← Back to Search

Other

Amniotic Fluid Injection for Osteoarthritis

Phase 1 & 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 3, 6 and 12 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am between 18 and 70 years old.
Select...
I have had knee pain for more than 4 months.
Select...
I have been diagnosed with moderate knee osteoarthritis.
Select...
My pain level has been 4 or more out of 10 in the past week.
Select...
I tried treatments like steroids or physical therapy for my condition without success in the last 3 months.
Select...
I can walk on my own without needing a wheelchair.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Repeat allogeneic intra-articular injection within 6 months.
Secondary outcome measures
Visual Analog Scale for pain (VAS Pain)
Other outcome measures
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Number of treatment emergent adverse events (AEs) directly related to the injection.
Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function Computer Adaptive Test (PF-CAT)
+2 more

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
1,099 Previous Clinical Trials
1,778,629 Total Patients Enrolled
9 Trials studying Osteoarthritis
1,133 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Massachusetts
Colorado
How old are they?
18 - 65
What site did they apply to?
University of Utah Orthopedic Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
Health and Quality of Life OutcomesJournal
[]
Roos, Ewa M, and Sören Toksvig-Larsen. 2003. “[]”. Health and Quality of Life Outcomes. Springer Science and Business Media LLC. doi:10.1186/1477-7525-1-17.
clinicaltrials.govStudy
pAF for the Treatment of Osteoarthritis
David Petron 2021. "pAF for the Treatment of Osteoarthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04886960.
All > Osteoarthritis > Oa
~5 spots leftby Jul 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top