Effectiveness and Safety of CCoat Intra-Articular Injections in Mild to Moderate Knee Osteoarthritis

Ki vehet részt

• Subject has signed and dated the informed consent form
• Age ≥30 and ≤ 85 years old
• Pain in the intended study knee with an average VAS score (active) of ≥3 over the last week before screening
• Degenerative changes in the intended study knee that can be categorized as grade I -III- Kellgren Lawrence based upon standing anterior- posterior and lateral radiographsof the knee
• Body Mass Index (BMI) between 18.5 and 38
• A negative urine pregnancy test female patient with childbearing potential at Visit 1 prior to intra-articular injection of AqueousJoint
• If female, the subject must be either postmenopausal, OR permanently surgically sterile OR for women of childbearing potential using at least 2 methods of birth control that are effective from at least 30 days before Visit 1 through visit 26w (26 weeks post injection)
• Are willing or able to comply with procedures required in this protocol

Ki nem vehet részt

• History of significant knee trauma or previous surgery of the intended study knee within the last 3 months preceding the screening
• Intra-articular injection to the intended study knee within 3 months before Screening
• Intake of chronic pain medications (especially opioid pain relievers) without an option to pause for the period of the study
• Chemotherapy and/or radiation in the past 12 months
• Participation in other clinical trials within 60 days to before the study or concurrent with the study
• History of Psoriatic Arthritis, Rheumatoid Arthritis, or any other inflammatory condition associated with arthritis
• Any known history of intra-articular or osseous infection of the index knee
• Any evidence of active infection anywhere in the body. Urinary Tract Infection (UTI) patients can be included following antibiotic treatment, provided that two consecutive cultures are negative (taken within at least 2 weeks of each other)
• Any known history of inflammatory arthropathy or crystal-deposition arthropathy
• Any known systemic cartilage and/or bone disorder, such as but not limited to, chondrodysplasia or osteogenesis imperfecta
• Known history of a severe allergic reaction
• History of any significant systemic disease, such as but not limited to: HIV, hepatitis, HTLV, syphilis, and coagulopathies
• Known insulin dependent diabetes mellitus
• Osteoarthritis of the index knee graded 4 according to the Kellgren-Lawrence Grading
• Pain in both knees with a VAS score of ≥5
• Significant instability of the index knee
• Malalignment more than 10 degrees varus OR 10 degrees valgus according to standing X-ray
• Wound in the area of the intended study knee
• Any known tumor of the index knee
• Body Mass Index (BMI) > 38
• Active malignances, excluding BCC
• Patient who is pregnant or intends to become pregnant during the study
• A Known substance or alcohol abuse
• Unable to undergo X-ray