pAF for the Treatment of Osteoarthritis

March 5, 2026 updated by: David Petron, University of Utah

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will look at blinded standard of care (SOC) steroid injection vs. amniotic fluid injection (pAF) to treat and reduce osteoarthritis (OA) inflammation and pain. The main objectives of this study are to establish the safety and tolerability of allogeneic intra-articular pAF injections. Secondary objectives include pain levels and functional outcome scoring in patients over a 12 month time frame.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah Orthopedic Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Amniotic Fluid Injection
Amniotic Fluid Injection, 3ml, one time dose.
Biological: Amniotic Fluid Injection
Comparison of Standard of Care (Corticosteroid) injection vs. Sterile Processed Amniotic Fluid Injection for Knee Osteoarthritis
Other Names:
  • Processed Amniotic Fluid, pAF
  • Human Amniotic Fluid, hAF
Active Comparator: Standard of Care Steroid Injection
Corticosteroids, 3ml, one time dose.
Other: Standard of Care
Comparison of Standard of Care (Corticosteroid) injection vs. Sterile Processed Amniotic Fluid Injection for Knee Osteoarthritis
Other Names:
  • Corticosteriods 3ml, one time dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Repeat Allogeneic Intra-articular Injection Within 6 Months.
Time Frame: 6 months

Participants in both the SOC and pAF treatment arms may require and/or request rescue medication (i.e. SOC injection) at any time and will be given per PI discretion as part of standard of care. The clinicians will not know which study arm the study participant is in but will treat the participant with the SOC injection. This information will be documented and collected in the Electronic Medical Record (EMR), as well as the study's electronic data capture system. Participants will not be given any additional pAF injections throughout the study period.

The participant will continue to be treated with SOC injections as needed. The outcome will be an indicator of whether or not a subject received a rescue medication within 6 months.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: 6 months
Knee Injury and Osteoarthritis Outcome Score (KOOS) [assessment of joint symptoms, pain, and function on a scale from 0 to 100]. With higher scores representing better symptoms, pain and function.
6 months
Visual Analog Scale for Pain (VAS Pain)
Time Frame: 6 months
Pain was assessed using the Visual Analog Scale for pain (VAS), measured on a scale of 0 to 10. With 0 being no pain at all and 10 being the most pain possible.
6 months
Single Assessment Numerical Evaluation (SANE)
Time Frame: 6 months
Self-reported functional outcomes were evaluated throughout the study period using the Single Assessment Numerical Evaluation (SANE) [scored as a percentage of normal for the affected joint on a scale from 0-100%]. With higher values representing higher levels of function.
6 months
Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function Computer Adaptive Test (PF-CAT)
Time Frame: 6 months
Self-reported functional outcomes were evaluated using the PROMIS Physical Function Computer Adaptive Test [self-report of capabilities related to activities of daily living scored from 0 to 100]. With higher values representing higher levels of function.
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Treatment Emergent Adverse Events (AEs) Directly Related to the Injection.
Time Frame: 1 day, 2 days, 1 month, 3 months, 6 months, 12 months
One adverse event potentially related to the study injection (edema in lower extremity and foot, which resolved) was reported in the Amniotic Fluid treatment group, while no adverse events related to the injection were reported in the corticosteroid treatment group.
1 day, 2 days, 1 month, 3 months, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Investigators

  • Principal Investigator: David Petron, MD, University of Utah Orthopaedic Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2021

Primary Completion (Actual)

January 31, 2025

Study Completion (Actual)

January 31, 2025

Study Registration Dates

First Submitted

April 29, 2021

First Submitted That Met QC Criteria

May 10, 2021

First Posted (Actual)

May 14, 2021

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 128491

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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