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 @ 4:37 PM
Ignite Modification Date:
2025-12-24 @ 4:37 PM
NCT ID:
NCT04632966
Eligibility Criteria:
Inclusion Criteria:
* Written consent to participate in the study
* Male or female, aged 40 to 80 years
* Symptomatic knee OA with Kellgren-Lawrence radiographic classification of 2 or 3
* Non-responsive after at least 3 months of conservative therapy for knee OA
* Females of childbearing potential must have negative pregnancy test result prior to treatment and must commit to highly effective methods of contraception for at least 6 months after treatment
* Willingness to report oral analgesic treatment used for knee pain and to discontinue analgesic treatment for knee pain in 24 hours prior to each study visit
* Willingness to limit use of pain rescue medication to oral acetaminophen for management of painful knee OA flare
Exclusion Criteria:
* Body mass index (BMI) ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 with condition that warrants weight loss surgery
* Presence of active infection of index knee or systemic infection requiring treatment within 3 months of Screening
* Administration of IA injection within 3 months of Screening
* Significant acute injury to index knee within 3 months of Screening
* Surgery to index knee within 6 months of Screening or planned surgery to index knee within 6 months after Screening
* Unstable index knee joint
* History of radiation therapy of index knee
* Known vascular or neurological disorder affecting the index knee
* Osteonecrosis of either knee
* Clinical diagnosis of inflammatory arthritis
* Clinical diagnosis of autoimmune disease affecting the musculoskeletal system
* Use of any other investigational therapy within 3 months of Screening or planned for the duration of the study
* Current anti-coagulant use
* History of receiving a solid organ or hematologic transplant
* History of malignancy or radiotherapy within 5 years of Screening, except for basal or squamous cell carcinoma of the skin
* Use of immunosuppressive or chemotherapeutic agents within 5 years of Screening
* Known allergy to local anesthetics or allograft tissues
* Known history of hepatitis
* Known history of thrombotic or thromboembolic phenomena.
* Known history of primary or secondary immunodeficiency disorders
* Presence of concurrent medical condition that, in the investigator's judgement, could compromise participant safety or interfere with the required study assessments and study participation.
Note: Other protocol defined inclusion/exclusion criteria apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT04632966
Study Brief:
Protocol Section:
NCT04632966