Amniotic Fluid Injection for Osteoarthritis

Overseen By David Petron, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Utah

Must not be taking: Steroids, Platelet rich plasma

Disqualifiers: Diabetes, Rheumatoid arthritis, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 day

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a Phase I/II Randomized Double-Blinded Standard of Care (Corticosteroid) vs. Sterile Amniotic Fluid for Osteoarthritis

Who Is on the Research Team?

David Petron, MD

Principal Investigator

University of Utah Orthopaedic Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with knee osteoarthritis (Kellgren-Lawrence Stage 2-3) who can walk and have pain despite previous treatments. They must not be pregnant, nursing, or planning to become pregnant without using contraception for 90 days post-injection.

Inclusion Criteria

I have had knee pain for more than 4 months.

I have been diagnosed with moderate knee osteoarthritis.

Patients who are of childbearing potential must agree to use adequate contraception for 90 days after study drug injection

Exclusion Criteria

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

A focal chondral defect, defined by x-ray evaluation

I cannot consent to a form in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a one-time injection of either amniotic fluid or corticosteroids to treat osteoarthritis

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1, 3, 6, and 12 months

12 months

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Amniotic Fluid Injection
• Standard of Care

Trial Overview The study compares the effectiveness of a standard corticosteroid treatment against injections of sterile amniotic fluid in treating knee osteoarthritis. It's a Phase I/II trial where participants are randomly assigned to one of the two treatments without knowing which one they receive.

How Is the Trial Designed?

Group I: Amniotic Fluid Injection Experimental Treatment 1 Intervention

Amniotic Fluid Injection, 3ml, one time dose.

Group II: Standard of Care Steroid Injection Active Control 1 Intervention

Corticosteroids, 3ml, one time dose.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+