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:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
NCT ID:
NCT05344157
Eligibility Criteria:
Major inclusion criteria:
* Aged ≥40 and ≤75 years at Screening
* Radiological evidence of predominantly medial osteoarthritis in the knee, uni- or bilateral, of KL grade II to III
* Moderate to severe pain associated with osteoarthritis in the knee as measured by a VAS pain score of ≥35 and ≤90 mm
Major exclusion criteria:
* Body mass index (BMI) of ≥35 at Screening
* Ongoing signs or symptoms of systemic or local infection
* Known knee infection in the study knee within 6 months of Screening
* History of clinically relevant concomitant joint disease, clinically-relevant knee deformities, or any clinically significant medical history of the ligament, or realignment surgery or joint replacement surgery
* Medical history of any autoimmune disease
* History of surgery in the study knee that occured within 6 months of Screening
* Treatment with immunosuppressive therapy (systemic or local) or any medication affecting the bone or cartilage metabolism within 6 months of Screening
* Patients who are immunocompromised as caused by a disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT05344157
Study Brief:
Protocol Section:
NCT05344157