PAF for the Treatment of Osteoarthritis

Utah System of Higher Education (USHE)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Osteo Arthritis Knee

Treatments: Other: Standard of Care; Biological: Amniotic Fluid Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04886960

128491

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

60 participants in 2 patient groups

Amniotic Fluid Injection

Experimental group

Description:

Amniotic Fluid Injection, 3ml, one time dose.

Treatment:

Biological: Amniotic Fluid Injection

Standard of Care Steroid Injection

Active Comparator group

Description:

Corticosteroids, 3ml, one time dose.

Treatment:

Other: Standard of Care