and recorded in an adverse event log. Participants were assessed at scheduled study visits and through follow-up communications. All serious adverse events observed during the study are reported, regardless of their relationship to study participation. All non-serious adverse events that exceeded a 5% frequency threshold within any study arm are reported.
|
3.3%
1/30 • From enrollment, to 12 months
Adverse events were monitored throughout the study and recorded in an adverse event log. Participants were assessed at scheduled study visits and through follow-up communications. All serious adverse events observed during the study are reported, regardless of their relationship to study participation. All non-serious adverse events that exceeded a 5% frequency threshold within any study arm are reported.
|
|
Cardiac disorders
Myocardial Infarction
|
3.3%
1/30 • From enrollment, to 12 months
Adverse events were monitored throughout the study and recorded in an adverse event log. Participants were assessed at scheduled study visits and through follow-up communications. All serious adverse events observed during the study are reported, regardless of their relationship to study participation. All non-serious adverse events that exceeded a 5% frequency threshold within any study arm are reported.
|
0.00%
0/30 • From enrollment, to 12 months
Adverse events were monitored throughout the study and recorded in an adverse event log. Participants were assessed at scheduled study visits and through follow-up communications. All serious adverse events observed during the study are reported, regardless of their relationship to study participation. All non-serious adverse events that exceeded a 5% frequency threshold within any study arm are reported.
|
Other adverse events
| Measure |
Amniotic Fluid Injection
n=30 participants at risk
Amniotic Fluid Injection, 3ml, one time dose.
|
Standard of Care Steroid Injection
n=30 participants at risk
Corticosteroids, 3ml, one time dose.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Total Knee Arthroplasty
|
3.3%
1/30 • From enrollment, to 12 months
Adverse events were monitored throughout the study and recorded in an adverse event log. Participants were assessed at scheduled study visits and through follow-up communications. All serious adverse events observed during the study are reported, regardless of their relationship to study participation. All non-serious adverse events that exceeded a 5% frequency threshold within any study arm are reported.
|
13.3%
4/30 • From enrollment, to 12 months
Adverse events were monitored throughout the study and recorded in an adverse event log. Participants were assessed at scheduled study visits and through follow-up communications. All serious adverse events observed during the study are reported, regardless of their relationship to study participation. All non-serious adverse events that exceeded a 5% frequency threshold within any study arm are reported.
|
Additional Information
Jamie Egbert, MPH
University of Utah Health: Department of Orthopaedics
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place