Study of Intra-articular Allocetra in Knee Osteoarthritis

Ki vehet részt

• Age 45 - 80 years
• Chronic osteoarthritis of index knee with knee-related joint pain
• Radiographic evidence of knee osteoarthritis of K-L Grade 2 or 3 in the index knee
• Knee pain assessed daily over a period of 7 days during the screening period and following wash-out of pain medications
• Patients with chronic knee pain for at least 3 months who have failed to respond adequately to conventional therapy
• Willing to abstain from other intra-articular treatments and adhere to the protocol restrictions for concomitant medications and therapies during the study
• Women of childbearing potential and all men must agree to use 2 methods of an adequate contraception prior to study entry and for the duration of study participation through 4 weeks following IP administration

Ki nem vehet részt

• Immunosuppressive therapy
• Any known current or prior tumor of the index knee
• Any major surgical cartilage treatment within 6 months
• Known coagulopathy, or use of anticoagulation medication or antiaggregant medication
• Any known history or current intra-articular or osseous infection of the index knee
• Any evidence of clinically significant active infection
• Any known history of inflammatory arthropathy or crystal-deposition arthropathy
• Any known severe systemic cartilage and/or bone disorder, such as, but not limited to, chondrodysplasia, osteogenesis imperfecta
• Clinically significant widespread pain syndromes, e.g., fibromyalgia, long COVID syndrome
• certain tumors, severe cardiac, respiratory or hematologic diseases as defined in the protocol
• Wheelchair bound
• Body Mass Index (BMI) >40
• Any ligamentous repair or malalignment correction in the index knee within 6 months
• Major injury to the index knee, such as torn ligament or severe sprain within 6 months
• Clinically relevant knee instability of the index knee
• Severe hip osteoarthritis ipsilateral to the index knee