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:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07313020
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of knee osteoarthritis according to internationally accepted criteria (e.g., American College of Rheumatology criteria).
2. Age between 18 and 75 years, inclusive.
3. Radiographic Kellgren-Lawrence grade II or III in the target knee.
4. Chronic knee pain of arthritic origin.
5. Absence of local or systemic infection.
6. No contraindications to joint cavity puncture as determined by hematological and biochemical tests.
7. Willing and able to understand the study, provide informed consent, and comply with all study procedures.
Exclusion Criteria:
1. Lack of legal capacity or impaired capacity to provide informed consent.
2. Known active infection with HIV, hepatitis B virus, hepatitis C virus, or syphilis (positive serology).
3. Body mass index (BMI) \> 30 kg/m².
4. Congenital or acquired deformity of the target knee.
5. Pregnant or breastfeeding women.
6. History of or current active malignancy.
7. Known immunodeficiency disorder.
8. Intra-articular injection (e.g., corticosteroids, hyaluronic acid) in the target knee within the past 3 months.
9. Concurrent participation in another interventional clinical trial.
10. Any other condition that, in the opinion of the investigator, would make the participant unsuitable for the study (e.g., significant comorbid illness).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07313020
Study Brief:
Protocol Section:
NCT07313020