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 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 1:14 AM
NCT ID:
NCT04719793
Eligibility Criteria:
Inclusion Criteria:
1. Patients must be 18 years or older.
2. Must have a body mass index (BMI) of \< 40Kg/m2.
3. Must be able to comply with the requirements of study visits.
4. Diagnosed with mild to moderate knee osteoarthritis (OA) in one knee only - Grade 2 or 3 on the KL grading scale.
5. Pain score of 4 or more on the NPRS (on scale of 0 to 10).
6. Female patients were abstinent, surgically sterilized or postmenopausal.
7. Premenopausal females with negative pregnancy test, and who does not anticipate pregnancy and will actively practice an accepted contraceptive method for the duration of study.
8. Males with premenopausal female partners, will take contraceptive measures for the duration of study.
9. Be willing and capable of giving written informed consent to participate in this clinical study.
10. Be willing and capable of complying with study-related requirements, procedures and visits.
Exclusion Criteria:
1. Patients who have taken any pain medications including NSAIDs within 15 days (except Acetaminophen), prior to the study injection date, regularly use anticoagulants, substance abuse history, and/or failure to agree not to take any knee-symptom modifying drugs during the course of the study without discussing and reporting the use to site principal investigator and study team.
2. Patients who are positive on special tests and stability tests on the physical exam case report form.
3. Patients with intraarticular injection of any drug including corticosteroids, viscosupplementation in the index knee in last 3 months.
4. Patients with index knee surgery within last 6 months.
5. Patients with traumatic injury to index knee within last 3 months.
6. Patients with planned elective surgery during the course of the study.
7. Patients with organ or hematologic transplantation history, rheumatoid arthritis or other autoimmune disorders.
8. Patients on immunosuppressive medication/treatment, diagnosis of non-basal cell carcinoma within last 5 years.
9. Patients with knee infection or who used antibiotics for knee infection within last 3 months.
10. Patients who participated in another clinical trial or treatment with any investigational product within last 30 days prior to inclusion in the study.
11. Female patients who are breast feeding or are pregnant or desire to be pregnant during the course of the study.
12. Patients with contraindication to X-ray or MRI imaging.
13. Patients with serious neurological, psychological or psychiatric disorders.
14. Patients with other medical conditions determined by site principal investigator as interfering with the study.
15. Patients with an injury or disability claim under current litigation or pending or approved workers' compensation claim.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04719793
Study Brief:
Protocol Section:
NCT04719793