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Amniotic Fluid Injection for Osteoarthritis

Phase 1 & 2
Waitlist Available
Led By David Petron, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who are between the ages of 18-70 years
Unilateral or bilateral chronic knee joint pain >4 months
Must not have
Unable to consent to an English Language Consent Form
Rheumatoid arthritis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 3, 6 and 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if a sterile form of amniotic fluid can help treat osteoarthritis pain better than corticosteroids.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include reactions at the injection site, such as pain or swelling, allergic responses to components in the injections, and general risks associated with corticosteroids or amniotic fluid if applicable.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 70 years old.
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I have had knee pain for more than 4 months.
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I have been diagnosed with moderate knee osteoarthritis.
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My pain level has been 4 or more out of 10 in the past week.
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I tried treatments like steroids or physical therapy for my condition without success in the last 3 months.
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I can walk on my own without needing a wheelchair.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot consent to a form in English.
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I have rheumatoid arthritis.
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I suspect an infection where I got my shot.
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I haven't had any cancer except for skin cancer in the last 2 years.
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I have blood flow problems or nerve issues in my leg.
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I have not had any surgery except for diagnostic purposes in the last 4 weeks.
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I am diabetic with an HgA1c level of 8% or higher.
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I am not allergic to local anesthetics or the study drug's components.
Select...
I am currently pregnant or breastfeeding.
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I have a condition like arthritis or lupus.
Select...
My knee locks up.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 3, 6 and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 3, 6 and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Repeat allogeneic intra-articular injection within 6 months.
Secondary study objectives
Visual Analog Scale for pain (VAS Pain)
Other study objectives
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function Computer Adaptive Test (PF-CAT)
Single Assessment Numerical Evaluation (SANE)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Amniotic Fluid InjectionExperimental Treatment1 Intervention
Amniotic Fluid Injection, 3ml, one time dose.
Group II: Standard of Care Steroid InjectionActive Control1 Intervention
Corticosteroids, 3ml, one time dose.

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,147 Previous Clinical Trials
1,699,561 Total Patients Enrolled
10 Trials studying Osteoarthritis
1,233 Patients Enrolled for Osteoarthritis
David Petron, MDPrincipal Investigator - University of Utah Orthopaedic Center
University Of Utah Surgical Services, University Orthopaedic Center, University of Utah Hospital, VA Salt Lake City Health Care System
University Of North Dakota School Of Medicine (Medical School)
University Of Nd School Medical & Hlth Sci (Residency)

Media Library

Osteoarthritis Clinical Trial 2023: Amniotic Fluid Injection Highlights & Side Effects. Trial Name: NCT04886960 — Phase 1 & 2
Amniotic Fluid Injection (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04886960 — Phase 1 & 2
~14 spots leftby Dec 2025
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