Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT04886960
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04886960
Study Brief:
Protocol Section:
NCT04886960