Phase 1/2 randomized trial evaluating Allocetra™ intra-articular injection for the treatment of knee osteoarthritis

Condition

Knee osteoarthritis is a degenerative disease driven by physical breakdown of the joint cartilage, together with a chronic inflammation within the knee space. Over time, many patients will develop worsening pain in the joint and functional impairment, which may ultimately require knee replacement.

This study is assessing the safety and efficacy of Allocetra™ in patients suffering from painful knee osteoarthritis.

Assessments

• Reactions following treatment
• Change in knee pain and function

Inclusion and Exclusion Criteria

Inclusion Criteria:

1. Age 45 – 80 years.
2. Patients with osteoarthritis of index knee with chronic knee-related joint pain, who have failed to respond adequately to conventional therapy.
3. Radiographic evidence of knee osteoarthritis of K-L Grade 2 or 3 in the index knee.

Exclusion Criteria:

1. Any other disorder in the index knee: current or prior tumor, intra-articular or osseous infection, recent ligamentous repair or malalignment correction, recent major injury such as torn ligament or severe sprain, recent major surgical cartilage treatment, clinically relevant knee instability, severe hip osteoarthritis.
2. Any exclusionary systemic condition: inflammatory arthropathy or crystal-deposition arthropathy, severe systemic cartilage and/or bone disorder such as chondrodysplasia, osteogenesis imperfecta, clinically significant widespread pain syndromes, e.g., fibromyalgia, long COVID syndrome, wheelchair bound, immunosuppressive therapy, active infection, certain tumors, severe cardiac, respiratory or hematologic diseases as defined in the protocol.
3. Body Mass Index (BMI) >40