pAF for the Treatment of Osteoarthritis (NCT04886960) | Clinical Trial Compass
CompletedPhase 1/2
pAF for the Treatment of Osteoarthritis
United States60 participantsStarted 2021-07-08
Plain-language summary
This is a Phase I/II Randomized Double-Blinded Standard of Care (Corticosteroid) vs. Sterile Amniotic Fluid for Osteoarthritis
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients who are between the ages of 18-70 years
* A confirmed diagnosis of knee osteoarthritis based on clinical and radiographic findings consistent with Kellgren-Lawrence Stage 2-3 disease
* Patients who have failed conservative treatment (e.g. steroid, activity modification, therapy, etc.) within 3 months
* Unilateral or bilateral chronic knee joint pain \>4 months
* Patients who are able to ambulate (i.e. not wheelchair bound)
* Patient reported a typical pain of at least 4 out of 10 during the past week using VAS numeric pain scale (0-10)
* Patients who are of childbearing potential must agree to use adequate contraception for 90 days after study drug injection
Exclusion Criteria:
* Subjects who have had a previous injection (i.e. steroid, platelet rich plasma, or other) within the last 3 months
* A focal chondral defect, defined by x-ray evaluation
* BMI \>40 as defined by NIH Clinical Guidelines Body Mass Index
* Concurrent participation in another investigational trial involving systemic administration of agents (within the previous 30 days) or plans to participate in any other allogeneic stem cell therapy trial during the 12 month follow-up period
* Clinical suspicion of infection at injection site
* Any surgeries within 4 weeks, other than diagnostic surgery
* Insulin or self-reported non-insulin dependent diabetic evident of HgA1c ≥8% among known diabetics
* Unable to consent to an English Language Consent Form
* Frank mechanical issues (i…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Repeat Allogeneic Intra-articular Injection Within 6 Months.