Could amniotic fluid beat steroids for knee pain?
NCT ID NCT04886960
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compared a single injection of sterile amniotic fluid to the standard steroid shot for knee osteoarthritis. 60 adults with moderate knee arthritis who had not gotten relief from other treatments took part. The main goal was to see if the amniotic fluid could reduce the need for extra pain shots within 6 months. Researchers also tracked pain and knee function using standard surveys.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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60 people
The number who actually took part.
- Started
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Jul 2021
- Finished
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Jan 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.e. locking of the knee) * Workman's Compensation cases * Rheumatoid arthritis * Patients with a known allergy to local anesthetics or components of the study drug (pAF or steroid injection) * Patients with vascular claudication or neurologic disorders affecting the index lower limb * Patients with inflammatory arthropathies or connective tissue disorders; or * Patients with known alcohol or drug abuse or dependence, recreational use of illicit drug or prescription medications, or have used medical marijuana within 7 days of study enrollment * Patients with history of active cancer/malignancy within 2 years of screening, apart from adequately treated basal cell or squamous cell carcinoma of the skin not associated with the target knee * Women who are nursing or pregnant * Patients of childbearing potential who are unwilling to use adequate contraception for 90 days after study drug injection
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Utah Orthopedic Center
Salt Lake City, Utah, 84108, United States
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