pAF for the Treatment of Osteoarthritis

  • STATUS
    Recruiting
  • End date
    Jul 31, 2022
  • participants needed
    60
  • sponsor
    University of Utah
Updated on 15 September 2021

Summary

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

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.

Details
Condition Osteo Arthritis Knee
Treatment Standard of Care, Amniotic Fluid Injection
Clinical Study IdentifierNCT04886960
SponsorUniversity of Utah
Last Modified on15 September 2021

Eligibility

Yes No Not Sure

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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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